inform reporting and analysis - harvard university

InFormTM Integrated Trial Management Version 4.5

InForm Reporting and Analysis

I045-RA-RPAN-01

Copyright and Trademark Notice

Phase Forward is a provider of integrated enterprise-level software products, services, and hosted solutions for use in the clinical trial component of its customers' global research and development initiatives. Phase Forward is headquartered in Waltham, Massachusetts with offices in the United Kingdom, Australia, France and Japan. Additional information about Phase Forward is available at www.phaseforward.com.

Copyright © 2005 Phase Forward Incorporated. All rights reserved.

No part of this work may be reproduced or copied in any form or by any means—graphic, electronic, or mechanical, including photocopying, recording, taping, or information and retrieval systems—without written permission from the publisher:

Phase Forward 880 Winter Street Waltham, MA 02451

Phase Forward, InForm, InForm Architect, InForm Unplugged, Clintrial, Clintrace, the Phase Forward logo and/or other products or services of Phase Forward Incorporated are trademarks or registered trademarks of Phase Forward Incorporated in the U.S. Patent and Trademark Office and in other jurisdictions. Any other marks may be trademarks or registered trademarks of their respective owners.

Restricted Rights Legend

Use, duplication, or disclosure by the Government is available only with Restricted Rights as that term is defined in any applicable federal regulations.

Export Notice

Phase Forward products and services may be subject to export controls under applicable export control regulations, including without limitation, the United States Export Administration Regulations, and you agree to comply with any such regulations. You agree not to knowingly export or re-export any Software, Documentation, technical data or know-how, directly, or indirectly, into Iran, Iraq, Libya, Cuba, North Korea, Sudan, and Syria, or to any of its nationals or to any other countries or individuals of concern to the United States government.

i

Contents

About InForm vi

About this guide 1 About this guide..............................................................................................................................2 Style conventions ...........................................................................................................................3

InForm Reporting and Analysis 5 Overview: InForm Reporting and Analysis.....................................................................................6 Finding help for reporting ...............................................................................................................7 Understanding reporting data.........................................................................................................8

About the InForm Reporting database.................................................................................8 How data is made available for reporting ............................................................................8

How trial design affects reporting.................................................................................................14 Using optional trial elements..............................................................................................14 Reporting on subject status ...............................................................................................14 About DOV controls ...........................................................................................................15 About labels for clinical report elements ............................................................................15 Using calculation and conversion rules .............................................................................16

Reporting basics...........................................................................................................................17 The InForm Reporting and Analysis portal ........................................................................18 Running reports .................................................................................................................20 Scheduling reports .............................................................................................................23

InForm Ad Hoc Reporting 25 Overview: What is Ad Hoc Reporting?.........................................................................................26 How to access InForm Ad Hoc Reporting....................................................................................27 The InForm Ad Hoc Reporting workspace...................................................................................28 How to use the Ad Hoc Reporting tree.........................................................................................30 About Internal IDs.........................................................................................................................31 Element descriptions....................................................................................................................32

Reporting on trial management data 35 Study Info report elements ...........................................................................................................36

Study info: Study................................................................................................................36 Study Info: Sponsor ...........................................................................................................37 Study Info: Study Versions.................................................................................................39 Subject report elements .....................................................................................................40

Sites report elements ...................................................................................................................41 Sites ...................................................................................................................................41

Subject report elements ...............................................................................................................44 Subjects .............................................................................................................................44

ii Contents

Subjects: Subject Status (text)...........................................................................................46 Subjects: Subject Status Counts........................................................................................48 Subjects: CRB Status Counts ............................................................................................52 Subjects: Subject Status Dates..........................................................................................53 Subjects: Subject Status by Month and Year ....................................................................56

Visit report elements ....................................................................................................................58 Visits...................................................................................................................................59 Visits: Visit Properties ........................................................................................................60 Visits: Visit Counts by Property..........................................................................................62 Visits: Visit Status Counts ..................................................................................................63 Visits: Visit Dates ...............................................................................................................65

Forms report elements .................................................................................................................66 Forms .................................................................................................................................67 Forms: Properties ..............................................................................................................67 Forms: Form Counts by Property.......................................................................................70 Forms: Form Status Counts...............................................................................................72 Forms: Form Dates ............................................................................................................78 Forms: Form Status by Month and Year............................................................................82 Forms: Aging......................................................................................................................83 Forms: Cycle Times ...........................................................................................................84

Section report elements ...............................................................................................................87 Sections .............................................................................................................................87

Item report elements ....................................................................................................................88 Items ..................................................................................................................................88 Items: Item Properties........................................................................................................90 Items: Item Counts by Property .........................................................................................90 Items: Item Status Counts..................................................................................................91 Items: Item Dates...............................................................................................................93

Rule report elements....................................................................................................................94 Rules ..................................................................................................................................94

Query report elements .................................................................................................................96 Queries...............................................................................................................................96 Queries: Properties ............................................................................................................98 Queries: Query Counts ......................................................................................................99 Queries: Query Dates ..................................................................................................... 101 Query Status by Month, Year.......................................................................................... 103 Queries: Cycle Times...................................................................................................... 104 Queries: Aging ................................................................................................................ 105

Comment report elements......................................................................................................... 107 Comments....................................................................................................................... 107

User Info report elements.......................................................................................................... 109 User Info: Users .............................................................................................................. 109 User Info: Group Associations ........................................................................................ 111

Predefined filters ....................................................................................................................... 112 Filters .............................................................................................................................. 112

Reporting on clinical data 115 About the clinical reporting tree................................................................................................. 116 About reporting on clinical data................................................................................................. 118 Creating reports with both clinical and trial management data ................................................. 119 How clinical data is represented in the Ad Hoc Reporting tree................................................. 120

Understanding default labeling ....................................................................................... 120 About clinical report topics: forms and add-entry forms (itemsets)................................. 122 About code report elements............................................................................................ 123

Contents iii

About data that require units of measure........................................................................ 125 About itemsets, repeating visits, and repeating forms.................................................... 128 About deleted itemsets and form instances.................................................................... 134 About date controls ......................................................................................................... 137 About Incomplete Data Reasons .................................................................................... 140

Reporting on multi-instance forms and visits ............................................................................ 142

InForm Standard Reports 145 What makes up a standard report?........................................................................................... 146

About the report prompt page......................................................................................... 146 About the Report/Graph page......................................................................................... 150 About the Summary page ............................................................................................... 151

About data in Standard Reports................................................................................................ 152 Report folders............................................................................................................................ 153

About report actions........................................................................................................ 154 Running reports with options .......................................................................................... 156

Case Report Form (CRF) reports 157 CRF Aging by Site report .......................................................................................................... 158

Selection criteria: CRF Aging by Site prompt page ........................................................ 158 Report/Graph page: CRF Aging by Site ......................................................................... 160

CRF Aging by User report......................................................................................................... 163 Selection criteria: CRF Aging by User prompt page....................................................... 163 Report/Graph page: CRF Aging by User ........................................................................ 165

CRF Cycle Time Detail by Site.................................................................................................. 168 Selection criteria: CRF Cycle Time Detail by Site prompt page ..................................... 168 Report/Graph page: CRF Cycle Time Detail by Site ...................................................... 169

CRF Cycle Time Detail by User ................................................................................................ 173 Selection criteria: CRF Cycle Time Detail by User prompt page.................................... 173 Report/Graph page: CRF Cycle Time Detail by User..................................................... 174

CRF Site Performance Summary by Site ................................................................................. 179 Selection criteria: CRF Site Performance Summary by Site prompt page ..................... 179 Report/Graph page: CRF Site Performance Summary by Site ...................................... 180

CRF Site Performance Summary by User ................................................................................ 184 Selection criteria: CRF Site Performance Summary by User prompt page.................... 184 Report/Graph page: CRF Site Performance Summary by User..................................... 185

CRF Status Detail by Site and Subject ..................................................................................... 189 Selection criteria: CRF Status Detail by Site and Subject prompt page......................... 189 Report/Graph page: CRF Status Detail by Site and Subject .......................................... 191

CRF Status Detail by Visit and Site........................................................................................... 196 Selection criteria: CRF Status Detail by Visit and Site report prompt page.................... 196 Report/Graph page: CRF Status Detail by Visit and Site ............................................... 198

CRF Status Summary by Site ................................................................................................... 203 Selection criteria: CRF Status Summary by Site prompt page....................................... 203 Report/Graph page: CRF Status Summary by Site ........................................................ 205

CRF Status Summary by User.................................................................................................. 210 Selection criteria: CRF Status Summary by User prompt page ..................................... 210 Report/Graph page: CRF Status Summary by User....................................................... 212

iv Contents

Item reports 217 CRF Item Listing........................................................................................................................ 218

Selection criteria: CRF Item Listing ................................................................................ 218 Report/Graph page: CRF Item Listing ............................................................................ 220

Source Verification Listing......................................................................................................... 224 Selection criteria: Source Verification Listing.................................................................. 224 Report/Graph page: Source Verification Listing ............................................................. 226

Query reports 229 Outstanding Queries by Site and Visit ...................................................................................... 230

Selection criteria: Outstanding Queries by Site and Visit ............................................... 230 Report/Graph page: Outstanding Queries by Site and Visit ........................................... 231

Query Aging by Site .................................................................................................................. 233 Selection criteria: Query Aging by Site ........................................................................... 233 Report/Graph page: Query Aging by Site ....................................................................... 234

Query Cycle Times by Site........................................................................................................ 236 Selection criteria: Query Cycle Times by Site................................................................. 236 Report/Graph page: Query Cycle Times by Site ............................................................ 237

Query Cycle Times by User ...................................................................................................... 240 Selection criteria: Query Cycle Times by User ............................................................... 240 Report/Graph page: Query Cycle Times by User ........................................................... 241

Query Performance Summary by Site ...................................................................................... 244 Selection criteria: Query Performance Summary by Site ............................................... 244 Report/Graph page: Query Performance Summary by Site ........................................... 245

Query Performance Summary by User ..................................................................................... 248 Selection criteria: Query Performance Summary by User.............................................. 248 Report/Graph page: Query Performance Summary by User.......................................... 249

Query Status by Site ................................................................................................................. 252 Selection criteria: Query Status by Site report................................................................ 252 Report/Graph page: Query Status by Site ...................................................................... 253

Query Status by Site and Subject ............................................................................................. 256 Selection criteria: Query Status by Site and Subject ...................................................... 256 Report/Graph page: Query Status by Site and Subject.................................................. 257

Query Status by Site and Visit .................................................................................................. 260 Selection criteria: Query Status by Site and Visit ........................................................... 260 Report/Graph page: Query Status by Site and Visit ....................................................... 261

Query Status by User................................................................................................................ 264 Selection criteria: Query Status by User......................................................................... 264 Report/Graph page: Query Status by User..................................................................... 265

Query Volume by Month by Site ............................................................................................... 268 Selection criteria: Query Volume by Month by Site ........................................................ 268 Report/Graph page: Query Volume by Month by Site .................................................... 269

Query Volume by Month by User .............................................................................................. 272 Selection criteria: Query Volume by Month by User prompt page.................................. 272 Report/Graph page: Query Volume by Month by User................................................... 274

Query Volume by Rule .............................................................................................................. 276 Selection criteria: Query Volume by Rule report............................................................. 276 Report/Graph page: Query Volume by Rule................................................................... 277

Subject Counts with Outstanding Queries ................................................................................ 278 Selection criteria: Subject Counts with Outstanding Queries report............................... 278 Report/Graph page: Subject Counts with Outstanding Queries ..................................... 279

Contents v

Subject reports 281 Case Book Completion and Query Summary by Site ............................................................... 282

Selection criteria: Case Book Completion and Query Summary by Site report ............. 282 Report/Graph page: Case Book Completion and Query Summary by Site.................... 283

Case Book Completion and Query Summary by User.............................................................. 287 Selection criteria: Case Book Completion and Query Summary by User report ............ 287 Report/Graph page: Case Book Completion and Query Summary by User .................. 288

Cumulative Subject Enrollment by Month ................................................................................. 292 Selection criteria: Cumulative Subject Enrollment by Month report................................ 292 Report/Graph page: Cumulative Subject Enrollment by Month...................................... 293

Subject Dropout Count by Reason............................................................................................ 295 Selection criteria: Subject Dropout Count by Reason report .......................................... 295 Report/Graph page: Subject Dropout Count by Reason ................................................ 296

Subject Enrollment Status by Site............................................................................................. 298 Selection criteria: Subject Enrollment Status by Site...................................................... 298 Report/Graph page: Subject Enrollment Status by Site ................................................. 298

Subject Enrollment Status by User ........................................................................................... 303 Selection criteria: Subject Enrollment Status by User .................................................... 303 Report/Graph page: Subject Enrollment Status by User ................................................ 304

If you need assistance 309

Glossary 310

Index 319

vi InForm Reporting and Analysis

The InForm system is a data collection and trial management tool that harnesses the power of the Internet to provide access to clinical trial data and control of the clinical trial process.

About InForm

1

In This Chapter About this guide................................................................2 Style conventions .............................................................3

C H A P T E R 1

About this guide

2 InForm Reporting and Analysis

About this guide

InForm Reporting and Analysis provides an overview of the InForm Reporting and Analysis module. It provides a brief overview of the InForm Reporting and Analysis interface, illustrates how to access the ad hoc reporting feature, and describes the trial management and clinical data packages available for reporting. It also provides detailed descriptions of each of the standard reports included with your installation.

Intended Audience

This manual is for Clinical Research Associates (CRAs), Clinical Data Managers (CDMs), and other clinical trial professionals who create and run reports.

This guide does not provide tutorial information on how to perform basic tasks on your computer, or on the use of the Windows operating system. Users must have an understanding of basic computer concepts and experience using the specified operating system and all supporting software tools.

Cognos ReportNet information

Note that InForm software provides reporting capability through ReportNet, a reporting application developed by Cognos Corporation. While providing an overview of this software, InForm Reporting and Analysis does not detail the features of ReportNet. Complete information on Cognos ReportNet features appears in the ReportNet documentation. You should use the Cognos documentation set for complete information on creating, running, saving, and scheduling reports. You should also use Cognos documentation for information on Cognos Report Studio, if you have licensed that application.

To access this documentation, choose one of these actions:

Select Help->Using ReportNet Tools from the InForm Navigation pane. This links to an HTML page that gives you access to the complete Cognos ReportNet documentation set.

Click ReportNet Tools Help from the Ad Hoc Reporting workspace. This links directly to the Cognos Query Studio User Guide. (Note: Query Studio is the Cognos tool used by InForm to provide Ad Hoc Reporting capability.)

About this guide 3

Style conventions

This guide uses the style conventions listed in the following table.

Convention Purpose

Bold text Identifies window, dialog box, option, button, and menu command names.

Special Bold text Emphasizes the importance of a word or phrase.

Italicized text Identifies the first reference to a product-specific term, and identifies cross-references to the names of topics or sections in the document or to other documents.

Keys connected by the plus sign

Keys pressed simultaneously. For example, Ctrl+Alt+Delete.

Note Indicates reader take note. Notes contain supplemental information or suggested practices.

Caution Indicates caution. Cautions contain information that warn you about a condition, practice, or procedure that can cause loss of data.

[ ] In the page-level help, indicates a button.

> Indicates a sequence of menu selections. For example: From the Start menu, select Programs > InForm.

5

In This Chapter Overview: InForm Reporting and Analysis.......................6 Finding help for reporting .................................................7 Understanding reporting data...........................................8 How trial design affects reporting...................................14 Reporting basics.............................................................17

C H A P T E R 2



Overview: InForm Reporting and Analysis

The InForm Reporting and Analysis module is a reporting application, developed by Cognos Corporation, which has been customized and integrated into InForm software by Phase Forward, Incorporated.

See these topics for more information on InForm Reporting and Analysis:

Understanding reporting data—InForm reporting data resides within the InForm reporting database. This section describes the structure of the reporting database and provides an overview of how this data is made available to reporting users.

How trial design affects reporting—The design of each trial determines the kind of data that may or may not be available for reporting. This section highlights some ways in which trial design may affect the results you see in InForm reports.

Reporting basics—Concepts and tasks for using the InForm Reporting and Analysis interface are contained in the Cognos documentation set. This section provides a high-level discussion of some of these tasks and concepts.

Chapter 2 InForm Reporting and Analysis 7

Finding help for reporting

The Help button in the InForm navigation pane provides access to two different online help systems:

InForm and Trial Reporting—Provides access to InForm online help. Here, you can find information on using the InForm interface for the electronic data capture (EDC) process, administering InForm, and InForm reporting. Use this online help system to learn about InForm-specific details about reporting. This online help system describes each standard report in detail, and explains the data you can use to created ad hoc reports and. It also explains how trial design can affect reporting results.

Using ReportNet tools—Provides access to the Cognos documentation set. Use this help link to understand the mechanics of using the InForm Reporting and Analysis module, such as how to create different kinds of reports, how to create calculations and charts, and how to sort on different columns.

Additional help for reporting

Two additional links are provided in InForm to give you access to reporting help:

Report help—When you output any InForm Standard Report in HTML format, click the Report Help link. This link provides detailed page-level help is provided for each standard report.

ReportNet Ad Hoc tools help —When you access Ad Hoc Reporting, click the ReportNet Ad Hoc tools help link. This link provides access to the Cognos documentation for Query Studio (Query Studio is the Cognos application used by InForm to provide Ad Hoc Reporting capability.)


Understanding reporting data

About the InForm Reporting database All data used for InForm reporting resides in the InForm Reporting Database. The InForm Reporting Database is an Oracle database that is replicated from the InForm transactional database. Because reporting data is stored separately from InForm transactional data, your organization can write and run reports without affecting InForm software's performance.

Data in the Reporting Database is regularly updated and refreshed, allowing you to access to the most up-to-date information for your study.

The InForm reporting database contains two types of data:

Trial management data—-Metric and status data pertaining to the study. Using trial management data, you can report on the status of your study relative to its completion. You can report such things as the number of visits that have been completed for a study, or the number of forms that have been frozen or locked. Examples of trial management data are:

Site name Query count Frozen form count Last modified date for an item

The schema of the trial management portion of the reporting database is automatically installed with each InForm installation. It is not specific to your study.

Clinical reporting data—Data used to record clinical specifics of each subject visit. Using Clinical reporting data, you can report on specific clinical questions and responses. Examples of clinical data are:

Vital signs Dosing records Adverse events

The schema of the clinical reporting data portion of the reporting database is built from the forms installed with your trial. Therefore, the clinical data available for reporting is unique for each trial.

How data is made available for reporting This section explains how the information in the reporting database is made available for ad hoc and standard reports.


What is a data model?

A data model is a layer of the reporting database that describes the data objects, structure, grouping, data relationships, and security. InForm Reporting and Analysis uses one or more data models to make the data in the InForm Reporting Database available for your reports.

Two data models exist for every InForm trial. When your trial was installed, two data models were created:

Data model Description

Trial management data model A database layer that describes only the trial management portion of the reporting database.

Clinical data model A database layer that describes only the clinical portion of the reporting database.

A data model is internal to the system; it is not directly visible to you until it is published to a package.

What is a package?

A package is a grouping of data from one or more data models. Two packages are installed with every InForm trial. When your trial was installed, these packages were created:

Package Description InForm Trial Management A package that contains data from the Trial

Management data model only.

This package is installed with every InForm trial.

<name of trial> A package that contains data from both the Trial Management data model and the clinical data model (unique with each trial).

In Ad Hoc Reporting, you can see the structure of each package by its graphical representation, a reporting tree.


Report/package associations

Every report is associated with the package used to create it. That is, a report created with the InForm Trial Management package is associated with that package; a report created with the trial-specific clinical model is associated with that package.

All InForm Standard Reports are associated with the InForm Trial Management package. These reports can be used with any InForm installation

What is a reporting tree?

In Ad Hoc Reporting, you can see the structure of each package by its graphical representation, a reporting tree. The reporting tree appears in the Ad Hoc Reporting workspace.

Your InForm rights determine the information available to you in InForm Reporting and Analysis. You may or may not see all of the report elements shown here.


Icons used in the reporting tree

Use this table to understand the icons that appear in the reporting tree:

Icon Description

Package. The name of the package selected. This could be the InForm Trial Management package, or the trial-specific package, which contains both clinical and trial management data.

Report topic. Categories of different reporting areas. Forms, Visits, and Subjects are examples of report topics in the InForm Trial Management package.

Report element. Identifiers for the data you want to include in your report. Report elements appear as columns in list reports, and as rows and columns in crosstab reports. In charts, report elements appear as data markers and axis labels.

Measure or fact. A report element that represents a column of quantitative data in the database, such as visit count.

Filter. Mechanisms used to narrow reporting criteria. You can use filters that appear in the Predefined Filters folder in any report.

About the trial-specific clinical package

Using the trial-specific reporting package, you have access to both clinical and trial-management data for reporting.

The trial-specific clinical package consists of report topics and report elements from both the clinical and Trial Management data models.

The trial-specific reporting tree appears below:


When you should use the trial-specific package

Use the trial-specific package when you need to create reports that include clinical data. Note that, because clinical data is unique to each trial, report definitions using the trial-specific package may not be validated to work across different trials.


About the InForm Trial Management package

The InForm Trial Management package is installed with every installation of InForm Reporting and Analysis and is identical across trials. It contains report topics and elements from the Trial Management data model only.

The InForm Trial Management reporting tree appears below:

When you should use the InForm Trial Management package

Use the InForm Trial Management package when creating reports that will always contain trial management data only. Reports created with the InForm Trial Management package can be shared across trials.


How trial design affects reporting

This section describes how the way your trial is designed can impact ad hoc and standard reports.

Using optional trial elements Some elements of study design are specified only through design code are optional. Be aware that if your reporting requirements rely on the existence of optional data, you must design your trial to include such data.

Site, sponsor, and study information elements of trial design are optional and frequently left blank. Be aware that if these are not used in your trial design, ad hoc reports will contain blank values.

Reporting on subject status The status assigned to a subject depends on the use of InForm features through which the state is set. For instance, for a subject to have a randomized state, you must be performing subject randomization through InForm software.

This table outlines the requirements for subject status in InForm. If your organization is not taking advantage of these InForm features, be aware that subject status reporting capabilities will be limited in InForm Reporting and Analysis.

Subject status Required action in Inform Screened InForm Screening form must be successfully submitted for

the subject.

Enrolled InForm Enrollment form must be successfully submitted for the subject.

Screened Failed A screening form must be submitted for the subject. The subject subsequently fails the InForm screening process.

Enrolled Failed An enrollment form must be submitted for the subject. The subject subsequently fails the InForm enrollment process.

Enrolled Override InForm Enrollment Override process must be successfully completed after subject initially fails screening or enrollment.

Randomized Subject must be randomized in InForm software.

Dropped Out Study Completion form (as designed per InForm requirements) must be completed for the subject. The form must indicate that the subject has dropped out of the study.

Completed Study Completion form (as designed per InForm requirements) must be completed for the subject. The form must indicate that the subject has completed the study.


About DOV controls Form aging and cycle time reports show the amount of time it takes for data to be captured throughout various steps of the electronic data entry process. These calculations begin with the date of visit (DOV).

In trial design code, you can design DOV controls in a number of different ways. Phase Forward recommends designing DOV controls in a particular way, detailed in the InForm: Setting Up a Trial with InForm Architect and MedML guide. In general, the DOV control should:

have a specific Universal Unique Identifier (UUID) appear within a form section that is identified with a specific UUID not appear on a common form

InForm Reporting and Analysis retrieves DOV data from the database assuming that your study has been built in this way. The DOV used in reporting is a date entered by an InForm user into a DOV control designed with specific UUIDs mentioned above.

What if no date of visit is entered?

If you've designed your trial using the special DOV UUIDs, InForm users may still leave the DOV blank. If this is the case, DOV columns and columns containing calculations that rely on a DOV will be blank.

What if the date of visit entered is later than the data entry date?

If InForm users enter a DOV that is later than the data entry date, resulting reports show negative values in cycle time columns.

About labels for clinical report elements When defining an item, trial designers can specify a label in the Itemset Column Header property. If the item is used in an itemset, this label appears as the column heading in the row and column representation of the itemset.

In reporting, the Itemset Column Header property is also used as the default short name for the field in the clinical reporting model, whether or not the item is used in an itemset. (This value can be overridden if your organization chooses to customize the Ad Hoc Reporting tree.)


Using calculation and conversion rules Be aware that some trials may be designed to use calculations and conversions. Calculations and conversions enable you to set the value of a data item by performing a calculation that uses the value entered in one or more related items.

In some cases, a calculation or conversion may inadvertently change the data type of the data that populates the target item (though this is not advised in trial design). If this is the case, be aware that resulting reports cannot return data on the target item.

Consider this example:

An item called Gender appears on the Screening form of a trial. Valid values are numeric; the user can choose:

1-Male 2-Female

The value for this item is stored as a numeric in the database.

The trial is designed so that the Gender value entered on the Screening form automatically populates the Enrollment form. A rule applied to that item converts this value to a text string value (Male or Female) for display on the Enrollment screen, for example. This rule changes the data type from numeric to text string.

Be aware that, because of the change in data type, clinical reports on the Enrollment form in the above scenario will show blank values for Gender.


Reporting basics

This section describes some of the basics involved in using InForm Reporting and Analysis.

Complete information on Cognos ReportNet features appears in the ReportNet documentation. You should use the Cognos documentation set for complete information on creating, running, saving, and scheduling reports You should also use Cognos documentation for information on Cognos Report Studio, if you have licensed that application.





The InForm Reporting and Analysis portal InForm Reporting and Analysis portal is the first page that you see when you click Reports in the InForm navigation pane. By default, the Public Folders page displays when you first access the portal.

Report folders

From the InForm Reporting and Analysis folder, you can navigate to specific reports using the folders tabs, as follows:

Tab Description Public Folders tab Provides access to the InForm standard reports, as well as

custom reports that are shared with all users.

My Folders tab Provides access to reports that only you can access.


Portal icons

In the upper right corner of the InForm Reporting and Analysis portal are icons that let you perform actions on public or personal folders. These icons allow you to:

toggle between list and detailed folder views create new folders cut and paste folders delete folders set folder properties

Portal tools

The Tools drop down list allows you to choose different actions available from the portal. Note that your InForm rights control which options you see. Options are:

Tool Description Directory Allows you to create and manage

users, groups, and roles data sources distribution lists and contacts printers

Capabilities Allows you to control access to the ReportNet secured functions, such as Administration and Report Studio, and features, such as Bursting and User Defined SQL. The Capabilities tool is available to users who have access to the Administration function.

Schedule Management Allows you to view and manage schedules, to run a report, and to view report outputs. The Schedule Management tool is available to all users of ReportNet.

Server Administration Allows you to view and manage dispatchers and services and to tune the performance of ReportNet. The entries created in this tool are stored in the /Configuration area of the content store.

Deployment Allows you to export archives from a source environment and then import in a target environment.

Ad Hoc Reporting Launches InForm Reporting and Analysis Ad Hoc Reporting. (Note that the Cognos Query Studio application provides Ad Hoc Reporting capability for InForm.)

Report Studio Launches Cognos Report Studio. Note that Cognos Report Studio must be purchased separately from InForm Reporting and Analysis.

Preferences Allows you to change the default preferences for the InForm Reporting and Analysis portal.


Tool Description Logon Allows you to log in to other available namespaces.

ReportNet tools documentation

Details appear in the Cognos documentation set. To access this documentation:

1 Click Help from the InForm navigation pane

2 Choose Using ReportNet Tools. The Cognos documentation index appears.

Running reports The InForm Reporting and Analysis portal provides the following run report options that you use to generate report output:

Set Properties —allows you to set the characteristics of an ad hoc report including the report name, runtime options, and who can access it (not discussed in this lesson).

Run with Options—lets you specify the output format and delivery options for an ad hoc report at runtime (discussed next).

Open with Ad Hoc Reporting— gives you access to InForm Ad Hoc Reporting.

Schedule—you to specify when to generate an ad hoc report (discussed later in this course).

More link—gives you access to the features listed above as well as file management actions (Move, Copy, Create a shortcut, and Delete).

How to run a report

To run a report from the InForm Reporting and Analysis portal:

1 Navigate to the report you want to run. Links to InForm Standard Reports appear on the Public Folders tab. Links to customized reports will likely be located on the My Folders tab.

2 Click the Run with Options icon for the report you want to run. (Right-click this link to open the report in a new window.)

The Run with Options page appears for the applicable report.

3 Select Format, Language, and Delivery for the report and click Run. The report prompt page appears.

4 Complete the Selection Criteria and Sort Options sections of the page. (Details about selection criteria and sort options for each report are included in the documentation for each report.)

5 Click Run Report.


Phase Forward does NOT support XML and CSV formats for standard report output. Only HTML and PDF outputs are supported by Phase Forward.

To run an Ad Hoc report from the Ad Hoc Reporting workspace:

1 Click Run Report in the Ad Hoc Reporting menu.

2 Choose the option that best suits your needs. You can:

Run with all data

Preview with limited data

Preview with no data

Most users are not able to save report views in the Public Folders. However, if a user with sufficient rights does save a report in the Public Folders area, the link for the report brings up a saved report definition; that is, all selection criteria and sort options selected for the report are automatically saved with the definition. In this case, clicking the link for a saved report bypasses the report prompt page.

Running a report in a new window

Right-click the link for any report to launch a new browser window in which to display the report. Launching a new browser window is particularly helpful when you run reports that link back to InForm, such as the CRF Item Listing (on page 218) and the Source Verification Listing (on page 224).

Running a report with options

The Run with options page provides the following settings at ad hoc report runtime:

Format specifies the output format for the report: HTML on the screen

PDF in Adobe Acrobat Portable Document Format

Excel in single or multiple spreadsheet format (Available only for ad hoc reports; not supported for standard reports.)

CSV in comma-separated values. (Available only for ad hoc reports; not supported for standard reports.)

Language specifies the language in which to produce the report output. Note that only English is supported in this InForm release.

Delivery specifies any of three delivery mechanisms: View the report now to display the report output on the screen

Save the report to save the report output as a view in your personal folder (see hint below)

Print the report in PDF format to produce a hardcopy of the report in Adobe Acrobat PDF format on the specified printer


Prompt values identifies the values to present to the user when running the report.

Advanced options (see "Running a report with advanced options" on page 22) specifies additional options.

Saving the report output as a view produces a snapshot of the data at the time that you generate the report. This produces an archive that you can quickly review without having to regenerate the report output.

Running a report with advanced options

You can click Advanced Options from the Run with options page to display the Run with advanced options page that provides the following settings at ad hoc report runtime:

Time— specifies when to generate the ad hoc report: Now

A specified date and time Format— specifies the delivery format for the report output:

HTML (including the number of rows per page)

PDF (including the page orientation and paper size)

Excel

CSV (delimited text)

XML Language— specifies the language in which to produce the report output.

Note that only English is supported in this InForm release Delivery—specifies any of four delivery mechanisms:

View the report now

Save the report, print it, or send an email:

Print the report in PDF format

Send a link to the report by email Prompt values—Prompt values identifies the values to present to the user

when running the report.

Considerations for running reports with advanced options When you run reports with Advanced Options and set new prompt

values, note that clicking the Run Reports button does not actually run the report; instead, it saves the new prompt selections.

Note that, unless you have Publisher rights, you cannot email InForm standard reports (which appear in the Public Folder) from the Advanced Options menu. Emailing Standard Reports in this way requires that you save the report first. You cannot save reports to the Public Folders unless you have Publisher rights.


Turning off automatic summarization

Ad Hoc Reporting automatically suppresses duplicates. For example, if you add the report items Subject number and Site to a report, Ad Hoc Reporting shows only each unique combination of Subject number and Site once, rather than show all combinations that occur.

Ad Hoc Reporting also automatically summarizes detail values. For example, if you add the report items Visit Mnemonic and Form count to a report, you get one row for each Visit, with the Forms summarized for that Visit, rather than any of rows, showing each individual record.

You can turn off automatic summarization and duplicate suppression using these steps:

1 Create an ad hoc report.

2 Select Run Report from the Ad Hoc Reporting menu.

3 Select Advanced Query Options.

4 Click to deselect this option: Automatically summarize detail values, suppressing duplicates.

5 Click OK. The report redisplays, showing detail values rather than summaries.

Scheduling reports You can schedule reports to run automatically at times that are convenient for you. Details appear in the Cognos documentation set. To access this documentation:

1 Click Help from the InForm navigation pane

2 Choose Using ReportNet Tools. The Cognos documentation index appears.

If you choose to schedule reports, keep the following recommendations in mind:

Avoid scheduling reports during peak performance periods of the trial. If a trial has completed, remember to cancel any associated scheduled

reports.

25

In This Chapter Overview: What is Ad Hoc Reporting?...........................26 How to access InForm Ad Hoc Reporting ......................27 The InForm Ad Hoc Reporting workspace.....................28 How to use the Ad Hoc Reporting tree...........................30 About Internal IDs...........................................................31 Element descriptions ......................................................32

C H A P T E R 3

InForm Ad Hoc Reporting


Overview: What is Ad Hoc Reporting?

Ad Hoc Reporting is the InForm Reporting and Analysis module that allows you to create, run, and save your own customized reports on both clinical and trial-management data. Note that InForm Software provides Ad Hoc Reporting capabilities using the Cognos Query Studio application.

Phase Forward has removed labels referring to Query Studio in the InForm user interface and documentation to avoid confusion by clinical users to whom the term query means a clinical discrepancy, not a database operation.

Chapter 3 InForm Ad Hoc Reporting 27

How to access InForm Ad Hoc Reporting

Use this procedure to access the InForm Ad Hoc Reporting module.

1 Choose Reports from the InForm navigation pane.

The InForm Reporting and Analysis portal appears.

2 Choose Ad Hoc Reporting from the portal Tools drop down list.

The Select a package page appears.

3 Click the link for the package with which you want to work, as follows:

To choose the trial-specific clinical package (containing both clinical and trial management data), click the link that reflects the name of your trial.

To choose the InForm Trial Management package, click InForm Trial Management.

The InForm Ad Hoc Reporting workspace appears. The reporting tree reflects the package you selected.

The Ad Hoc Reporting selection is available to you only if you have sufficient rights.


The InForm Ad Hoc Reporting workspace

The InForm Ad Hoc Reporting workspace appears below:

The following parts comprise this workspace:

Ad Hoc Reporting menu—Allows you to toggle selections for inserting and editing data, saving reports, running reports, and change layout. Options on the Ad Hoc Reporting menu are: Insert data—Displays the Ad Hoc Reporting tree

Edit data—Lets you modify data on the report. For instance, you can apply filters, sort, add calculations, summarize columns. You can also cut, paste, and delete data. You can also undo and redo changes.

Change layout—Lets you modify the presentation of your report. For instance, you can create charts, group and ungroup columns, pivot columns, create sections in your report, swap rows and columns, and collapse and expand groups.

Run report—Lets you specify options for running the report. For instance, you can run the report with all data, run the report with limited data, or preview the report with no data. You can also specify an output format for your report.

Manage file—Allows you to create and save reports

Tools—If you have purchased Report Studio and have sufficient rights to access it, you can do so using this menu.


Ad Hoc Reporting tree— Makes data available for reporting. Link to Cognos Query Studio Doc— Launches online help for Cognos Query

Studio, which provides Ad Hoc Reporting capability to InForm software. ReportNet tools— Allows you to perform operations on ad hoc reports,

including saving, cutting and pasting data, applying filters, and summarizing data.

Report palette—The area onto which you drag report topics and elements to create ad hoc reports.


How to use the Ad Hoc Reporting tree

You can create ad hoc reports by:

Dragging and dropping report elements and topics on the Ad Hoc Reporting tree into the Ad Hoc Reporting workspace. When you drag a report topic, all report elements it contains appears as columns in the ad hoc report. When you drag a report element, a single element appears as a column in the ad hoc report.

Double-clicking any report topic or element. When you double-click a report topic, all report elements it contains appear as columns in the ad hoc report. When you double-click a report element, a single element appears as a report column in the ad hoc report.


About Internal IDs

Each report topic contains an Internal IDs folder. These folders contain unique database identifiers for various study components.

Internal IDs are provided to allow advanced technical users to write efficient reports; these can improve overall report performance when used by users with a solid knowledge of the reporting database.

All reporting users can take advantage of these specific internal IDs to enhance their reports:

SUBJECTID—When creating reports using clinical data, you must be sure to include a unique identifier for the study component on which you want to report. For example, to create a clinical report about a particular subject, you must use whatever identifier uniquely identifies the subject in your study. Depending on your study design, you may choose to use SUBJECTID instead of Subject Number, which in some designs may not be unique.

FORMINDEX , ITEMSETINDEX, and VISITINDEX—Use these report elements with repeating forms, items, and visits if you want to report on status information for individual instances of repeating forms or repeating visits.


Element descriptions

The description of each element may include the following:

Data displayed—The type of data returned in the report. Possible values are:

Numeric String (text) Date/Time Y/N

Description—A brief description of the element.

How calculated—(Included only for counts) Details about how data is calculated.

Data source—A description of where the data came from. Possible values are:

Data source Description Replicated from the InForm Transactional database to the Reporting database (not a derived value.)

This data resides in both the InForm Transactional database and in the InForm Reporting database.

Replicated from the InForm Transactional database to the Reporting database. Database value has been decoded for display.

This data resides in both the InForm Transactional database and in the Reporting database. The value has been derived for display. For example, A Y/N value that displays in a report may be stored as a 0/1 value in the database.

Derived by InForm Ad Hoc Reporting. Not stored in the InForm Reporting database

This data is derived on the fly when you run a report. The data does not appear in any InForm database.

Derived and stored in the InForm Reporting Database.

This data is derived by InForm Reporting and Analysis and resides only in the InForm Reporting database.

Date type—(Included only for dates) A description of the type of date displayed. Possible values are:

Date type Description System date (GMT) A date recorded by InForm at data entry.

System date and time (GMT) A date and time recorded by InForm at data entry.

System date (GMT), derived for display A date recorded by InForm, but derived for display. For example, the Form Status by Month, Year report element returns only the Month and Year portion of the date.

Reporting database system date and time. A system date on the Reporting database server.

Clinical A date entered by an InForm user, in local time.


Date type Description Specified in trial design code. A date specified in the trial MedML.

May be specified in trial design code. If not, this is a system date.

A date that may be specified in the trial MedML. If it is not, the date is a date recorded by InForm at data entry.

Tip—Additional information about the report element

Example—An example to help illustrate a calculation or concept

35

This section describes each report element included in the InForm Trial Management package.

In This Chapter Study Info report elements .............................................36 Sites report elements .....................................................41 Subject report elements .................................................44 Visit report elements.......................................................58 Forms report elements ...................................................66 Section report elements .................................................87 Item report elements ......................................................88 Rule report elements ......................................................94 Query report elements....................................................96 Comment report elements............................................107 User Info report elements.............................................109 Predefined filters ..........................................................112

C H A P T E R 4

Reporting on trial management data


Study Info report elements

Use the Study Info report elements to include information about the study, the study sponsor, and study version in your reports.

Many Study Info elements reflect data that is optional for each study. Reports will not display data for these elements if they have not been used for your study.

Study info: Study Study Info: Study report elements report on high-level specifics of the study.

Study Info: Study Report element Description Study Name Data displayed: String

Description: The name associated with the study, as specified in the trial design code.

Data source: Replicated from the InForm Transactional database to the Reporting database (not a derived value.)

Trade Drug/Device Name

Data displayed: String

Description: The proprietary, trademark-protected name under which the drug, device, biologic, or compound is being marketed. This name is specified in the trial design code.


Generic Drug/Device Name


Description: The name used for the generic, therapeutic equivalent of the brand-name drug, device, biologic, or compound (if any). This name is specified in the trial design code.


Sponsor Drug/Device Name


Description: The name the sponsor uses to refer to the drug, device, biologic, or compound being studied. This name is specified in the trial design code.


Refresh Time Data displayed: Date/Time

Description: The last date and time the reporting data was refreshed. Note that this time reflects the last time data was refreshed in the InForm Reporting Database, regardless of whether data was changed.

Date type: Reporting database system date and time.

Chapter 4 Reporting on trial management data 37

Study Info: Study Report element Description Transaction Time Data displayed: Date/Time

Description: The most current InForm transaction time.

Date type: System date and time (GMT)

Study Info: Sponsor Study Info: Sponsor report elements let you report on specifics about the study's sponsor.

Many study info elements retrieve data that is optional; this data may or may not specified in your trial design. If data is not specified, report elements return blank values.

Study Info: Sponsor Report element Description Sponsor Name Data type: String

Description: The name of the sponsor of the study.


Note Data type: String

Description: An optional description of the study, specified in the trial design code.


Address 1 Data type: String

Description: The text stored in the Address 1 line for the trial sponsor.


Address 2 Data type: String

Description: The text stored in the Address 2 line for the sponsor.


City Data type: String

Description: The city in which the trial's sponsor is located.



Study Info: Sponsor Report element Description State/Province Data type: String

Description: The state or province in which the trial's sponsor is located.


Country Data type: String

Description: The country in which the trial's sponsor is located.


Postal Code Data type: String

Description: The postal code for the sponsor's location.


Phone Data type: String

Description: The sponsor's primary telephone number.


Alt Phone Data type: String

Description: The sponsor's secondary telephone number.


Fax Data type: String

Description: The sponsor's fax number.


Email Data type: String

Description: An email address specified by the sponsor for a primary contact related to the study.


Therapeutic Area Data type: String

Description: The medical area being investigated by the trial. Note that use of the Therapeutic Area field varies from sponsor to sponsor.



Study Info: Sponsor Report element Description Program Name Data type: String

Description: The name of the medical program into which the study can be categorized. Program names might be medical areas such as Oncology, Dermatology, and so forth.

Note that use of the Program name field varies from sponsor to sponsor.


Study Info: Study Versions Study Info: Study Versions reporting topics let you report on data about the particular study versions.

Study Info: Study Versions Report element Description Version Data displayed: String

Description: The name associated with a given study version, as specified in the trial design code. This report element returns all study versions.


Version Date Data displayed: Date/Time

Description: The date the study version was defined for the trial.

Date type: May be specified in trial design code. If not, this is a system date.

Description Data displayed: String

Description: Text used to describe what has changed in this study version. Study version description text is unique to each study version. Often, this field is used to reflect the iteration of a particular study. For example, a 2 in this field may indicate that the study version is the second revision.



Study Info: Study Versions Report element Description Design Note Data displayed: String

Description: Optional notes for the study version entered in the trial design code.


Sponsor Approval Date

Data displayed: Date/Time

Description: The projected date on which the Sponsor will be approved the InForm study version. Note that this date is set by the trial designer. It does not necessarily reflect the actual date the study version goes live.

Date type: Specified in trial design code.

Subject report elements Subject report elements and measures allow you to create reports that provide metrics and status information about subjects during the course of the study.

The elements and measures in this report topic return trial management data. You can use these elements and measures to access such data as current status, status dates, and counts.

These elements and measures do not provide any clinical information about a subject. You can create reports that contain clinical data about subjects only if you have access to both trial management and clinical items and measures in your reporting package.


Sites report elements

Site report elements and measures allow you to create reports that provide identifying and descriptive data for all sites in a given study. Use the Sites report topic when you want to see information broken out by each site participating in the study.

Sites Site report elements return data specific to each site. Most of these elements reflect optional data. If data is not entered for any of these optional values, the resulting reports yields blank results.

Sites Report element Description Site Name Data displayed: String

Description: The name of the site, as entered in the InForm Administration interface.


Site Mnemonic Data displayed: String

Description: An abbreviation used to identify a site, as entered in the InForm Administration interface.


Address 1 Data displayed: String

Description: First line of the site address, as entered in the InForm Administration interface.


Address 2 Data displayed: String

Description: Second line of the site address, as entered in the InForm Administration interface.


City Data displayed: String

Description: The city in which a site is located, as entered in the InForm Administration interface.



Sites Report element Description State/Province Data displayed: String

Description: The state or province in which the site is located, as entered in the InForm Administration interface.


Country Data displayed: String

Description: The country in which a site is located, as entered in the InForm Administration interface.


Postal Code Data displayed: String

Description: The postal code for the site's address, as entered in the InForm Administration interface.


Phone Data displayed: String

Description: The primary telephone number for the study site, as entered in the InForm Administration interface.


Alt Phone Data displayed: String

Description: The site's secondary telephone number, as entered in the InForm Administration interface.


Fax Data displayed: String

Description: The fax number for a study site, as entered in the InForm Administration interface.


Email Data displayed: String

Description: The email address for a site contact, as entered in the InForm Administration interface.


Time Zone Data displayed: String

Description: The timezone in which a study site is located, as entered in the InForm Administration interface.



Sites Report element Description Date Format Data displayed: Numeric

Description: The format used for all references to dates for the site. Valid values are:

1—Day/Month/Year

2—Year/Month/Day

3—Month/Day/Year


Site Activation Date Data displayed: Date/Time

Description: The projected date for the activation of the study by the site. It does not necessarily reflect the actual date on which the activation occurs.


Current Study Version Data displayed: String

Description: Displays a description of the most current study version, as specified in the trial design code. Many trial designers use this field to indicate study version iteration. For example, 2 indicates the second version of the study. The value may also be a textual description for the study version.


Current Site Acceptance Date


Description: The date on which the site was assigned to the current study version


Note that the date that appears here depends on how the site was associated with the current study version

If the site was associated with the study version through the InForm Administration interface, the Current Site Acceptance Date is the system date when the association took place.

If the site was associated with the study version through the MedML installer, this date is the date specified in the MedML for the new study version.



Subject report elements

Subject report elements and measures allow you to create reports that provide metrics and status information about subjects during the course of the study.

The elements and measures in this report topic return trial management data. You can use these elements and measures to access such data as current status, status dates, and counts.

These elements and measures do not provide any clinical information about a subject. You can create reports that contain clinical data about subjects only if you have access to both trial management and clinical items and measures in your reporting package.

Subjects Subjects report elements return identifying information about the subject. This report topic also includes a count element, allowing you to see totals for subjects, regardless of status.

Subjects Report element Description Subject Number Data displayed: String

Description: The number that identifies the subject.

The subject number is automatically assigned to the subject when the subject's screening form is completed and submitted. This number can also be changed post enrollment, if configured in the trial.

Note that:

Subject number may or may not be unique at your site The subject number field is called Patient Number in the

InForm user interface.

This value is called Patient Number in the InForm user interface.


Subject Initials Data displayed: String

Description: The initials of the subject enrolled in the trial. These initials can be changed post enrollment.



Subjects Report element Description Subject DOB (Screening)

Data displayed: Date

Description: The date of birth for the subject, as entered on the subject's Screening form in InForm software. The DOB field may or may not be used on the Screening form for your study.

Note that this date cannot be changed after the subject is enrolled. (It can be changed after the Screening form is submitted, as long as the subject has not yet been enrolled.)

Many trial designers also include a date of birth field for the subject on other clinical forms in the study to correct data entry errors that might have occurred when the subject was screened. Unlike the DOB field on the screening form, a DOB field on a clinical form CAN be changed at any time.

As a result, a subject may have two different dates of birth recorded in the reporting database; one recorded on the Screening form, and one recorded on another clinical form in the study. These dates may or may not match.

You can report on clinical DOB dates using report element that appear in the Clinical Data by Form folder

Date type: Clinical.


Subjects: Subject Status (text) The elements in the Subjects: Subject Status (text) reporting topic allow you to create reports that describe subject status.

The Subject states listed here are states internal to InForm software. They may or may not correlate with clinical state definition, since events like screening and randomization are often performed outside of InForm software.

Subjects: Subject Status Report element Description Subject Status Data displayed: String

Description: The current InForm status assigned to the subject. This value reflects the InForm status of the subject; subjects can be in only one state at a time in InForm software. Valid values are:

Screened—The Screening form for the subject was started, but the subject is not enrolled. This covers these cases: The subject is fully screened, but the enrollment form has

not been started. The subject is fully screened and the enrollment process

has started but not completed. Screen Failed— The subject has failed the InForm screening

process. Enroll Failed—The subject has passed the InForm screening

process, but failed the enrollment process. Enrolled—Indicates the subject was properly enrolled in

InForm software, but has not reached the status of randomized, completed, or dropped out.

Randomized—The subject was enrolled and has been randomized in InForm software, but is not yet completed or dropped out.

Complete— The subject has completed the study, as recorded in the Complete control of the Study Completion form for that subject.

Dropped out—The subject has dropped out of the study, as recorded in the Complete control of the Study Completion form for that subject.


Screen Failure Reason Data displayed: String

Description: Text that indicates why the subject failed the screening process in InForm software.



Subjects: Subject Status Report element Description Enroll Failure Reason Data displayed: String

Description: Text indicating why the subject failed enrollment in InForm software.


Enroll Override Reason


Description: Text indicating why the screening or enrollment failure has been overridden for the subject in InForm software.


Drop Out Reason Data displayed: String

Description: Text that indicates why the subject dropped out of the study in InForm software. The drop out reason is clinical data that is specified on the Study Completion form for the subject.

Note: This report displays only those reasons that were specified when subjects dropped out of the study. If a drop out reason was never used, it does not appear in this report.



Subjects: Subject Status Counts The Subjects: Subject Status Counts folder contains reporting elements that calculate counts of subjects based on subject state. The Subject states listed here are states internal to InForm software. Whether these states correlate to actual clinical states depends on your use of InForm software features.

About status counts

A subject can be in only one state at a time in InForm software. Therefore, if a subject is randomized after being enrolled in InForm software, the subject's current state is randomized, and not enrolled.

However, when you create reports on subjects who are still actively participating in the trial, you will likely need to see totals that reflect how many subjects have ever been enrolled in the trial. For example, a count of enrolled subjects should include all subjects who have ever been enrolled in InForm software, even if their status has changed to randomized. This is because, in clinical terms, a subject who has been randomized is still considered enrolled. Therefore, these subject status counts return totals of subjects who have ever had these states:

Screened Enrolled Enrolled Override Randomized

To report on subjects who are no longer active in the trial, use the Screened Failed, Enrolled Failed, Dropped Out, and Complete subject status counts. Unlike the other subject status counts, these report element return totals of those subjects currently in any of these states. Keep in mind, however, that subjects will have dropped out and completed status only if the Study Completion form is being used for your study.

The status assigned to a subject depends on the use of InForm software features. See Reporting on subject status (on page 14) for more information.

Tip: You can use any of the predefined subject filters to further qualify the Subject Status Count totals.


Subjects: Subject Status Counts Report element Description Subject Count Data displayed: Numeric

Description: The number of subjects who have ever participated in the study.

How calculated: All subjects, regardless of status, are included in this count. This count includes all screened, enrolled, randomized, dropped, and completed subjects.

Data source: Derived and stored in the InForm Reporting Database.

Tip: You can use any of the predefined subject filters to further qualify this count.

Screened Data displayed: Numeric

Description: The number of subjects who have ever been in the screened state in InForm software.

How calculated: A subject is counted if he/she has ever been assigned a screened status in InForm software. This count includes subjects whose states have changed from screened to a new state.

Data source: Status is determined by Inform Screening form and stored in the Reporting database. The status count is derived from the status and is set to 1 when the subject enters that status. This fact is stored in the Reporting Database.

Screen Failed Data displayed: Numeric

Description: The number of subjects who have a current status of screened failed in InForm software.

How calculated: A subject is counted if the InForm screening process rejected the subject, based on some screening eligibility requirement that was not met. Note that subjects can have a status of screened failed in InForm software only if screening eligibility requirements are being used for your study.

A subject is not counted if the screen failure was overridden for the subject.

Data source: Status is determined by Inform Screening form and stored in the Reporting database. The status count is derived from the status and is set to 1 when the subject enters that status. This fact is stored in the Reporting Database.


Subjects: Subject Status Counts Report element Description Enrolled Data displayed: Numeric

Description: The number of subjects who have ever been enrolled in the study through InForm software.

How calculated: A subject is counted if an Enrollment form was completed and successfully submitted for the subject. Note that this count includes subjects whose states have changed from enrolled to a new state; the count includes all subjects who have ever been in the enrolled state. This count includes subjects who have gone through the enroll-override process.

Data source: Status is determined by Inform Enrollment form and stored in the Reporting database. The status count is derived from the status and is set to 1 when the subject enters that status. This fact is stored in the Reporting Database.

Enrolled Failed Data displayed: Numeric

Description: The number of subjects who have a current status of enrolled failed in InForm software.

How calculated: A subject is counted if InForm software rejected the subject's enrollment form, based on some eligibility requirement that was not met. This count includes subjects whose current states have changed from enrolled failed to a new state.

A subject is not counted if the enroll failure was overridden for the subject.

Note that subjects can have this status only if the enrollment eligibility requirements are being used in InForm software for your study.

Data source: Status is determined by Inform Enrollment form and stored in the Reporting database. The status count is derived from the status and is set to 1 when the subject enters that status. This fact is stored in the Reporting Database.

Tip: You can use any of the predefined subject filters to further qualify this total.

Enrolled Override Data displayed: Numeric

Description: The number of subjects who initially failed the InForm screening or enrollment process, but whose failure was overridden in InForm software.

How calculated: A subject is counted if the subjects were screened or enrolled successfully through the InForm Enrolled Override process. Note that this count includes all subjects whose status has changed from enrolled override to a new status.

Data source: Status is determined by Inform Screening/Enrollment override process and stored in the Reporting database. The status count is derived from the status and is set to 1 when the subject enters that status. This fact is stored in the Reporting Database.


Subjects: Subject Status Counts Report element Description Randomized Data displayed: Numeric

Description: The number of subjects in the study who have ever been randomized in InForm software. Subjects have a status of randomized immediately after they have been randomized with the InForm randomization feature.

How calculated: A subject is counted if the subject has ever been randomized in InForm software. This count includes subjects whose status has changed from randomized to a new status.

Note that if you randomize subjects outside of InForm software, the randomized subject count will always be 0.

Data source: Status is determined by Inform Randomization feature and stored in the Reporting database. The status count is derived from the status and is set to 1 when the subject enters that status. This fact is stored in the Reporting Database.

Dropped Out Data displayed: Numeric

Description: The number of subjects who have a current status of dropped out.

How calculated: A subject is counted if the subject has dropped out of the study, as recorded in the Study Completion form for that subject.


Subject Complete Data displayed: Numeric

Description: The number of subjects who have a current status of complete.

How calculated: A subject is counted if the subject's current status is complete, as recorded in the Study Completion form for that subject.



Subjects: CRB Status Counts The Subjects: CRB status counts return metrics on the number of casebooks in various states. Note that CRB states are set at the casebook level only. A CRB state is not set by actions performed on individual forms within the casebook.

Subjects: CRB Status Counts Report element Description CRB Started Data displayed: Numeric

Description: The number of case books that have been started in InForm software.

How calculated: A case book is counted as started when a noncommon form from the first visit in the case book is started. (A form is started when any data, queries or comments have been entered on the form.)


CRB SV Ready Data displayed: Numeric

Description: The number of the case books with a current status of SV ready in InForm software.

How calculated: A case book is counted if its current status is SV Ready in InForm software.


CRB Frozen Data displayed: Numeric

Description: The number of frozen casebooks.

How calculated: A casebook is counted if its current status is frozen in InForm software.


CRB Signed Data displayed: Numeric

Description: The number of case books that have been signed.

How calculated: A case book is counted if its current status is signed in InForm software.


CRB Locked Data displayed: Numeric

Description: The number of locked case books.

How calculated: A case book is counted if its current status is locked in InForm software.



Subjects: CRB Status Counts Report element Description CRB w/ Query Data displayed: Numeric

Description: The number of the case books that have at least one opened or unanswered query.

How calculated: A case book is counted if at least one form in the case book has at least one opened or answered query. Note that a case book is not counted if the only query associated with any of its forms is a candidate query.


Subjects: Subject Status Dates The Subjects: Subject Status Dates report elements return dates when subjects were assigned to particular states in InForm software.

Tip: You can use First and Last dates below to achieve different reporting purposes:

Use Last dates to determine a subject's current status, and the date on which the status change occurred.

Use the First and Last dates together to identify subjects who have been, but are no longer, in a particular state.

Subjects: Subject Status Dates Report element Description Subject Status Date Data displayed: Date/Time

Description: The date the subject was assigned the current subject status. For example, If the current subject state is complete, the Subject Status date indicates the date on which the complete state was assigned to the subject.

Date type: System date (GMT)

InForm Screened Date Data displayed: Date/Time

Description: The date on which the subject was screened for the study in InForm software. .A screened status indicates that the Screening form for the subject was started, but the subject is not yet enrolled. This covers these cases:

The subject is fully screened, but the enrollment form has not been started.

The subject is fully screened and the enrollment process has started but not completed.



Subjects: Subject Status Dates Report element Description InForm Enrolled Date Data displayed: Date/Time

Description: The date on which the subject was enrolled in the InForm software. A status of enrolled indicates the subject was properly enrolled in InForm software, but has not reached the status of randomized, completed, or dropped out.


InForm Screen Failure Date


Description: The date on which the subject failed the screening process in InForm software.


InForm Randomized Date


Description: The date on which the subject was randomized through InForm software. A status of randomized indicates that a subject was enrolled and randomized in InForm software, but is not yet completed or dropped out.

Note that if you perform randomization outside of InForm software, this element returns a blank value.


First Dropped Date Data displayed: Date/Time

Description: The date the subject first dropped out of the study, as recorded in the Study Completion form for that subject.


Last Dropped Date Data displayed: Date/Time

Description: The date on which the subject most recently dropped out of the study, as recorded in the Study Completion form for that subject.

If the subject is removed from the dropped out state, this element returns a blank value.


Subject First Complete Date


Description: The first date on which the subject completed the study, as recorded in the Study Completion form as designed per InForm requirements.


Subject Last Complete Date


Description: The most recent date on which the subject completed the study, as recorded in the Study Completion form as designed per InForm requirements. The value listed in the resulting ad hoc report is null if the subject is removed from the complete state.



Subjects: Subject Status Dates Report element Description CRB SV Ready Date Data displayed: Date/Time

Description: The date the case book was marked SV Ready in InForm software.


CRB Frozen Date Data displayed: Date/Time

Description: The date the casebook was frozen in InForm software. Note that if the CRB is unfrozen, the report element returns a null value.


CRB Signed Date Data displayed: Date/Time

Description: The date the casebook was signed in InForm software. Note that if the CRB is not signed, the report element returns a null value.


CRB Locked Date Data displayed: Date/Time

Description: The date the casebook was locked in InForm software. Note that if the CRB is not locked, this report element returns a null value.



Subjects: Subject Status by Month and Year The Subject Status by Month and Year report elements let you create reports on subject status by month. Use these report elements with subject status counts to see the number of subjects who were assigned a particular status each month.

If the report is sorted by one of the Month/Year report elements, the resulting report displays each month, January through December of 1999 through 2008. (You can apply a filter to specify a date range to one appropriate for your trial.) You can then add the Subject Count element to see how many forms were assigned a particular status in each month.

The following report shows how many subjects were enrolled each month:

Subjects: Subject Status by Month and Year Report element Description Subject Status Month, Year


Description: Each month/year combination, from January 1999 to December 2008. Use this column with Subject Count to see the month and year each subject was assigned his or her current InForm status.

Date type: System date (GMT), derived for display.


Subjects: Subject Status by Month and Year Report element Description Screened Month, Year Data displayed: Date/Time

Description: Each month/year combination, from January 1999 to December 2008. Use this column with Subject Count to see how many subjects were screened in InForm software each month.


Enrolled Month, Year Data displayed: Date/Time

Description: Each month/year combination, from January 1999 to December 2008. Use this column with Subject Count to see how many subjects were enrolled each month.


Randomized Month, Year


Description: Each month/year combination, from January 1999 to December 2008. Use this column with Subject Count to see how many subjects were randomized in InForm software each month.


Subject Complete Month, Year


Description: Each month/year combination, from January 1999 to December 2008. Use this column with Subject Count to see how many subjects were completed each month.


Dropped Month, Year Data displayed: Date/Time

Description: Each month/year combination, from January 1999 to December 2008. Use this column with Subject Count to see how many subjects dropped out of the InForm trial each month.



Visit report elements

Visit report elements allow you to create reports on visit properties, status, and dates.

About visit types

Trials designed for InForm software are made up of a number of different visit types. Some visit types are used to gather clinical data from subjects. These are:

Subject Visit-—A visit used to gather clinical data within the subject's casebook.

Common Visit—An internal mechanism used to contain common forms used in the study.

Other visit types are used to gather non-clinical data. These are:

Screening—The visit that contains the Screening form, used for InForm screening. Note that the Screening visit is not included in the subject's casebook.

Enrollment—The visit that contains the Enrollment form, used for InForm enrollment. Note that the Enrollment visit is not included in the subject's casebook.

Reg Docs—-An internal mechanism used to record information about a review of the study documentation.

Visit Report—An internal mechanism used to record information about a monitor's visit to a site.

When you create ad hoc reports, keep in mind that all visit types are included in general visit counts; if you want to limit your reports to clinical visit counts only, be sure to use a predefined filter. (see "Predefined filters" on page 112)


Visits Visit report elements return identifying information about the visit.

Visits Report element Description Visit Mnemonic Data displayed: String

Description: Abbreviation of the visit title, as specified in trial design code. For CRF visits, this name appears at the top of a collection of forms in the visit timeline. Note that the visit mnemonic may not be a unique identifier.


Visit Name Data displayed: String

Description: The complete name that identifies the visit in the InForm system, as specified in trial design code. Note that the visit name is not a unique identifier.



Visits: Visit Properties Visit Properties report elements return information about the type of visit.

Visits: Visit Properties Report element Description Visit Type Data displayed: String

Description: The type of visit. Valid types are:

Subject Visit-—A visit used to gather clinical data within the subject's casebook.

Common Visit—An internal mechanism used to contain common forms used in the study.

Screening—The visit that contains the Screening form, used for InForm screening. Note that the Screening visit is not included in the subject's casebook.

Enrollment—The visit that contains the Enrollment form, used for InForm enrollment. Note that the Enrollment visit is not included in the subject's casebook.

Reg Docs—-An internal mechanism used to record information about a review of the study documentation.

Visit Report—An internal mechanism used to record information about a monitor's visit to a site.

Tip: If you want to report on only clinical data, filter this column to include only common and subject visits.

Data Source: Replicated from the InForm Transactional database to the Reporting database. Database value has been decoded for display.

Start Hours Data displayed: Numeric

Description: Number of hours from the subject's enrollment to the start of the visit. This number is specified in the trial design code and is used to create the proposed schedule of visits shown in the Visit Calculator when a subject is enrolled.


Is Scheduled Visit Data displayed: Y/N

Description: Indicates whether the visit is a scheduled visit. Scheduled visits occur in a fixed relationship to the beginning of a subject's enrollment in a study. Scheduled visits start a specified number of hours after enrollment.

Valid values are:

Y—The visit is scheduled. N—The visit is not a scheduled visit.



Visits: Visit Properties Report element Description Is Repeating Visit Data displayed: Y/N

Description: Indicates whether the visit is a repeating visit. Repeating visits are those that occur multiple times within a study.

Repeating visits are always unscheduled.

Valid values are:

Y—The visit is a repeating visit. N—The visit is not a repeating visit.


Is Dynamic Visit Data displayed: Y/N

Description: Indicates whether the visit is a dynamic visit or not. Dynamic visits are created automatically when subject data satisfies certain criteria that you test by attaching a rule to a form item.

Valid values are:

Y—The visit is dynamic. N—The visit is not dynamic.


Dynamic Projected Start Hours

Data displayed: Numeric

Description: The number of hours after the study starts that this visit is scheduled to take place. This value is used for dynamic scheduling of a visit.


Visit Order Data displayed: Numeric

Description: A number that indicates the relative order of the visit within the study.

Tip: Use Visit Order to sort visits in a report. This is helpful if the visit order is not implied in the Visit Mnemonic or Visit Name.


Design Note Data displayed: String

Description: Optional text containing special information about the visit, specified in the trial design code. This information is for documentation only and is not displayed in the InForm software.



Visits: Visit Counts by Property Visit Counts by Property report elements return totals of different types of visits.

Note that these visit counts are totals of all subject visits, regardless of visit type. To report on clinical visits only, use the Clinical Visits filter, in the Predefined Filters folder.

Visits: Visit Counts by Property Report element Description Scheduled Visit Data displayed: Numeric

Description: The number of scheduled subject visits, regardless of visit type.

How calculated: This calculation includes:

all scheduled visits all started dynamic visits all started unscheduled visits


Repeating Visit Data displayed: Numeric

Description: The number of started repeating (unscheduled) visits.

How calculated: A visit is counted if it is repeating (unscheduled) and has been started.


Dynamic Data displayed: Numeric

Description: The number of started dynamic visits.

How calculated: A visit is counted if it is dynamic and has been started.



Visits: Visit Status Counts Visit Status Count report elements return visit totals by their status. Note that visit states are derived from the state of each form within each visit. For example, a visit is considered completed only if all forms within the visit must have a status of complete.

Note that visit status or several items below here does not correlate to status indicators on the InForm patient list.

Visits: Visit Status Counts Report element Description Visit Count (Across subjects)


Description: The total number of subject visits for the study.

How calculated: All subject visit instances are counted, regardless of visit type or status. Note that this count includes non-clinical visits. (You can apply a predefined filter if you want to limit visit counts to clinical visits only.)

In addition to counting Visits that have expected forms (including activated dynamic visits), this count includes unscheduled visits.


Visit Started Data displayed: Numeric

Description: The number of visits that have a non-common form that has been started in InForm software.

How calculated: A visit is counted as started if at least one non-common expected form in the visit has been started.

Data Source: Derived by InForm Reporting and Analysis (not stored in the Inform Reporting database).

Visit Complete Data displayed: Numeric

Description: The number of visits where each expected form has a current status of complete in InForm software.

How calculated: A visit is counted as complete if all of the expected forms in the visit have a current status of complete.

Note: Visit status reported here differs from visit status indicated by the traffic light icon in the InForm interface.

Visit complete in Ad Hoc Reporting —All expected forms must be complete for the visit to be considered complete.

Visit complete in InForm interface—At least one started form must be complete for the visit to be considered complete.



Visits: Visit Status Counts Report element Description Visit Frozen Data displayed: Numeric

Description: The number of visits where each expected form has a current status of frozen in InForm software.

How calculated: A visit is counted as frozen if all of the expected forms in the visit have a current state of frozen in InForm software.

Note: Visit status reported here differs from visit status indicated by the traffic light icon in the InForm interface.

Visit complete in Ad Hoc Reporting —All expected forms must be frozen for the visit to be considered frozen.

Visit complete in InForm interface—At least one started form must be frozen for the visit to be considered frozen.


Visit SV Complete Data displayed: Numeric

Description: The number of visits where each expected form has been source verified in InForm .

How calculated: A visit is counted as source verified if all of the expected forms in the visit have a current status of source verified in InForm software.

Note: Visit status reported here differs from visit status indicated in the InForm interface.

Visit Source Verified in Ad Hoc Reporting —All expected forms must be source verified for the visit to be considered source verified.

Visit Source Verified in InForm interface—At least one started form must be source verified for the visit to be considered source verified.


Visit Locked Data displayed: Numeric

Description: The number of visits where each expected form has a status of locked in InForm software.

How calculated: A visit is counted as locked if all of the expected forms in the visit have a current status of locked.

Note: Visit status reported here differs from visit status indicated in the InForm interface.

Visit Locked in Ad Hoc Reporting —All expected forms must be locked for the visit to be considered locked.

Visit Locked in InForm interface—At least one expected form must be locked for the visit to be considered locked.



Visits: Visit Dates Visit Dates report elements return dates associated with visits.

Visits: Visit Dates Report element Description Scheduled Date Data displayed: Date

Description: The date on which the visit is scheduled.

How calculated: This date is calculated by adding the value in the visit's Start Hour property to the enrollment date.


Actual Date (DOV) Data displayed: Date

Description: The date recorded in a standard Date of Visit t control in InForm software. Note that this report element retrieves a date stored when your DOV controls are designed in a specific way. See About DOV controls (on page 15) for more information.


Data Entry Date Data displayed: Date

Description: The date data was entered for the visit. This date is equal to the first date any form is submitted for the visit.



Forms report elements

Forms report elements and measures allow you to create reports that provide metrics and status information about forms that comprise the study. Use this report topic to include:

counts of different form types information about form properties and states information on when forms were initially created and changed

About Form elements and expected forms

Unless otherwise noted, all of the calculations and dates returned by elements in the Forms report topic are based on expected form counts.

A form is counted as expected if it meets any of these criteria:

It appears within a scheduled visit (regardless of whether the form is started)

It appears within a started unscheduled visit It is a dynamic form that has been activated

Expected forms are counted only for subjects that have enrolled in InForm software (includes enrolled, randomized, completed, and dropped).

For subjects that have completed or dropped (as indicated by the Study Completion form), only forms in started visits or dynamic started forms are counted. Non-started common forms are not counted as expected.

The expected forms calculation assumes the following:

Only subject visits and common visits are counted. Other special visits such as screening/enrollment, monitor, and so forth are not included.

Alternate forms—An alternate form is counted as expected only if it has been started.

Dynamic forms—Dynamic forms are counted only when activated unless the form has been deleted (removed).

Repeating forms—For repeating forms that have not been started, one instance of the form is counted as expected. For repeating forms that have been started, each started instance counts as expected. Deleted form instances are not counted as expected.

Common forms—A common form is counted only once, regardless of the number of visits in which it occurs. This count includes common forms that appear in unscheduled visits that have not started. Common forms that have not been started for subjects that have completed or dropped out of the trial are not included in the expected forms count.

Common repeating forms—Each started instance is counted once. If no instances have been started, it is counted once.

Common dynamic forms—Each activated or started instance is counted once.


Dynamic repeating forms—Each activated or started instance is counted once.

Common dynamic repeating forms—Each activated or started instance is counted once.

Forms Form report elements return identifying information about forms.

Forms Report element Description Form Mnemonic Data displayed: String

Description: A short name or abbreviation for the form, specified in the trial design code. This name appears on the Visit Navigation tab and is used to access a specific form in InForm software.


Form Name Data displayed: String

Description: The complete name that identifies the form in the InForm software.


Forms: Properties Forms: Properties report elements return information about the properties associated with forms.

Forms: Properties Report element Description Form Type Data displayed: String

Description: Displays the type of form. Valid values are:

CRF—Identifies a form used in a clinical subject visit. Enrollment—Identifies forms used in Screening and Enrollment

visits. Monitor RegDoc— Identifies forms used in Regulatory

Documentation visits. Monitor Visit Report—Identifies forms used for Visit Reports.

Use the predefined form filters with this element to limit the data on your report to a particular form type.

Data Source: Derived by InForm Reporting and Analysis (not stored in the Inform Reporting database). Value decoded for display.


Forms: Properties Report element Description Is Dynamic Data displayed: Y/N

Description: Specifies whether the form is dynamic. Valid values are:

Y: The form is dynamic N: The form is not dynamic


Is Repeating Data displayed: Y/N

Description: Specifies whether the form is a repeating form. Valid values are:

Y: The form is a repeating form N: The form is not a repeating form

A repeating form occurs multiple times in the same visit or trial. For example, if a protocol calls for multiple blood draws at intervals after administering a medication, you can capture the repeating data on multiple instances of a repeating form.


Is Common Data displayed: Y/N

Description: Specifies whether the form is a common form. Valid values are

Y: The form is a common form N: The form is not a common form


Is Alternate Form Data displayed: Y/N

Description: Specifies whether the form is an alternate form.

Valid values are:

Y: The form is an alternate form N: The form is not an alternate form



Forms: Properties Report element Description Contains SV Required Items

Data displayed: Y/N

Description: Specifies whether the form contains items that require Source Verification.

Valid values are:

Y: The form contains SV Required items N: The form does not contain SV required items


Contains Required Items

Data displayed: Y/N

Description: Specifies whether the form contains items that require data entry for the form to be complete.

Valid values are:

Y: The form contains required items N: The form does not contain required items


Form Order Data displayed: Numeric

Description: An ordinal, specifying the form's position within the visit. For instance, 3 indicates that the form is the third form in the visit.


Design Note Data displayed: String

Description: Optional text, specified in trial design code, used by trial designers for documentation purposes only. This note does not appear in the InForm interface.


Form Note Data displayed: String

Description: Optional text, specified in trial design code, that appears on the form.



Forms: Form Counts by Property Form Counts by Property report elements return totals of different types of forms. Form counts here are expected form counts.

Note that, when used by themselves, these report elements return form totals multiplied by the number of subjects participating in the study. You can add other report elements to see different totals for specific subjects.

Form Counts by Property Report element Description Dynamic Form Data displayed: Numeric

Description: The number of expected dynamic forms.

How calculated: A form is counted if it is a dynamic form and has been activated or started. A dynamic form is not counted if it has been removed.

Example: A subject (who is pregnant) is participating in a trial that requires additional information be collected for subjects who are pregnant. A dynamic form is activated for the subject when data entered indicates she is indeed pregnant.

Dynamic form count for this example = 1.


Repeating Form Data displayed: Numeric

Description: The number of started, non-started, and deleted repeating forms contained within the study.

How calculated: A repeating form that has not been started is counted once. Each started instance of a repeating form is counted once.

Example: Two subjects are participating in a trial with a repeating form that records blood draws at different intervals within the trial. Subject A has had one blood draw; therefore one instance of the repeating form has been started for the subject. Subject B has had two blood draws; two instances of the repeating form have been started for Subject B.

Repeating form count for this example =3.


Common Form Data displayed: Numeric

Description: The number of possible common forms across all subjects.

How calculated: A common form is counted once, regardless of the number of visits in which the form appears.

Example: A trial contains a common form for Adverse Events, which appears in each visit. This form has been completed for a subject in three different visits.

Common form count for this example = 1



Form Counts by Property Report element Description Alternate Form Data displayed: Numeric

Description: The number of possible alternate forms across all subjects.

How calculated: A form is counted if it is an alternate form and has been started.

Example: An alternate form is completed for two subjects enrolled in the study

Alternate form count for this example: 2


Has Required Items Data displayed: Numeric

Description: The number of possible expected forms across all subjects that contain required items.

How calculated: A form is counted if it is possible to be expected or started and contains required items. This calculation includes dynamic and repeating forms with required items, as follows:

Dynamic forms—A dynamic form is counted if it contains required items and is activated or started. Dynamic forms are not counted if they have been removed.

Repeating forms—A repeating form that has not been started is counted once if it contains required items. Each instance of a repeating form that has been started is counted if it contains required items.


Has SV Required Items


Description: The number of possible expected forms across all subjects that contain SV required items.

How calculated: A form is counted if it is possible to be expected or started and contains SV required items. This calculation includes dynamic and repeating forms with SV required items, as follows:

Dynamic forms—A dynamic form is counted if it contains SV required items and is activated or started. Dynamic forms are not counted if they have been removed.

Repeating forms—A repeating form that has not been started is counted once if it contains SV required items. Each instance of a repeating form that has been started is counted if it contains SV required items.



Forms: Form Status Counts Forms: Form Status Count report elements return totals of forms according to their status.

Forms: Form Status Counts Report element Description Form Count Data displayed: Numeric

Description: The total number of forms.

How calculated: This calculation includes all forms, including expected form, forms that have not been started, and unscheduled forms. Use this report element in combination with other predefined filters to narrow report results.



Forms: Form Status Counts Report element Description Expected Data displayed: Numeric

Description: The number of expected forms in the study.

How calculated: A form is counted as expected if it meets any of these criteria:


It appears within a started unscheduled visit It is a dynamic form that has been activated















Forms: Form Status Counts Report element Description Started Data displayed: Numeric

Description: The number of started forms in the study.

How calculated: A form is counted if a user submitted the form or the form has data, a query, or a comment.


Tip: To report on forms that are started but incomplete, subtract the complete count (Complete report element) from the started count (Started report element.)

Missing Required Items


Description: The number of started forms for which at least one required item is empty.

How calculated: A form is counted if it is started, contains required items, and at least one of those items contains no data.


Complete Data displayed: Numeric

Description: The number of forms that have been completed in InForm software.

How calculated: A form is counted as complete if it is expected and meets the following criteria:

It is started All required items contain data No open queries are associated with any items on the form


Frozen Data displayed: Numeric

Description: The number of expected forms that are currently marked frozen in InForm software.

How calculated: A form is counted if it is expected and has been frozen using any of these InForm features:

Freeze CRF Freeze CRB Freeze Visit



Forms: Form Status Counts Report element Description SV Ready Data displayed: Numeric

Description: The number of forms currently marked SV Ready.

How calculated: A form is counted if either of the following is true:

it has been marked SV Ready in InForm software it is included within a casebook that has been marked SV

Ready in InForm software


SV Partial Data displayed: Numeric

Description: The number of forms where source verification is partially complete.

How calculated: A form is counted only if some of the SV-required items on the form are source verified and others are not. InForm software automatically assigns a status of SV partial to any form for which some, but not all, SV-required items have been marked SV complete


SV Complete Data displayed: Numeric

Description: The number of SV complete forms

How calculated: A form is counted if as SV complete in InForm software if all SV required items on the form have been source verified.


Signed Data displayed: Numeric

Description: The number of signed forms.

How calculated: A form is counted if it has been signed in InForm software


Locked Data displayed: Numeric

Description: The number of locked forms.

How calculated: A form is counted if either of the following conditions is true:

it has been locked in InForm software at the form or Visit level

it is contained within a casebook that has been locked in InForm software



Forms: Form Status Counts Report element Description Marked Incomplete Data displayed: Numeric

Description: The number of forms that have been marked incomplete in InForm software.

How calculated: A form is counted if a form comment exists for the form with an Incomplete Reason of Not Done, Not Applicable, or Unknown.


Has Data Data displayed: Numeric

Description: The number of forms on which some data has been entered.

How calculated: A form is counted if data has been entered in at least one item. Note that the item with data need not be a required item.


Has Open Query Data displayed: Numeric

Description: The number of forms with open queries.

How calculated: A form is counted if it contains items that have open queries. This count does not include forms that contain items with queries in states other than open.


Has Answered Query Data displayed: Numeric

Description: The number of forms with answered queries.

How calculated: A form is counted if it contains at least one item with an answered query. This count does not include forms with items that have queries in states other than answered, including closed.


Candidate Query Data displayed: Numeric

Description: The number of candidate queries. Use this report element in conjunction with Form Name to see the number of candidate queries associated with a particular form.

How calculated: A query if it is currently a candidate query.


Open Query Data displayed: Numeric

Description: The number of open queries. Use this report element in conjunction with Form Name to see the number of open queries associated with a particular form.

How calculated: A query is counted if it is currently open. This count includes reissued queries.



Forms: Form Status Counts Report element Description Answered Query Data displayed: Numeric

Description: The number of answered queries. Use this report element in conjunction with Form Name to see the number of answered queries associated with a particular form.

How calculated: A query is counted if it is currently answered.


Has Form Comment Data displayed: Numeric

Description: The number of forms that contain form-level comments.

How calculated: A form is included if it contains at least one form-level comment. This calculation includes forms that have been marked incomplete.

This count does not include forms with only item-level comments.


Has Item Comment Data displayed: Numeric

Description: The number of forms that contain items with item-level comments.

How calculated: A form is counted if it contains at least one item-level comment. This calculation includes items that have been marked incomplete. This calculation does not include forms that include only form-level comments.


Deleted Repeating Data displayed: Numeric

Description: The number of repeating forms that have been deleted.

How calculated: A form is counted if it is a repeating form that has been deleted.



Forms: Form Dates Form Dates report elements allow you to report on dates associated with form status.

About First and Last dates

Forms may be set to some states more than once. For these states, First and Last date report elements appear in the reporting tree. Use these report elements to identify when a form moved from one state to another, as follows:

Use Last dates to determine a form's current status, and the date on which the status change occurred.

Use First and Last dates together to identify forms that had been but are no longer in a given state. You can also use these dates to identify forms that have changed since being set to a given state. For example, you can compare the Data Last Modified Date to the Last SV Complete date to see whether the form was changed since it was marked SV Complete.

Note that if a form has been in a particular state only once, the First and Last dates for that state display the same date.

If a form has never been assigned a particular status, the First and Last dates for that state return null values (resulting columns are empty).

Form Dates Report element Description Current Status Date Data displayed: Date/Time

Description: The date on which the form was assigned to its current state. For instance, if a form's current state is started, this element would return the date on which the form was started.


Data Last Modified Date


Description: The date on which data was last entered or modified on the form.


Form's Scheduled Visit Date


Description: The date on which the scheduled visit containing the form should occur


Form's Visit Data Entry Date


Description: The date on which data was first entered for the visit that contains the form.



Form Dates Report element Description DOV Data displayed: Date/Time

Description: The date entered for the date of the visit that contains the form. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.


Started Date Data displayed: Date/Time

Description: The date on which the form was started.


Complete Date Data displayed: Date/Time

Description: The date on which the form was completed. A form is counted as complete if it is expected and meets the following criteria:



Deleted Date Data displayed: Date/Time

Description: The date on which the form was deleted.


First Frozen Date Data displayed: Date/Time

Description: The date on which the form's status was first set to frozen. A form is frozen if it has been frozen using any of these InForm features:


Note that this report element retrieves only those dates for forms frozen at the form or visit level. It does not retrieve a first frozen date for forms that were frozen at the casebook level.


Last Frozen Date Data displayed: Date/Time

Description: The most recent date on which the form's status was set to frozen.

Note that this report element retrieves only those dates for forms frozen at the form or visit level. It does not retrieve a last frozen date for forms that were frozen at the casebook level.



Form Dates Report element Description First SV Ready Date Data displayed: Date/Time

Description: The date on which the form's status was first considered SV Ready in InForm software. A form's status is SV ready if either of the following conditions are true:

the form was marked SV Ready in InForm software the casebook containing the form was marked SV Ready in

InForm software


Last SV Ready Date Data displayed: Date/Time

Description: The most recent date on which the form's status was set to SV Ready in InForm software.


First SV Partial Date Data displayed: Date/Time

Description: The date on which the forms status was first set to SV Partial. InForm software automatically assigns a status of SV partial to any form for which some, but not all, SV-required items have been marked SV complete.


Last SV Partial Date Data displayed: Date/Time

Description: The date on which the form was last considered SV Partial in InForm software.


First SV Complete Date


Description: The date on which the form was first considered SV Complete in InForm software .A form's status is SV complete if all SV required items on the form have been source verified in InForm software.


Last SV Complete Date


Description: The most recent date on which the form's status was considered SV Complete in InForm software.


First Signed Date Data displayed: Date/Time

Description: The date on which the form was first signed in InForm software.


Last Signed Date Data displayed: Date/Time

Description: The date on which the form was last signed in InForm software.



Form Dates Report element Description First Locked Date Data displayed: Date/Time

Description: The date on which the form was first locked in InForm software.

Note that this report element retrieves only those dates for forms locked at the form or visit level. It does not retrieve a first locked date for forms that were locked at the casebook level.


Last Locked Date Data displayed: Date/Time

Description: The date on which the form was last locked in InForm software.

Note that this report element retrieves only those dates for forms locked at the form or visit level. It does not retrieve a last locked date for forms that were locked at the casebook level.



Forms: Form Status by Month and Year The Form Status by Month and Year report elements let you create reports on form status by month. Use this report elements with form status counts to see the number of forms that were set to a particular status each month.

If the report is sorted by one of the Month/Year report elements, the resulting report displays each month, January 1999 through December 2008. You can then add the Form Count element to see how many forms were assigned a particular status in each month.

The following report shows how many forms were started each month:

Forms: Form Status by Month and Year Report element Description Started Month, Year Data displayed: Date

Description: Each month/year combination, from January 1999 to December 2008. Use this column with Form Count to see how many forms were started each month.


Completed Month, Year


Description: Each month/year combination, from January 1999 to December 2008. Use this report element with Form Count to see how many forms have been completed each month.



Forms: Form Status by Month and Year Report element Description Frozen Month, Year Data displayed: Date/Time

Description: Each month/year combination, from January 1999 to December 2008. Use this report element with Form Count to see how many forms were frozen each month.


SV Complete Month, Year


Description: Each month/year combination, from January 1999 to December 2008. Use this report element with Form Count to see how many forms were source verified each month.


Signed Month, Year Data displayed: Date/Time

Description: Each month/year combination, from January 1999 to December 2008. Use this report element with Form Count to see how many forms were signed each month.


Locked Month, Year Data displayed: Date/Time

Description: Each month/year combination, from January 1999 to December 2008. Use this report element with Form count to see how many forms were locked each month.


Forms: Aging Aging report elements allow you to report on how long forms have been in an incomplete state.

Forms: Aging Report element Description Days Incomplete from DOV


Description: The number of days an incomplete form's status has been incomplete, beginning with the recorded date of visit.

How calculated: This calculation begins on the form's recorded date of visit and ends on the most recent date the form's status was set to incomplete.



Forms: Aging Report element Description Days Incomplete from Started


Description: The number of days an incomplete form's status has been incomplete, beginning with the date on which the form was started.

How calculated: This calculation begins on the date the form was started and ends on the most recent day the form's status was set to incomplete.


Additional information

About DOV controls (on page 15)

Forms: Cycle Times Cycle times report elements let you report on the amount of time it takes for forms to move from one state to another. Note that these elements may return a specific value or an average, depending on other elements used in your report.

Forms: Cycle Times Report element Description DOV to Form Started Data displayed: Numeric

Description: The number of days from the recorded date of visit to when the form was started in InForm software. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.

How calculated: This calculation begins on the recorded date of visit for the form and ends on the day the form's status was set to started.


Started to Complete Data displayed: Numeric

Description: The number of days from when the form was started to when it was completed in InForm software.

How calculated: This calculation begins on the day the form's status was set to started and ends on the most recent day the form's status was set to completed. A form is counted as complete if it is expected and meets the following criteria:




Forms: Cycle Times Report element Description Complete to Frozen Data displayed: Numeric

Description: The number of days from when a form was completed to when it was frozen in InForm software.

How calculated: This calculation begins on the first day the form's status was set to complete and ends on the most recent day the form's status was set to frozen.


Complete to SV Ready Data displayed: Numeric

Description: The number of days from when a form was completed to when it became SV ready in InForm software.

How calculated: This calculation begins on the first day the form's status was set to complete and ends on the most recent day the form's status was set to SV ready.


Complete to SV Complete


Description: The number of days from when a form was completed to when it became SV complete in InForm software.

How calculated: This calculation begins on the first day a form's status is set to completed and ends on the most recent day the form's status was set to SV complete.


Complete to Signed Data displayed: Numeric

Description: The number of days from when a form was completed to when it was signed in InForm software.

How calculated: This calculation begins on the first day the form's status was set to complete and ends on the most recent date the form's status was set to signed.


Signed to SV Complete

Data displays: Numeric

Description: The number of days from when a form was signed to when it became SV complete in InForm software.

How calculated: This calculation begins on the first day the form's status was set to signed and ends on the most recent date the form's status was set to SV complete.


SV Ready to SV Complete


Description: The number of days from when a form became SV ready to when it became SV complete in InForm software.

How calculated: This calculation begins on the first day the form's status was SV ready and ends on the most recent date the form's status was set to SV complete.



Forms: Cycle Times Report element Description Frozen to SV Complete


Description: The number of days from when a form was frozen to when it became SV complete in InForm software.

How calculated: This calculation begins on the first day the form's status was frozen and ends on the most recent date the form's status was set to SV complete.


SV Complete to Signed


Description: The number of days from when a form became SV complete to when it was signed in InForm software.

How calculated: This calculation begins on the first day the form's status was set to SV complete and ends on the most recent date the form was signed.


Signed to Locked Data displayed: Numeric

Description: The number of days from when a form was signed to when it was locked in InForm software.

How calculated: This calculation begins on the first day the form's status was set to signed and ends on the most recent date the form's status was set to locked.


Complete to Locked Data displayed: Numeric

Description: The number of days from when a form was completed to when it was locked in InForm software.

How calculated: This calculation begins on the first day the form became complete and ends on the most recent date the form's status was set to locked.



Section report elements

Forms in your trial may be designed in sections. Section report elements let you report on these form sections in trial design.

Sections Section report elements let you report on sections of forms in your study.

Sections Report element Description Section Title Data displayed: String

Description: The title of a section in a form as entered in the trial design code.



Item report elements

The Items report topic contains elements and measures that provide metrics and status information about items on forms that comprise the study. Use this report topic to include counts of different form types, information about form properties, and information on when items were initially created and changed.

About First and Last dates

Items may be set to some states more than once. For these states, First and Last date report elements appear in the reporting tree. Use these report elements to identify when an item moved from one state to another, as follows:

Use Last dates to determine a item's current status, and the date on which the status change occurred.

Use First and Last dates together to identify items that had been but are no longer in a given state. You can also use these dates to identify items that have changed since being set to a given state. For example, you can compare the Last Modified Date to the Last SV date to see whether the form was changed since it was last source verified.

Note that if an item has been in a particular state only once, the First and Last dates for that state display the same date.

If an item has never been assigned a particular status, the First and Last dates for that state return null values (resulting columns are empty.)

Items Item report elements return metrics on the items in your study.

Items Report element Description Item Name Data displayed: String

Description: The itemset header text, specified in the trial design. Note that access to this data can be restricted in InForm software. When users who have no access to this data run a report with this report element, the resulting report displays a series of asterisks ******** rather than the actual itemset header text.

Note that InForm items that have never had data will not appear on reports that pair Item Name with Form Mnemonic or Form Name.



Items Report element Description Item Question Data displayed: String

Description: Text of the question or prompt that instructs the user to enter specific clinical data. Note that access to this data can be restricted in InForm software. When users who have no access to this data run a report with this report element, the resulting report displays a series of asterisks ******** rather than the actual item question.

Note that InForm items that have never contained data will not appear on reports that pair Item Question with Form Name or Form Mnemonic.


Reason for Change Data displayed: String

Description: Text that explains the reason for the most recent clinical data change (if any) for the item. Note that text appears here only if the item's clinical data has been changed since initial entry.


Incomplete Reason Data displayed: String

Description: Text that explains why the item was marked incomplete. Note that text appears here only if the item has been marked incomplete. Use this report element with Subject Number to see incomplete reason text broken out by subject.


Status Change User Data displayed: String

Description: The username of the InForm user who made the most recent status change to the item in InForm software.


Data Change User Data displayed: String

Description: The username of the InForm user who made the most recent change to clinical data for the item.



Items: Item Properties Item Properties report elements let you report on types of items.

Item Properties Report element Description Is Required Data displayed: Y/N

Description: Indicates whether the item requires a value for the form to be considered data entry complete. Valid values are:

Y: The item is required N: The item is not required

Note: Add Entry items cannot be required.


Is SV Required Data displayed: Y/N

Description: Indicates whether the item requires source verification in InForm software

Y: The item requires InForm source verification N: The item does not require source verification


Items: Item Counts by Property Item Counts by Property report elements let you report item totals based on their design characteristics.

All item counts include only items that have at one time contained clinical data. These counts do not include items for which clinical data has never been entered.

Items: Counts by Property Report element Description Required Data displayed: Numeric

Description: The total number of required items that have ever contained data.

How calculated: An item is counted if both of these conditions are true:

the item is required the item contains (or has ever contained) clinical data



Items: Counts by Property Report element Description SV Required Data displayed: Numeric

Description: The total number of items that require source verification and have ever contained clinical data.


the item is SV-required the item contains (or has ever contained) clinical data


Calculated Data displayed: Numeric

Description: The total number of calculated items, as defined in the trial design.

How calculated An item is counted if:

the item's property is set as a calculated control the item has ever contained clinical data


Items: Item Status Counts Item Status Counts return totals of items (relative to the number of subjects) in various states.

Items: Item Status Counts Report element Description Item Count Data displayed: Numeric

Description: The total number of items, relative to the subjects participating in the study.

How calculated: Each item is counted for each subject if it contains (or ever has contained) clinical data.


Empty Data displayed: Numeric

Description: The total number of items that currently have no data.

How calculated: An item is counted for each subject if both of these conditions is true:

the item currently contains no clinical data the item once contained clinical data



Items: Item Status Counts Report element Description Source Verified Data displayed: Numeric

Description: The total number of items with a current status of source verified.

How calculated: An item is counted if the item its current status is source verified in InForm software.


Marked Incomplete Data displayed: Numeric

Description: The total number of items that are currently marked incomplete in InForm software.

How calculated: This calculation includes items with comments that have an Incomplete Reason of Not Done, Not Applicable, or Unknown.


Deleted Data displayed: Numeric

Description: The total number of items that have been deleted InForm software.

Calculation: An item is counted if it is an add-entry item and has been removed.


Has Item Comment Data displayed: Numeric

Description: The total number of items that have had an item-level comment associated with them in InForm software This calculation includes both:

items with item-level comments (item-level comment is manually entered by user)

items that are marked not done (item-level comment is autogenerated)


Has Query Data displayed: Numeric

Description: The total number of items that have at least one open query associated with them in InForm software.

How calculated: An item is counted if it has at least one open query associated with it. An item is not counted if the only query associated with it is a candidate query.



Items: Item Dates Item Dates report elements let you report on when items were completed and modified.

Items: Item Dates Report element Description Original Value Date Data displayed: Date

Description: The date on which data was originally entered into the item.


Last Modified Date Data displayed: Date

Description: The date on which data was most recently entered into the item.


First SV Date Data displayed: Date

Description: The date on which the item was first source verified.


Last SV Date Data displayed: Date

Description: The most recent date on which the item was source verified.



Rule report elements

Rule report elements and measures allow you to create reports using information about rules attached to the study. Use this report topic to include information about rule types and the number of times rules have been triggered.

Rules Rules report elements return information on rules in your study.

Rules Report element Description Rule Item Refname Data displayed: String

Description: The name that uniquely identifies the item to which the rule is attached in the trial design code.


Rule Refname Data displayed: String

Description: The name that uniquely identifies the rule in the trial design code.


Rule Description Data displayed: String

Description: Description of the rule.



Rules Report element Description Rule Type Data displayed: String

Description: The type of rule. Valid values are:

Server Rule— Executes on the server. Browser Rule— Executes on the browser. Two browser-side

rule activities are supported in InForm software: checks for text entries in a numeric field or numeric entries in an alphabetic field, and smart controls. Smart controls provide automatic selection of radio buttons and check boxes when a user enters or selects a value in an associated text control or list.

Server Calc Rule—Provides the result for a calculated control whose value is based on the value of one or more other items.

Server conversion— Converts units from one standard to another.

Server Rand Rule—Determines the randomized drug kit number to assign in a calculated control.

Clintrialderivation—Is used in a Clintrial study and provides the result for a derived data item whose value is based on the value of one or more other items in the Clintrial database.

Clintrialrule—Is used in a Clintrial study.



Query report elements

Query report elements allow you to include information about the queries that have been issued against clinical data. Use these report elements to see query text and type, to gather counts on manual and automatic queries, and to see query status.

Queries Query report items return identifying information about queries and status.

Queries Report element Description Query Text Data displayed: String

Description: The reason selected or text entered when a query was issued against an item.

If the query state is open, answered, or closed, this element returns the text associated with the last time the query was opened. If the query is a candidate query, this element returns the text associated with the last candidate query.

For automatic queries, query text is defined in the rule that triggers the query. Therefore, query text for automatic queries will be consistent. For manual queries, the query text reflects what an InForm user entered when issuing the query. Therefore, query text for manual queries will vary.

Note that access to item questions can be restricted in InForm. If you do not have access to the item against which the query was issued, this report element returns a series of asterisks********) rather than the query text.


Query Response Data displayed: String

Description: The text of the most recent response to the query. This text is entered when the query is answered. If the query is reopened after it is answered, the resulting column is blank in the report.

Note that access to item questions can be restricted in InForm software. If you do not have access to the item in InForm software, this query element returns a series of asterisks (********) rather than the query response.



Queries Report element Description Query Closure Text Data displayed: String

Description: The text entered when the query was closed.

Note that access to item questions can be restricted in InForm software. If you have no access to the item against which the query was issued, this report element returns a series of asterisks (********) rather than the query closure text.


Query Status Data displayed: String

Description: The current status of the query. Valid values are:

Open Answered Closed Candidate Deleted


Originating User Data displayed: String

Description: The username of the user who first entered the query. If the query has been reissued, this report element returns the username of the user who reissued the query.



Queries: Properties Query Properties report elements let you report on different types of queries.

Queries: Properties Report element Description Query Type Data displayed: String

Description: The type of query. Valid values are:

Automatic—A query generated automatically in InForm software. Automatic queries are triggered by rules in the trial design that check the data as it is entered. If the rule detects a discrepancy in the data, InForm issues an automatic query.

Manual— A query entered by an InForm user. Conflict—A query generated automatically when different

copies of the same trial are synchronized. Conflict queries flag discrepancies that can occur when users are working on two different copies of a trial. Note that this query type exists only when InForm is used with CIS and/or InForm Unplugged.


Is Automatic Data displayed: Y/N

Description: Indicates whether the query was automatically generated by InForm. Valid values are

Y: The query is automatic N: The query is either a manual or conflict query


Is Manual Data displayed: Y/N

Description: Indicates whether the query was entered manually by an InForm user. Valid values are

Y: The query is manual N: The query is either an automatic or a conflict query



Queries: Query Counts Query counts report elements return totals of different types of queries.

Queries: Query Counts Report element Description Query Count Data displayed: Numeric

Description: The number of unique queries, regardless of status or type.

How calculated: All queries that have ever been triggered are counted, regardless of status and type.


Automatic Data displayed: Numeric

Description: The number of queries automatically generated by InForm.

How calculated: All automatic queries that have ever been triggered are counted, regardless of status. An automatic query is a query generated automatically in InForm software. Automatic queries are triggered by rules in the trial design that check the data as it is entered. If the rule detects a discrepancy in the data, InForm issues an automatic query.

This calculation does not include manual or conflict queries.


Manual Data displayed: Numeric

Description: The number of queries entered manually by InForm users.

How calculated: All manual queries that have ever been triggered are counted, regardless of status. A query entered by an InForm user.

This calculation does not include automatic or conflict queries.


Conflict Data displayed: Numeric

Description: The number of conflict queries that have ever been triggered.

How calculated: All conflict queries that have ever been triggered are counted, regardless of status. A conflict query is a query generated automatically when different copies of the same trial are synchronized. Conflict queries flag discrepancies that can occur when users are working on two different copies of a trial. Conflict queries exist only when InForm is used with CIS and/or InForm Unplugged.

This calculation does not include automatic or manual queries.



Queries: Query Counts Report element Description Candidate Data displayed: Numeric

Description: The number of queries with a current status of candidate.

How calculated: All queries with a current status of candidate are counted, regardless of query type.


Open Data displayed: Numeric

Description: The number of queries with a current state of open.

How calculated: All queries with a current status of open are counted, regardless of query type. Note that this total includes queries that have been reissued and are currently open.


Tip: To see the total number of newly opened queries, create a calculation that subtracts the number of reissued queries from the number of open queries.

Resissued Data displayed: Numeric

Description: The number of currently open queries that were reissued.

How calculated: All reissued queries that are currently open are counted. A query is reissued if it has been answered and then re-opened.


Answered Data displayed: Numeric

Description: The number of queries with a current status of answered.

How calculated: All queries with a current status of answered are counted, regardless of query type.


Deleted Data displayed: Numeric

Description: The number of queries with a current status of deleted.

How calculated: All queries with a current status of deleted are counted, regardless of query type.


Closed Data displayed: Numeric

Description: The number of queries with a current status of closed.

How calculated: All queries with a current status of closed are counted, regardless of query type.



Queries: Query Counts Report element Description Status Changes Data displayed: Numeric

Description: The number of state changes for a query.

How calculated: Each status change for each triggered query is counted. This count includes the initial entry of the query.


Queries: Query Dates Query Dates report elements let you report query activity by date. You can also used this information to calculate how long queries have been in a particular state.

Queries: Query Dates Report element Description Query Status Date Data displayed: Date

Description: The date a query was assigned its current status in InForm software.


First Candidate Date Data displayed: Date

Description: The date the query was first issued a candidate status in InForm software.


Last Candidate Date Data displayed: Date

Description: The date the query was last issued a candidate status in InForm software.


Opened Date Data displayed: Date

Description: The date a query was first opened in InForm software.


First Reissued Date Data displayed: Date

Description: The date a query was first reissued in InForm software.



Queries: Query Dates Report element Description Last Reissued Date Data displayed: Date

Description: The date a query was last reissued in InForm software.


First Answered Date Data displayed: Date

Description: The date a query was first answered in InForm software.


Last Answered Date Data displayed: Date

Description: The date a query was last answered in InForm software.


Closed Date Data displayed: Date

Description: The date a query was closed in InForm software.



Query Status by Month, Year The Query Status by Month, Year report elements let you create reports on query status by month. Use this report element with query counts to see the number of queries that were set to a particular status each month.

If the report is sorted by one of the Month/Year report elements, the resulting report displays each month, January1999 through December 2008. You can then add the Query Count element to see how many Queries were assigned a particular status in each month.

The following report shows how many queries were opened each month:

Queries: Query Status by Month, Year Report element Description Query Status, Month, Year


Description: Each month/year combination that has occurred from January 1999 through December 2008. Use this report element with Query Count to see how many queries were opened each month.



Queries: Query Status by Month, Year Report element Description Opened Month, Year Data displayed: Date/Time

Description: Each month/year combination that has occurred from January 1999 through December 2008. Use this report element with Query Count to see how many queries were opened each month.


Answered Month, Year Data displayed: Date/Time

Description: Each month/year combination that has occurred from January 1999 through December 2008. Use this report element with Query Count to see how many queries were answered each month.


Closed Month, Year Data displayed: Date/Time

Description: Each month/year combination that has occurred from January 1999 through December 2008l. Use this report element with Query Count to see how many queries were closed each month.


Queries: Cycle Times Query Cycle Times report elements let you report on how long it takes for queries to move from one state to another.

Queries: Cycle Times Report element Description Days Opened to Answered


Description: The number of days from when a query was first opened to last time it was answered.

How calculated: This calculation begins on the first day a query's status was set to opened and ends on the most recent day the query's status was set to answered. The value returned is either an exact count or an average, depending on other elements in your report. This value encompasses any re-issued and answer cycles that occurred from first open to last answered.



Queries: Cycle Times Report element Description Days Opened to Closed


Description: The number of days from when a query was first opened to last time it was closed.

How calculated: This calculation starts on the first day a query's status was set to open and ends on the most recent date the query's status was set to closed. The value returned is either an exact count or an average, depending on other elements in your report.


Days Answered to Closed


Description: The number of days from when a query was last answered to last time it was closed.

How calculated: This calculation begins on the first day a query's status was set to answered and ends on the last day the query's status was set to closed. The value returned is either an exact count or an average, depending on other elements in your report.


Queries: Aging Queries: Aging report elements let you report how long queries have been in particular states.

Queries: Aging Report element Description Days Candidate Data displayed: Numeric

Description: The number of days a candidate query has been in the candidate state.

How calculated: This calculation applies to only those queries that currently have a status of candidate. The value returned is either an exact count or an average, depending on other elements in your report.



Queries: Aging Report element Description Days Open Data displayed: Numeric

Description: The number of days an open query has been in the open state

.How calculated: This calculation applies only to queries with a current status of open. Note that this value includes reissued queries. The value returned is either an exact count or an average, depending on other elements in your report.


Days Answered Data displayed: Numeric

Description: The number of days an answered query has been in the answered state.

How calculated: This report element returns values only for those queries currently in the answered state. The value returned is either an exact count or an average, depending on other elements in your report.



Comment report elements

Comment report elements allow you to report on comments entered in the course of the study. You can report on both item-level and form-level comments.

Comments Comments report elements allow you to report on form-level and item-level comments recorded in your study.

Comments Report element Description Comment Date Data type: Date

Description: The date the comment was entered in InForm software.

Date type: Entered in InForm software

Comment Text Data type: String

Description: The text entered for the comment. Display of the comment text is limited to 4000 characters.


Comment Type Data type: Text

Description: The type of comment. Valid values are:

Form—The comment is a form-level comment Item—The comment is an item-level comment

Data Source: Derived by InForm Reporting and Analysis (not stored in the Inform Reporting database).Database value decoded for display.

Comment Count Data type: Numeric

Description: The number of comments.

How calculated: All item-level and form-level comments are counted.


Item Count

Data type: Numeric

Description: The number of item-level comments only. Item comments can be entered by an InForm user or automatically generated when an item is marked incomplete.

How calculated: A comment is counted if it is an item-level comment only.

Form-level comments are not counted.



Comments Report element Description Form Count Data type: Numeric

Description: The number of form-level comments only.

How calculated: A comment is counted if it is a form-level comment only. Item-level comments are not counted.



User Info report elements

User Info report elements allow you to gather information on your InForm users. Many of these elements are optional in your trial design; report elements may return blank values.

User Info: Users Users report elements let you report on InForm users.

User Info: Users Report element Description User Name Data displayed: String

Description: The user name of the InForm user.


First Name Data displayed: String

Description: The first name of the InForm user.


Last Name Data displayed: String

Description: The last name of the InForm user.


Title Data displayed: String

Description: The job title of the InForm user.


Description Data displayed: String

Description: Text that describes details of the InForm user. If no description has been entered for the user, the resulting data column is blank.


Rights Group Data displayed: String

Description: The InForm rights group to which the InForm user belongs.



User Info: Users Report element Description Email Data displayed: String

Description: The email address of the InForm user.


Phone Data displayed: String

Description: The phone number of the InForm user.


User Count Data displayed: Numeric

Description: The number of InForm users.


User Type Data displayed: String

Description: The InForm user type. Valid values are:

Site Sponsor System


Creation Date Data displayed: Date/Time

Description: The date the user record was created in the InForm system.


Activation Date Data displayed: Date/Time

Description: The date the user was activated in the InForm system.


User Status Data displayed: String

Description: The current status of the InForm user. Valid values are:

Active Inactive Terminated


User Status Date Data displayed: String

Description: The date when the InForm user was assigned his or her current status.



User Info: Group Associations Group Associations report elements let you report on the InForm groups with which users are associated.

User Info: Group associations Report element Description Group Name Data displayed: String

Description: The name of a group with which the InForm user is associated.


Group Type Data displayed: String

Description: The type of the group with which the InForm user is associated. Valid values are:

Rights Query Signature Reporting Reportlist Site Manage User



Predefined filters

Use these predefined filters to narrow results in your ad hoc reports. These filters are shipped with InForm software and can be used across all reports.

You can also create filters to be used within reports. Keep in mind that filters you create in reports cannot be used globally across multiple reports; each user-created filter is saved with the report in which it was created and can be used only with that report.

Filters Predefined filters let you limit your report to specific subjects, visits, and forms.

Predefined Filters Filter Description All Enrolled Subjects Limits the report to data about only those subjects who have been

enrolled in the study through InForm software. When this filter is applied, the resulting report includes all active subjects who were ever enrolled. The resulting report includes data for subjects in any of these states:

Enrolled Enroll Override Randomized Dropped Out Complete

All Enrolled Subjects except Dropped

Limits the report to data about only those subjects who were ever enrolled in the study through InForm software, excluding those subjects who dropped out. The resulting report includes data about subjects in any of these states:

Enrolled Enroll Override Randomized Complete

Active Subjects Limits the report to data about only active subjects; that is, all subjects who have been enrolled in the study through InForm software, excluding those who have dropped out or completed the study (Dropped out and completed states are set when the Study Completion form is completed for a subject).

The resulting report includes data about subjects in any of these states:

Enrolled Enroll Override Randomized


Predefined Filters Filter Description Clinical Visit Limits the report to data about only clinical, or subject visits. Use

this filter when you want your report include information only about clinical visits. This filter excludes data for these visit types:

Screening Enrollment Reg Docs Visit Report

Clinical Form Limits the report to information clinical forms (forms whose type is CRF). This filter excludes these types of forms:

Enrollment Monitor RegDoc Monitor Visit Report

Expected Forms: Scheduled Visits

Limits the report to those clinical forms that are expected because they appear in scheduled visits.

Expected Forms: Scheduled or Started Visits

Limits the report to expected forms that are expected because they appear in scheduled or started visits.

Expected Forms: Scheduled or Started Visits to Date

Limits the report to forms that are expected because they appear in visits that are scheduled to occur or have started by a particular date (This filter prompts the report user to enter a date).

Expected Forms: Scheduled Visits or Started Forms to Date

Limits the report to forms that have started by a given date or are expected because they appear in visits that are scheduled to occur by a given date. (This filter prompts the report user to enter a date.)

Data Complete (Queries Allowed)

Limits the report to forms that are data complete; that is, forms for which all required items have been completed. Note that this filter does not exclude forms that have queries (in any state) associated with them.

Data Complete, No Open Queries

Limits the report to data for forms that are data complete; that is, forms for which all required items have been completed. This filter excludes forms that have open and candidate queries associated with them. Note that this is comparable to a green traffic light in InForm.

Data Clean: Complete and SV

Limits the report to forms that are data complete and clean. This filter includes forms for which:

all required items have been completed all SV Required items have been source verified using

InForm software.

The filter excludes forms with open and answered queries associated with them.

115

InForm Ad Hoc Reporting allows you to create reports that contain trial management data and clinical data. While the trial management portion of the model allows you to create reports on the progress of your trial, the clinical portion of the reporting tree allows you to create reports that display values entered into the clinical forms of your InForm study.

Your InForm rights group controls your view of the InForm Ad Hoc Reporting tree. Depending on your login rights, you may or may not be able to see clinical reporting elements in Ad Hoc Reporting.

In This Chapter About the clinical reporting tree....................................116 About reporting on clinical data....................................118 Creating reports with both clinical and trial management data ......................................................119 How clinical data is represented in the Ad Hoc Reporting tree................................................120 Reporting on multi-instance forms and visits ...............142

C H A P T E R 5

Reporting on clinical data


About the clinical reporting tree

The clinical portion of the Ad Hoc Reporting tree is built from the structure of the reporting database; reporting topics and elements are included for each form and control stored in the reporting database. The database structure is dependent on the trial design.

The clinical portion of the reporting tree resides in the Clinical Data by Folder. The following image illustrates the structure of the Clinical Data by Form folder:

Clinical form reporting topics—Each reporting topic corresponds to a form or an itemset within your study.

Report element folders—Clinical reporting elements are organized in four folders, described in the following table:

Default Folder name

Description

Basic Data Contains clinical report elements that return clinical values associated with the form. The basic data folder contains display textual values of items rather than database codes as well as most of the available date formats.

This folder also contains several reporting elements you can use to identify site, subject, and visit (these elements also appear in the Trial Management portion of the reporting tree.)

The Basic Data folder is designed to provide easy access to meaningful reports. You can select the entire folder to create a basic report for a given form that includes:

easy-to read, meaningful data appropriate key elements to ensure report accuracy

Chapter 5 Reporting on clinical data 117

Default Folder name

Description

Additional Data Contains report elements available for more advanced reports. Some of the elements included here return database codes, rather than textual values for fields, normalized values, and unit codes.

Incomplete Data Reason

Contains reporting elements that return textual explanations of why an item on a form is not complete.

Internal IDs Contains reporting elements that return values that uniquely identify a record in the database.

Clinical report elements—Clinical report elements reflect the item questions that appear on the forms within your study. Labels for reporting elements may or may not have been customized for display in the reporting tree.

Trial management report elements—To create reports with clinical data, you must be sure to include elements that identify the study component (subject, visit, and so forth) on which you want to report. The Clinical Data by Form folder contains some report elements from the Trial Management package; you can use these elements to identify visit, subject, and site in your clinical reports, and to identify unique instances of repeating visits, forms, or itemsets,

When the clinical package is originally generated, the labels of each reporting element match the labels used within the trial design. Report topics are placed within default folders (Basic Data, Additional Data, Incomplete Data Reason, and Internal IDs.)

Keep in mind that labels and folder location for elements can both be customized; this document describes label naming conventions and element folder locations. Your clinical model labels and folders may vary.


About reporting on clinical data

When you create reports using clinical data, keep the following things in mind:

Available clinical data and clinical data organization are unique to each trial; for this reason, reports that contain clinical data may not be validated to use across trials.

Data entered in clinical forms can be changed several times during the course of a study. Though InForm captures audit trail data and stores it in the InForm reporting database, the clinical data elements available in the Ad Hoc Reporting tree return only the most current values for any controls in clinical forms.

A trial is likely to go through many study versions; that is, forms and items may be added to or deleted from the original study design. Note that the Clinical Data by Form folder contains data elements for every form and item that have ever been used in any version of the study.

You can use Ad Hoc Reporting to see clinical data for only those subjects in sites with which you are affiliated in InForm software.

Just as your InForm rights group controls your access to specific pieces of data in InForm software, your rights also determine which reporting elements are visible to you in Ad Hoc Reporting. For instance, if you are not allowed to see certain items in InForm, you will not be able to access data for those items in reports.

When creating reports using clinical data, you must be sure to include a unique identifier for the study component on which you want to report. For example, to create a clinical report about a particular subject, you must use whatever identifiers uniquely identify the subject in your study. Depending on your study design, you may use: Subject Number, if unique Subject Numbers are assigned for your

trial

Subject Number and Subject Initials, if unique Subject Numbers are not assigned for your trial

the SubjectID internal ID


Creating reports with both clinical and trial management data

You can create reports using elements from both the clinical portion and the trial management portion of the reporting tree. Keep the following restrictions in mind:

You must include data from only one clinical form in any report that combines both clinical and trial-management data.

You should not use elements from these trial management report topics in reports that also contain clinical elements: Sections

Items

Rules

Queries

Comments

Report results will be difficult to interpret if you choose to include these report elements.


How clinical data is represented in the Ad Hoc Reporting tree

This section explains how different study components are represented in the Clinical Data by Form folder.

Understanding default labeling Default labels for clinical report elements come from properties that are established in the trial design code; that is, when your trial was created with InForm Architect, trial designers specified different pieces of information to identify each form, itemset, or control in your trial. InForm retrieves the text entered into these properties and uses them for default labeling of the clinical report elements.

InForm creates default labels for elements that appear in the Clinical Data by Forms folder as follows:

optional prefix~ ~ control reference~ item reference

The following table describes each portion of the default label.

Report element label portion

Description

optional prefix Defines the type of element. Possible prefixes are:

None Code Unit Unit Code Normalized Date Time Month Yr YYYY/MM/DD HH24:MM:SS Month Year


Report element label portion

Description

control reference Text that identifies the specific control for the item

If the control is NOT a checkbox control, InForm uses text entered in these properties for the second part of the control reference:

Caption property for the control, if it exists RefName property for the control, if no caption

exists

If the control is a checkbox, InForm uses text entered into these properties for this portion of the report element label:

Label property of the child control element, if it exists

Caption property of the child control element, if no Label exists

RefName property for the child control element, if no Label or Caption exist.

item reference Text that identifies the item, as it appears in the trial. InForm uses text entered into these properties for this portion of the report element label:

Itemset Column Header property for the item, if it exists and is not the default.

Question property for the item, if no Itemset Column Header exists

Trial designers should ensure Itemset Column Header definitions are unique within a study. If they do not and InForm Reporting and Analysis finds duplicate Itemset Column Header values, it combines the items into one row in reports.


About clinical report topics: forms and add-entry forms (itemsets) When the clinical portion of the InForm Reporting Database is generated, database views are created for each form and Add Entry form (itemset) in your study. When the clinical reporting package is generated, each of these database views is represented as a report topic.

Each report topic that appears in the Clinical Data by Form folder corresponds to either a form in your study, or an itemset on a form.

Alternate forms are also represented by a report topic.

Report topics are labeled with an appropriate suffix (Form or Itemset). In addition, The labels for Itemset report topics begin with a prefix that identifies the form on which they appear.

Representation in the clinical reporting tree

This image illustrates the Forms and Itemset suffix, used to identify forms and itemsets in the clinical reporting tree:


About code report elements Some clinical data is represented both by a textual value and a code in the reporting database. For example, a Yes answer to a question on a form is stored both as a Yes and as a 1 in the database. By storing data in this way, InForm ensures that there is a unique, audited data record for the data (code), while also allowing a more readable display value (text), that can be adjusted if necessary, to be more understandable by users.

Clinical report elements appear in the tree that give you the option of including either (or both) the textual answer to a question or the code values in your reports. (Text values are the more readable format in a report, and are therefore included in the Basic Data folder for easy access.) By default, the labels for report elements that return code values begin with the prefix Code~ and appear in the Additional Data folder for any form in the reporting tree.

The labels and folders discussed here are defaults only; your organization may customize the clinical reporting tree, and therefore, your report subjects and elements may be labeled differently, and may appear in different folders.

Control in InForm software

The following image illustrates a portion of a form in InForm software:



The first image below illustrates some of the report elements in the Basic Data folder for a form that gathers physical examination data. The Cardiovascular report element returns a textual answer for the Cardiovascular item question:

The next image illustrates the report element for the same Cardiovascular form question as it appears in the Additional Data folder. This report element is prefixed with the word Code~; this element returns database codes for each form question.


Resulting report

About data that require units of measure Some answers to form questions are qualified by a unit of measurement. For instance, a subject's weight may be measured in kilograms or pounds.

For each question that requires a unit of measure qualifier, four report elements appear in the reporting tree, as follows:

Report element (Default label)

Description Default folder

<control reference>

Example: Weight

Returns the value entered during data entry. For instance, if the InForm user entered 135 on the form, the Weight element would return 135.

Basic Data

Unit~ <control reference>

Example Unit~ Weight

Returns the specific unit of measure selected at data entry. The label for this element has the prefix Unit ~. For instance, the Unit ~ Weight it element might return these values: kg or lbs.

Basic Data

Normalized~ <control reference)

Example: Normalized~ Weight

Returns the normalized value; InForm converts measurements to the same, or normalized, unit of measure, based on a base unit of measure defined for your study. For instance, if the base unit of measure is kilograms, InForm converts all values entered to kilograms and stores that value as a normalized value.

Additional Data




Unit Code~ <control reference>

Example: Unit Code ~Weight

Returns the code value for the unit of measure, as it is stored in the database. The label for this element has the prefix Unit Code.

Additional Data

Control in InForm software



The first image below illustrates some of the report elements in the Basic Data folder for a form that gathers vital signs data. This folder contains the vsweight and Unit ~ vsweight report elements:

The next image illustrates the report elements for the same Weight form question as it appears in the Additional Data folder. This folder contains the Unit Code ~ weight and Normalized ~ weight report elements:


Resulting ad hoc report

This report shows the different values returned by the Weight, Unit ~ vsweight, Normalized ~ vsweight, and Unit Code ~ vsweight report elements:

About itemsets, repeating visits, and repeating forms Itemsets and repeating forms may capture data multiple times for a given subject. Forms may also appear in repeating visits. You can report on data collected at different iterations of itemsets, repeating forms, and repeating visits using index elements from the clinical reporting tree to identify specific itemset, form, and visit instances.

The Internal IDs folders also contain these report elements: FORMINDEX, ITEMSETINDEX, and VISITIINDEX. While these elements also identify specific instances of repeating forms, visits, or items, they return the actual database value assigned to these instances.

The Form Index, Itemset Index, and Visit Index elements that appear in the clinical model return ordinal values for these instances, derived for display. For instance, a Form Index report element from the clinical tree may return 1, 2, and 3 to identify the first, second, and third instances of a form.


Form Index

The report topic for any repeating form contains a Form Index report element. Use this element to separate data gathered at each instance of the repeating form.



Form index Returns a numeric value that indicates each instance of a repeating form.

Basic Data


This screen shows the Form Index element for the Concomitant Medication form, which is a repeating form.



This report shows how you can use the Form Index to see data entered in each instance of the repeating form.

Note subject 02-003. This report shows that 3repeating forms were entered for the subject, with the corresponding 3 medications being taken.

Visit Index

The report topic for any form or itemset that appears within a repeating (unscheduled) visit contains a Visit Index report element. Use this element to identify the visit instance in which data was gathered.



Visit Index Returns a numeric value that indicates the instance of the visit in which data was entered for the form.

Basic Data



This image shows the Visit Index element for the Electrocardiogram form, which appears in a repeating visit in InForm software:



This report shows how you can use the Visit Index to see data entered for the form in each instance of the visit.

Itemset Index

The report topic for any Add Entry form contains an itemset Index report element. Use this element to separate data gathered at each instance of the itemset.



Itemset Index Returns a numeric value that indicates each iteration of an itemset.

Basic Data



This screen shows the Itemset Index element for the Dosing Record itemset:


This report shows how you can use the Itemset Index to see data entered in each instance of the item.


About deleted itemsets and form instances InForm users can mark for deletion both itemsets and instances of repeating forms. (By marking a form or itemset for deletion, InForm removes the form or itemset from the casebook, but keeps record of the form or itemset in the database.)The clinical reporting tree allows you to report on itemset and form instances that have been marked for deletion.

The report topic for any itemset or repeating form instance contains an element that returns data on whether the form or itemset was deleted in InForm software:



Deleted Form Indicates whether the reported form instance was marked for deletion in InForm software. Use this report element with the Form Index element to see form instances that have been deleted. Values are:

Y—Form was marked for deletion

N—Form was not marked for deletion

Basic Data

Deleted Itemset Indicates whether the reported itemset was marked for deletion in InForm software. Use this report element with the Itemset Index to see itemsets that have been deleted. Values are:

Y—Itemset was marked for deletion

N—Itemset was not marked for deletion

Basic Data


When creating reports on forms and itemsets, you may want to include these report elements to identify instances that have been marked for deletion.


This image illustrates the Deleted Form report element for the Concomitant Medication form, which is a repeating form:

This image illustrated the Deleted Itemset report element for the Dosing Record itemset:



This report shows how you can use the Deleted Form and Form Index to determine which instances of the form may have been deleted:

.

This report shows how you can use the Deleted Itemset and Itemset Index to determine which instances of the itemset may have been deleted.


About date controls Date controls used throughout your study are represented different ways in the clinical reporting tree.

In study design, some dates are captured as true dates; some are captured as string values. Note that display of true dates in reporting is subject to date format specified in Cognos.

Depending on details embedded in your study design, your clinical reporting tree may contain any of the following date report elements:



Date ~ <control label>

Example Date~ Start Date

Returns a date, including Month, Day, and Year.

Returns a blank value if any portion of the date contains no data, or for which UnKnown has been chosen in InForm software.

Basic Data

Month Yr ~ <control label>

Example: Month Yr ~ Start Date

Returns a date, including Month and Year.

Returns a blank value if any portion of the date contains no data, or for which Unknown has been chosen in InForm software.

Basic Data




YYYYMMDD ~ <control label>

Example: YYYMMDD ~ Date Started

Returns a text string in YYYYMMDD format.

Data displays here when a date control allows unfilled or unknown values.

Basic Data

Time ~ <control label>

Example: Time ~ Date Taken

Returns a standard time (24-hour clock) in HH:MM:SS format.

Returns a blank value if any portion of the time that contains no data, or for which Unknown has been chosen in InForm software.

Note that this report element appears only for those InForm controls that collect the time portion of a date.

Basic Data

HH24:MM:SS ~ <control label>

Example: HH24:MM:SS~ Date Taken

Returns a textual time (24-hour clock)

Data displays here when a date control allows unfilled or unknown values.

Note that this report element appears only for those InForm controls that collect the time portion of a date.

Basic Data

Year ~ <control label>

Example: Year ~ Date Taken

Returns only the Year portion of a date.

Returns a NULL value if no Year has been entered in InForm software.

Additional Data

Month ~ <control label>

Example: Month ~ Date Taken

Returns only the Month portion of a date.

Returns a NULL value for any portion of this data that contains no data, or for which Unknown has been chosen in InForm software.

Additional Data


Control in InForm

The following image illustrates a portion of a clinical form in InForm software:


This image shows the different date report elements you can use to report on the date of visit specified in the Physical Examination form:



This image shows the different values returned by the Date ~ and Month Yr~, date report elements:

About Incomplete Data Reasons Each clinical report topic contains an Incomplete Data Reasons folder. Report elements that appear here return textual values that explain why an item question is marked incomplete.


This image shows the different date report elements you can use to report on the date of visit specified in the Concomitant Medications form:



This image shows the an ad hoc report that shows Incomplete Data Reasons for the Unit Dose item on the Concomitant Medications form.


Reporting on multi-instance forms and visits

Your trial may include any number of the multi-instance forms or items, including:

repeating forms non-repeating forms that occur within repeating visits add-entry forms (also called itemsets)

When creating ad hoc reports, you can include data from more than one of these multi-instance forms, items, or visits on the same report.

However, keep in mind that such reports cannot show a relationship between individual instances of multi-instance forms and items, since no relationship exists.

Consider the following example:


This report accurately provides data on both the adverse events and concomitant medications for each subject. It accurately illustrates the relationships between:

The subject and each adverse event The subject and each medication

There is, however, no predictable relationship between different instances of multi-instance forms. Therefore, there is no implied relationship between each adverse event and each medication listed.

Filtering reports with more than one multi-instance form or itemset

You can apply filters to reports that contain data from more than one multi-instance form. However, results will vary depending on where you apply the filter. The table below describes how reporting behavior differs, depending on the filtered element:

Reports containing data from more than one multi-instance form or itemset You can filter on.. ..and yield these results: A report element from a single-instance form

Rows for filtered-out items are removed.

Example: Report contains: SubjectID, Gender, Adverse events, and Concomitant Medications

Filter: Gender column = Male

Results: Report removes all rows for female subjects.

A report element from a multi-instance form

Rows for filtered-out items are not removed (they are set to blank values.)

Example: Report contains: SubjectID, Gender, Adverse events, and Concomitant Medications

Filter: Adverse event = Depression

Results: Report does not remove rows for other adverse events. Instead, the Adverse Events column displays blank values for all other adverse events.

145

InForm software includes a set of management reports that provide information about the progress of a study These reports show several categories of information, described in the sections that follow. Several views of each report are available; for example, you can display the Subject Status reports by site and by user, month-by-month or trial-to-date, and in text or graphical formats.

In This Chapter What makes up a standard report?..............................146 About data in Standard Reports...................................152 Report folders...............................................................153

C H A P T E R 6

InForm Standard Reports


What makes up a standard report?

Three types of pages comprise each standard report:

Report prompt page Report/Graph page Summary page

About the report prompt page The report prompt page is where you select criteria and choose sort options for your report. A typical report prompt page appears below:

Prompt pages are made up of three sections:

Selection criteria Sort options Run report/More options/Cancel buttons

.

Chapter 6 InForm Standard Reports 147

Selection criteria

The selection criteria portion of the prompt page allows you to narrow criteria used to run your report. This portion of the screen may contain:

Cascading prompts Checkboxes Drop-down lists

Cascading prompts

Cascading prompts allow you to select criteria in one category to narrow the selections offered in another category.

In the example below, the Countries and Sites list boxes are cascading prompts. You can select one or more countries from the list and click Update to see only sites for selected countries in the SItes list.


You can select one or more items in any of these list boxes to limit your report to your selections.

You can also choose to make no selection. However, making no selection means no criteria will be applied for this prompt to limit the reported data. This often will run a report faster than explicitly selecting all values in the prompt list.

If you change a selection in one prompt, be sure to click Update to update all cascading prompts.

Note also that some reports require you to make some selection before you can run the report. In these cases, the Run Report button is grayed out, and red dashes indicate the field in which you must make a selection.

Checkboxes

Checkboxes allow you to select one or several options for narrowing report criteria.

You can select one or more checkbox items to limit your report to your selections.

For some checkboxes, data must meet criteria for all option selections to be contained in the report. For other checkboxes, data must meet criteria for at least one of the options selected to be contained in the report.

Drop-down lists

Drop-down lists let you choose only one option. To choose one option, click the arrow on the drop-down list and move the cursor to the correct selection.


Sort options

The Sort Options portion of the prompt page lets you choose up to 3 columns on which to sort a report.

Drop-down lists appear at the bottom of each report prompt page. Default sorting selections are automatically selected. You can change these to create your own report definition.

Beneath each sort drop-down list are radio buttons labeled Ascending and Descending. Ascending sorts are automatically selected by default. Use the radio buttons to change the sort type.

Reports that include groupings, such as by user and by site, are sorted at the detail level within the grouping, according to the selections made in the drop-down lists. The grouping ort order can be modified (ascending vs. descending) but will always be the primary sort column.

Run Report/More Options/Cancel buttons

The bottom left of each prompt page contains buttons you can use to:

run the report see more options (if available) cancel the report


About the Report/Graph page The Report/Graph page displays the results of your report, based on the criteria you selected in the Prompt page.

The Report/Graph page can be made up of three parts:

Show/Hide Report Selections (if applicable) Graphs, list, or crosstabs Report footer

Show/Hide Report Selections

A Show/Hide Selections link appears for all reports. Clicking this link lets you toggle on and off a list of the selection chosen on the prompt page. Clicking this link also lets you change the sort selections for the report.

Graphs and columns

Metrics/performance standard reports include Graphs that graphically represent the report results. When a chart is included in a report, it appears on the first page. Use the Page Down link to move down to the report columns.

Below is a sample chart, included in the CRF Site Performance Summary by Site report.


Report columns display data returned when the report is run. Some columns include totals and subtotals. Below is an illustration of the columns on Subject Counts with Outstanding Queries report:

Report header

The report header displays the report title and study name. The header may also optionally display a logo.

Report footer

The report footer contains this data:

Footer label Description Run at The date and time the report was run

Page Page number appears centered in the footer, as follows:

In HTML versions of reports, the page number displays In PDF versions of reports, the page number and total

page count displays.

Data as of The date and time that data was last replicated to the InForm Reporting database.

About the Summary page The summary page summarizes user selections from the report prompt page. Click the Bottom link on any report to see the summary page. This information is included for report printouts so readers will know what criteria were used.


About data in Standard Reports

Keep these things in mind when you run standard reports:

Standard reports display subtotal and totals for numeric columns. However, InForm Reporting and Analysis cannot calculate subtotals and totals for columns that display a median value. For reports that include median calculations, subtotals and totals are blank.

Standard reports show data for only clinical visits and clinical form types. All by User reports in InForm are designed to provide information on the

performance of monitors who are designated as primary for your study. They are provided to get performance statistics about all roles within a trial. Where more than one person within a given role, such as CRA, may be associated with the same site, you will see the same data multiple times, one row for each person. You can limit this by selecting specific individual users, such as primary CRAs, or establishing special rights groups that ensure no duplication by site. To get the most out of these reports, follow these guidelines: Understand the Rights Group organization for your study and how

primary monitors fit into this organization. All primary monitors may be assigned to a single rights group; or they may be scattered among several. Knowing which rights groups to select is the first step in filtering the report to target only primary monitors (Selecting all rights groups is likely to result in an unwieldy report.)

Know how to identify your primary monitors. This is especially important if your organization has not designated a single rights group for all primary monitors.

If you are able to easily identify key Rights Groups and Users, the by User reports will be manageable and will yield reliable results.


Report folders

All of the standard reports included with InForm appear on the Public folders tab of the InForm Reporting and Analysis portal. The following image shows the list view of the Public Folders tab:


Standard reports are organized into four folders:

CRF reports Item reports Query reports Subject reports

Click each folder name to access a complete list of standard reports for the chosen category. The image below shows the list view of the CRF Reports folder.

To run the report you can:

Click the link for the report. Right-click the link for the report, to run the report in a separate window.

This option is helpful when you are running drill-through or drill-down reports.

Click the Run Report with Options icon.

Tip: You can toggle between a list view and a detail view of the standard reports folders. On the InForm Navigation pane, select Help-> Using ReportNet Tools for more information.

About report actions Each standard report folder lists Report Action icons. In list view, these icons appear under the label Report Actions:


In details view, these icons appear under the report name and last run time information:

Click More in either view to see a complete list of report actions. The following table provides brief descriptions of each of these actions.

Report action Description Set properties Allows you to specify such items as report name, and

screen tip for the report.

View most recent report in HTML

Displays the latest saved HTML view of the latest version of the report. If you click this link, the report will run based on the last saved prompt values specified for the report.

View report output versions

Displays a list of all output versions created for the report, if report views have been saved. You can click these links to see each version. If you click this link, the report will run based on the last saved prompt values specified for the report.

Run with options Lets you specify output version and delivery mechanism when you run the report. Use this option to change any prompt values that may have been previously set for the report. (Note: This release of InForm does not support selecting a language other than English.)

New schedule Allows you to schedule the report.

Note: Only users with Publisher rights or Report Administrator rights can access this option.

View run history Allows you to see the request time, start time, and completion time for each time the report was run.


Move Allows you to move the report to another folder.


Copy Allows you to copy the report to another folder.


Create shortcut to this entry

Allows you to create a shortcut to this report. You can specify any folder location (to which you have write access) for the shortcut.


Create report view of this report

Allows you to create a report view of the report.


Delete Allows you to delete the report.



For more information

Complete information on Cognos ReportNet features appears in the ReportNet documentation. You should use the Cognos documentation set for complete information on creating, running, saving, and scheduling reports You should also use Cognos documentation for information on Cognos Report Studio, if you have licensed that application.




Running reports with options The Run Reports with Options icon ensures you will be able to select criteria and sort options on the report prompt page. Therefore, the procedures included in this section direct you to run the report with options.

157

CRF reports provide information about the progress of data entry and query activity on Case Books that have been started.

In This Chapter CRF Aging by Site report .............................................158 CRF Aging by User report ............................................163 CRF Cycle Time Detail by Site.....................................168 CRF Cycle Time Detail by User ...................................173 CRF Site Performance Summary by Site.....................179 CRF Site Performance Summary by User ...................184 CRF Status Detail by Site and Subject ........................189 CRF Status Detail by Visit and Site..............................196 CRF Status Summary by Site ......................................203 CRF Status Summary by User.....................................210

C H A P T E R 7

Case Report Form (CRF) reports


CRF Aging by Site report

The CRF Aging by Site report shows how many forms are expected at any point in the trial as well as how many are incomplete. They also show how long incomplete forms have been incomplete beginning with the date of visit. (Note this calculation relies on the use of specified DOV elements in the form design. See About DOV controls (on page 15) for more information.)

Selection criteria: CRF Aging by Site prompt page Use the CRF Aging by Site prompt page to select criteria and specify sort options for your report.

See How to run a report (on page 20) for general instructions on running InForm reports.

CRF Aging by Site Selection criteria Action Countries Choose one of these actions:

Select one or more countries from the list to report on specific countries. Click Update after your selection to update the Sites list

Make no selection to include all countries in your report.

Sites If you updated the Sites list after selecting one or more countries, choose one of these actions:

Select one or more sites from the list to report on specific sites. Click Update after your selection to update the Subjects list with Subject IDs.

Make no selection to include all listed sites in your report.

Expected forms for Filter the report by expected forms. Choose one of these options from the drop-down list.

All forms—Includes only clinical forms (forms whose type is CRF).

Scheduled visits—Includes only clinical forms that are expected because they appear in scheduled visits.

Scheduled or started visits—Includes only clinical forms that are expected because they appear in scheduled or started visits.

Scheduled or started visits to date—Includes only clinical forms that are expected because they appear in visits that are scheduled to start or have been started by the date the report is run.

Scheduled visits or started forms to date—Includes only clinical forms that are expected because they either: appear in visits that are scheduled to occur by the

date the report is run. have been started by the date the report is run.

Chapter 7 Case Report Form (CRF) reports 159

CRF Aging by Site Selection criteria Action Aging Interval Enter a time duration (in days) to be used as the aging

interval. The resulting report uses the aging interval to show how many forms have been incomplete during specific ranges of calendar days after the date of visit.

For instance, if you specify 7 here, the resulting report shows the number of forms that have been incomplete for:

7 or fewer days after the date of visit more than 7 days but fewer than 14 days after the DOV more than 14 days but fewer than 28 days after the DOV more than 28 days after the DOV

Limit to forms with Select one or more options to filter the report to include only forms with:

Required items SV required items Outstanding queries Comments

Note that the resulting report will include all forms selected here.

If you leave all checkboxes blank, the report includes all applicable forms.

Sort options

CRF Aging by Site Sort Default selection First level sort: Country

Second level sort: Site Mnemonic

Third level sort: None


Report/Graph page: CRF Aging by Site This section describes the report/graph pages for the Case Book Completion and Query Summary by Site report.

Subtotals and totals Subtotals—by Country Totals—overall form count totals

CRF Aging by Site Column Description Country Data displayed: String






Subject Count Data displayed: Numeric

Description: The number of subjects enrolled in the study.

How calculated: For each site, all subjects, regardless of status, are included in this count. This count includes all screened, enrolled, randomized, dropped, and completed subjects, as well as subjects who have been through the enroll override process.



CRF Aging by Site Column Description Form Counts: Expected



How calculated: This number reflects the number of expected forms based on the Expected forms for filter selected on the prompt page for this report. These filters are:

All forms—Includes only clinical forms (forms with a type of CRF).



Scheduled or started visits to date—Includes only clinical forms that are expected because they appear in visits that are scheduled to start by the date the report is run and forms that have been started.

Scheduled visits or started forms to date—Includes only clinical forms that are expected because either of the following is true:

they appear in visits that are scheduled to occur by the date the report is run

they have been started Data Source: Derived by InForm Reporting and Analysis (not stored in the Inform Reporting database).

Form Counts: Complete






Form Counts: Incomplete


Description: The number of expected forms that are started but not complete.

How calculated: For each site, this calculation is:

<started form count> - <complete form count>



CRF Aging by Site Column Description Form Counts: Not Started

Data displayed: Numeric/Percentage

Description: The number of expected forms that are not started in InForm software.

How calculated: This value is calculated based on the Expected forms form filter selected on the report prompt page. InForm calculates the not started forms by taking the total number of expected forms based on the filter you select, and then subtracts from that number all forms that have been started.

A form has a started status if a user submitted the form or the form has data, a query, or a comment. This value displays as a whole number and as the percentage of expected forms that are not started:

<% not started> = <not started form count> * 100 /<expected form count>


Incomplete (from DOV) Form Counts:


Description: The number of forms that have been incomplete for specific ranges of calendar days after the date of visit. You specify the aging interval (in days) on the report prompt page.

Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.

For instance, if you specify 7 on the report filter page, the resulting report shows the number of forms that have been incomplete for:

7 or fewer days after the date of visit more than 7 days and less than 14 days after the DOV more than 14 days and less than 28 days after the DOV more than 28 days after the DOV

How calculated: This value is displays as a whole number, followed by a percentage of the total incomplete form count. The percentage is calculated as follows:

<incomplete form count within the aging interval> * 100 / <incomplete form count>



CRF Aging by User report

The CRF Aging by User report shows how many forms are expected at any point in the trial as well as how many are incomplete. They also show how long incomplete forms have been incomplete beginning with the date of visit. (Note this calculation relies on the use of specified DOV elements in the form design. See About DOV controls (on page 15) for more information.)

User reports can return a large amount of data. User reports will be more manageable if you select one rights group, or a set of specific users, such as primary CRAs, for each report.

Selection criteria: CRF Aging by User prompt page Use the CRF Aging by User prompt page to select criteria and specify sort options for your report.


CRF Aging by User Selection criteria Action Rights Groups Select the rights group or groups used for CRAs that are

primary in your study. Click Update after your selection to update the Users list.

Users Select one primary user from each selected rights group. Click Update after your selection to update the Sites list.

Sites If you updated the Sites list, choose one of these actions:

Select one or more sites from the list to report on specific sites.

Make no selection to include all sites in your report.


CRF Aging by User Selection criteria Action Expected forms for: Filter the report by expected forms. Choose one of these

options from the drop-down list.





Scheduled visits or started forms to date—Includes only clinical forms that are expected because either of the following is true: they appear in visits that are scheduled to occur by

the date the report is run they have been started by the date the report is run

Aging interval Enter a time duration (in days) to be used as the aging interval. The resulting report uses the aging interval to show how many forms have been incomplete during specific ranges of calendar days after the date of visit.


7 or fewer days after the date of visit more than 7 days but fewer than 14 days after the DOV more than 14 days but fewer than 28 days after the DOV more than 28 days but fewer than 35 days after the DOV



The resulting report includes data for forms that have ALL selected options. If you leave all checkboxes blank, the report will include data for forms with all options.

Sort options

CRF Aging by User

Sort Default selection First level sort: Rights Group

Second level sort: User Name


CRF Aging by User

Sort Default selection Third level sort: Site Mnemonic

Use the sort drop-down boxes to change any of these selections.

Report/Graph page: CRF Aging by User This section describes the CRF Aging by User report/graph page.

Subtotals and totals Subtotals— by User Name and Rights Group Totals—overall form count totals

Column descriptions:

The following table describes the columns on the CRF Aging by User report:

CRF Aging by User Column Description Rights Group Data displayed: String



User Name Data displayed: String







Description: The number of subjects who have enrolled at the site.

How calculated: For each site, a subject is counted if the subject has been enrolled in InForm software. Note that this count includes subjects who have enrolled and have moved on to other states, such as randomized, dropped out, or complete.



CRF Aging by User Column Description Form Counts: Expected











Form Counts: Complete






Form Counts: Incomplete







CRF Aging by User Column Description Form Counts: Not Started







Incomplete (From DOV) Form Counts










CRF Cycle Time Detail by Site

This report shows the measures of data entry performance by showing the number of days, from

date of visit to form started form started to form completed form completed to verified

Note the calculation of visit to form started relies on the use of specified DOV elements in the form design. (See About DOV controls (on page 15) for more information.)

Selection criteria: CRF Cycle Time Detail by Site prompt page Use the CRF Cycle Time Detail by Site prompt page to select criteria and specify sort options for your report.


Selection Criteria

CRF Cycle Time Detail by Site Selection Criteria Selection criteria Action Countries Choose one of these actions:

Select one or more countries from the list to report on specific countries. Click Update after your selection to update the Sites list.



Select one or more sites from the list to report on specific sites

Make no selection to include all listed sites in your report

Visits Choose one of these actions:

Select one or more visits from the list to report on specific visits.

Make no selection to include all visits in your report.

Sort options


Sort Default selection First level sort: Country




Sort Default selection Third level sort: Visit Order


Report/Graph page: CRF Cycle Time Detail by Site This section describes the CRF Cycle Time Detail by Site report/graph page.

Graphs

A combination line/bar graph appears on the first page of the CRF Cycle Time Detail by Site report, plotting the median time from DOV to form complete against expected forms.

Subtotals and totals Subtotals— by Site Totals—overall form count totals

Column descriptions

The following table describes the columns in the CRF Cycle Time Detail by Site report:

CRF Cycle Time Detail by Site Column Description Country Data displayed: String







CRF Cycle Time Detail by Site Column Description Visit Mnemonic Data displayed: String



Form Counts: Expected











Form Counts: Started Data displayed: Numeric




Form Counts: Completed







CRF Cycle Time Detail by Site Column Description DOV to Form Started (Days): Min, Max, Median


Description: The number of days from the recorded date of visit to when forms were started in InForm software. For each visit, this column displays

the minimum number of days from DOV to Form Started the maximum number of days from DOV to Form Started the median for all forms in the visit

How calculated: For each started form, the DOV to Form Started calculation begins on the recorded date of visit for the visit and ends on the day the form's status was set to started. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.

Data Source: Minimum, maximum, and median values derived by InForm Reporting and Analysis and not stored in the Inform Reporting database. Cycle time for each individual form is stored in the reporting database.

DOV to Form Completed (Days): Min, Max, Median


Description: The number of days from the recorded date of visit to when forms were completed in InForm software. For each visit, this column displays

the minimum number of days from DOV to Form Completed the maximum number of days from DOV to Form Completed an median number of days or all forms in the visit

How calculated: For each completed form, the DOV to Form Completed calculation begins on the recorded date of visit for the visit and ends on the last day a form was assigned a status of complete. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.

A form is counted as complete if it is expected and meets the following criteria:




CRF Cycle Time Detail by Site Column Description Form Completed to SV Complete (Days): Min, Max, Median


Description: The number of days from when a form was completed to when it was marked SV complete in InForm software. For each visit, this column displays

the minimum number of days from completed to SV complete status

the maximum number of days from completed to SV complete status

the median for all forms in the visit

How calculated: For each SV Complete form, the Completed to SV complete calculation begins on the first day a forms status is set to completed and ends on the most recent day the forms status was set to SV complete.


Form Completed to Form Locked (Days): Min, Max, Median


Description: The number of days from when a form was completed to when it was locked in InForm software. This report displays the minimum, maximum, and median number of days for forms in each visit. For each visit, this column displays

the minimum number of days from completed to locked status the maximum number of days from completed to locked

status the median for all forms in the visit

How calculated: For each locked form, the Completed to locked calculation begins on the first day a forms status is set to completed and ends on the most recent day the forms status was set to locked.



CRF Cycle Time Detail by User

This report shows the cycle time performance from:

Date of visit to form started Date of visit to form completion Form completion to source verification Form completion to form locked

User reports can return a large amount of data. User reports will be more manageable if you select one rights group, or a set of specific users, such as primary CRAs, for each report.

Selection criteria: CRF Cycle Time Detail by User prompt page Use the CRF Cycle Time Detail by User prompt page to select criteria and specify sort options for your report.


Selection criteria


Selection criteria Action Rights Groups Choose one of these actions::

Select one or more rights groups from the list to report on rights groups. Click Update after your selection to update the Users list

Make no selection to include all rights groups in your report.

Users If you updated the Users list after selecting one or more rights groups, choose one of these actions:

Select one or more users from the list to report on specific users. Click Update after your selection to update the Sites list.

Make no selection to include all listed users in your report






Selection criteria Action Visits Choose one of these actions:



Sort options




Third level sort: Site


Report/Graph page: CRF Cycle Time Detail by User This section describes the CRF Cycle Time Detail by User report report/graph page.

Subtotals and totals Subtotals— by Site, User, and Rights Group Totals—overall form count totals

Column descriptions

The following table describes the columns in the CRF Cycle Time Detail by User report:

CRF Cycle Time Detail by User Column Description Rights Group Data displayed: String




CRF Cycle Time Detail by User Column Description User Name Data displayed: String






Visit Mnemonic Data displayed: String



Form Counts: Expected












CRF Cycle Time Detail by User Column Description Form Counts: Started Data displayed: Numeric




Form Counts: Completed






DOV to Forms Started (Days): Min, Max, and Median


Description: The number of days from the recorded date of visit to when forms were started in InForm software. For each visit, this column displays

the minimum number of days from DOV to Form Started the maximum number of days from DOV to Form Started the median for all forms in the visit

How calculated: For each started form, the DOV to Form Started calculation begins on the recorded date of visit for the visit and ends on the day the form's status was set to started. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.



CRF Cycle Time Detail by User Column Description DOV to Forms Completed (Days): Min, Max, and Median


Description: The number of days from the recorded date of visit to when forms were completed in InForm software. For each visit, this column displays

the minimum number of days from DOV to Form Completed the maximum number of days from DOV to Form Completed an median number of days or all forms in the visit

How calculated: For each completed form, the DOV to Form Completed calculation begins on the recorded date of visit for the visit and ends on the last day a form was assigned a status of complete. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.

A form is counted as complete if it is expected and meets the following criteria:



Forms Completed to Forms SV Completed (Days): Min, Max, and Median


Description: The number of days from when a form was completed to when it was marked SV complete in InForm software. For each visit, this column displays



the median for all forms in the visit

How calculated: For each SV Complete form, the Completed to SV complete calculation begins on the first day a forms status is set to completed and ends on the most recent day the forms status was set to SV complete.



CRF Cycle Time Detail by User Column Description Forms Completed to Forms Locked (Days): Min, Max, and Median


Description: The number of days from when a form was completed to when it was locked in InForm software. This report displays the minimum, maximum, and median number of days for forms in each visit. For each visit, this column displays


status the median for all forms in the visit

How calculated: For each locked form, the Completed to locked calculation begins on the first day a forms status is set to completed and ends on the most recent day the forms status was set to locked.



CRF Site Performance Summary by Site

This report provides a snapshot of how well sites are managing to keep up with entering an completing form data entry activities by listing average time from visit to entry start and complete, combined with aging for incomplete forms.

Selection criteria: CRF Site Performance Summary by Site prompt page Use the CRF Site Performance Summary by SIte prompt page to select criteria and specify sort options for your report.


CRF Site Performance Summary by Site Selection criteria Action Countries Choose one of these actions:






Aging Interval Enter a time duration (in days) to be used as the aging interval. The resulting report uses the aging interval to show how many forms have been incomplete during specific ranges of calendar days after the date of visit.



Sort options

CRF Site Performance Summary by Site






Report/Graph page: CRF Site Performance Summary by Site This section describes the CRF Site Performance Summary by Site report/graph page.

Graphs

Two bar graphs appear on the first page of the CRF Site Performance Summary by Site report. The first plots the median time from DOV to form started and median DOV to form complete times for selected sites. against expected forms. The second plots incomplete form count for selected sites

Subtotals and totals Subtotals— by Country Totals—overall cycle time totals

Drilldown reports

You can click the value in the site mnemonic column to drill down to the Cycle Time Detail by Site report.

Column descriptions

The following table describes the columns in the CRF Site Performance Summary by Site report:

CRF Site Performance Summary by Site Column Description Country Data displayed: String







CRF Site Performance Summary by Site Column Description DOV to Forms Started (Days): Min, Max, Median


Description: The number of days from the recorded date of visit to when forms were started in InForm software. For each site, this column displays

the minimum number of days from DOV to Form Started the maximum number of days from DOV to Form Started the median number of days for all forms in all visits at each

site

How calculated: For each started form, the DOV to Form Started calculation begins on the recorded date of visit for the form and ends on the day the form's status was set to started. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.


DOV to Forms Complete (Days): Min, Max, Median


Description: The number of days from the recorded date of visit to when forms were completed in InForm software. For each site, this column displays

the minimum number of days from DOV to Form Completed the maximum number of days from DOV to Form Completed the median number of days for all forms in all visits at each

site

How calculated: For each completed form, the DOV to Form Completed calculation begins on the recorded date of visit for the form and ends on the last day a form was assigned a status of complete. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.



CRF Site Performance Summary by Site Column Description Forms Completed to Forms SV Complete (Days): Min, Max, Median


Description: The number of days from when a form was completed to when it was marked SV complete in InForm software. For each site, this column displays



the median number of days or all forms in all visits at the site

How calculated: For each SV complete form, the Completed to SV complete calculation begins on the first day a forms status is set to completed and ends on the most recent day the form's status was set to SV complete. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.

Forms Completed to Forms Locked (Days): Min, Max, Median


Description: The number of days from when a form was completed to when it was locked in InForm software. For each site, this column displays


status the median number of days for all forms in all visits at each

site

How calculated: For each locked form, the Completed to locked calculation begins on the first day a forms status is set to completed and ends on the most recent day the forms status was set to locked. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.



CRF Site Performance Summary by Site Column Description Forms Incomplete (Days)










CRF Site Performance Summary by User

This report provides a snapshot of how well sites are managing to keep up with entering and completing form data entry activities by listing average time from visit to data entry start and complete, combine with aging for incomplete forms.

User reports can return a large amount of data. User reports will be more manageable if you select one rights group, or a set of specific users, such as primary CRAs, for each report. See About data in Standard Reports (on page 152) for more information.

Selection criteria: CRF Site Performance Summary by User prompt page Use the CRF Site Performance Summary by User prompt page to select criteria and specify sort options for your report.



Selection criteria Action Rights Groups Select the rights group or groups used for CRAs that are






Aging interval Enter a time duration (in days) to be used as the aging interval. The resulting report uses the aging interval to show how many forms have been incomplete during specific ranges of calendar days after the date of visit.


7 or fewer days after the date of visit more than 7 days but fewer than 14 days after the DOV more than 14 days but fewer than 28 days after the DOV

more than 28 days after the DOV


Sort options




Third level sort: Site Mnemonic


Report/Graph page: CRF Site Performance Summary by User This section describes the CRF Site Performance Summary by User report/graph page.

Subtotals and totals Subtotals— by Site, User, and Rights Group Totals—overall cycle time totals

Drilldown reports

You can click the value in the site mnemonic column to drill down to the CRF Cycle Time Detail by User report.

Column descriptions

The following table describes the columns in the CRF Site Performance Summary by User report:

CRF Site Performance Summary by User Column Description Rights Group Data displayed: String







CRF Site Performance Summary by User Column Description Site Mnemonic Data displayed: String



DOV to Forms Started (Days): Min, Max, Median


Description: The number of days from the recorded date of visit to when forms were started in InForm software. For each site, this column displays

the minimum number of days from DOV to Form Started the maximum number of days from DOV to Form Started the median number of days for all forms in all visits at each

site

How calculated: For each started form, the DOV to Form Started calculation begins on the recorded date of visit for the form and ends on the day the form's status was set to started. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.


DOV to Forms Completed (Days): Min, Max, Median


Description: The number of days from the recorded date of visit to when forms were completed in InForm software. For each site, this column displays

the minimum number of days from DOV to Form Completed the maximum number of days from DOV to Form Completed the median number of days for all forms in all visits at each

site

How calculated: For each completed form, the DOV to Form Completed calculation begins on the recorded date of visit for the form and ends on the last day a form was assigned a status of complete. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.



CRF Site Performance Summary by User Column Description Forms Completed to Forms SV Completed (Days): Min, Max, Median


Description: The number of days from when a form was completed to when it was marked SV complete in InForm software. For each site, this column displays



the median number of days or all forms in all visits at the site

How calculated: For each SV complete form, the Completed to SV complete calculation begins on the first day a forms status is set to completed and ends on the most recent day the form's status was set to SV complete. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.

Forms Completed to Forms Locked (Days): Min, Max, Median


Description: The number of days from when a form was completed to when it was locked in InForm software. For each site, this column displays


status the median number of days for all forms in all visits at each

site

How calculated: For each locked form, the Completed to locked calculation begins on the first day a forms status is set to completed and ends on the most recent day the forms status was set to locked. Note that this report element assumes that your trial has been developed using a specific design for DOV controls. See About DOV controls (on page 15) for more information.



CRF Site Performance Summary by User Column Description Incomplete (from DOV) Form Count (Days)










CRF Status Detail by Site and Subject

This report shows the number of forms in each possible status:

Selection criteria: CRF Status Detail by Site and Subject prompt page Use the CRF Status Detail by Site and Subject prompt page to select criteria and specify sort options for your report.


CRF Status Detail by Site and Subject Selection criteria Action Countries Choose one of these actions:






Subjects If you updated the Subjects list after selecting one or more sites, choose one of these actions:

Select one or more subjects from the list to report on specific subjects.

Make no selection to include all listed subjects in your report.





CRF Status Detail by Site and Subject Selection criteria Action Expected forms for Filter the report by expected forms. Choose one of these










If you leave all checkboxes blank, the report will include all of these options.

Sort options

CRF Status Detail by Site and Subject



Third level sort: Subject Number



Report/Graph page: CRF Status Detail by Site and Subject This section describes the CRF Status Detail by Site and Subject report/graph page.

Subtotals and totals Subtotals— by Subject, Site, and Country Totals—overall form count totals

Column descriptions

The following table describes the columns in the CRF Status Detail by Site and Subject report.

CRF Status Detail by Site and Subject Column Description Country Data displayed: String






Subject Number Data displayed: String

Description: The Subject Number, followed by Subject Initials, for the subject.

Data Source: Replicated from the InForm Transactional database to the Reporting database. Derived for display.




DOV Data displayed: Date/Time




CRF Status Detail by Site and Subject Column Description Form Count (% of Expected): Expected











Form Count ( % of Expected): Not Started








CRF Status Detail by Site and Subject Column Description Form Count (% of Expected): Incomplete


Description: The number of expected forms that are started but incomplete, and the percentage of expected forms that are incomplete.

How calculated: A form is counted as incomplete if either of the following is true:

the form contains at least one required item that has no data the form contains at least one item with one open query

This value is displays as a whole number, followed by a percentage expected forms that are incomplete. The percentage is calculated as follows:

<% incomplete> = <incomplete forms> * 100 / <expected form count>


Form Count (% of Expected): Completed


Description: The number of forms that have been completed, and the percentage of expected forms that are complete in InForm software.

How calculated: A form is counted as complete if it meets both of the following criteria:

All required items contain data No open queries are associated with any items on the form

This value displays as a whole number and as a percentage of expected forms that are complete:

<% complete> = <complete forms> * 100 / <expected forms>

Data Source: Replicated from the InForm Transactional database to the Reporting database. Percentage derived for display.

Form Count (% of Expected): Frozen


Description: The number of expected forms that are frozen. This value displays as a whole number and as a percentage of the total number of expected forms that are frozen.





CRF Status Detail by Site and Subject Column Description Form Count (% of Expected): SV Partial


Description: The number of SV Partial forms, and the percentage of expected forms where source verification is not complete.

How calculated: A form is counted as SV partial if it is expected and if only some of the SV-required items on the form have been source verified, and others have not. InForm software automatically assigns a status of SV partial to any form for which some, but not all, SV-required items have been marked SV complete.

This value is displayed as a whole number and as a percentage of the total number of expected forms that are marked SV partial:

<% SV partial> = <SV partial form count> * 100 / <expected forms>


Form Count (% of Expected) SV Completed

Data displayed: Percentage

Description: The number of SV complete forms, and the percentage of expected forms where source verification is complete.


This value displays as a whole number and as a percentage of the total number of expected forms that are marked SV complete:

<% SV complete> = <SV complete form count> * 100 / < expected form count>


Form Count (% of Expected): Signed


Description: The number of expected forms that have been signed in InForm software.


it has been signed in InForm software it is contained within a casebook that has been signed in

InForm software

This value displays as a whole number and as a percentage of the total number of expected forms that are signed.

<% signed> = <signed form count> * 100 / <expected form count>



CRF Status Detail by Site and Subject Column Description Form Count (% of Expected): Locked


Description: The number of expected forms that are locked, and the percentage of expected forms that are locked.

How calculated: A form is counted if any of the following conditions is true:

it has been locked in InForm software it is contained within a casebook that has been locked in

InForm software it is contained within a visit that has been locked in InForm

software

This value displays as a whole number and as a percentage of the total number of expected forms that are locked:

<% locked> = < locked form count> * 100 / <expected form count>


Form Counts (% of Expected): Forms with Comments


Description: The number of expected forms with form-level comments, and the percentage of expected forms that have form-level comments.

How calculated: A form is included if it contains either a form-level comment. Forms with item-level comments only are not counted. This value displays as a whole number and a percentage of the total number of expected forms that have comments:

<% forms with comments> = <forms with comments> * 100 / <expected form count>


Form Counts (% of Expected): Forms with Queries


Description: The number of forms with open queries, and the percentage of expected forms that contain open queries.

How calculated: A form is counted if it contains an item with an open query. This value displays as a whole number and a percentage of the total number of expected forms that have open queries:

<% forms with open queries> = <forms with open queries> * 100 / <expected form count>



CRF Status Detail by Visit and Site

This report shows the number of forms in each possible status, organized by visit across sites.

Selection criteria: CRF Status Detail by Visit and Site report prompt page Use the CRF Status Detail by Visit and Site prompt page to select criteria and specify sort options for your report.


Selection criteria

CRF Status Detail by Visit and Site Selection criteria Action Countries Choose one of these actions::

Select one or more countries from the list to report on specific countries. Click Update after your selection to update the Sites list.



Select one or more sites from the list to report on specific sites. Click Update after your selection to update the Subjects list.

Make no selection to include all listed sites in your report

Subjects If you updated the Subjects list after selecting one or more sites,a list of Subject Numbers appears. Choose one of these actions:

Select one or more of the subject numbers to report on specific subjects.






CRF Status Detail by Visit and Site Selection criteria Action Expected forms for Filter the report by expected forms. Choose one of these











Sort options

CRF Status Detail by Visit and Site


Second level sort: Visit Order




Report/Graph page: CRF Status Detail by Visit and Site This section describes the CRF Status Detail by Visit and Site report/graph page.

Subtotals and totals Subtotals— by Site, Visit, and Country Totals—overall form count totals

Column descriptions

The following table describes the columns on the CRF Status Detail by Visit and Site report:

CRF Status Detail by Visit and Site Column Description Country Data displayed: String










CRF Status Detail by Visit and Site Column Description Subject Number Data displayed: String



Note that:








Form Count (% of Expected) :Expected












CRF Status Detail by Visit and Site Column Description Form Count (% of Expected): Incomplete



How calculated: A form is counted as incomplete if it is started, but is not complete. This value displays as a whole number and as a percentage of the total number of expected forms that are incomplete:

<% incomplete> = <incomplete forms> * 100 / <expected forms>



How calculated: A form is counted as complete if it is expected and meets both of the following criteria:


Form Count (% of Expected): Frozen


Description: The number of frozen forms, and the percentage of expected forms that are currently marked frozen in InForm software.



This value displays as a whole number (number of frozen forms), followed by the percentage of expected forms that are currently marked frozen:

<% frozen> = < frozen forms> * 100 / <expected forms>



CRF Status Detail by Visit and Site Column Description Form Count (% of Expected): SV Partial


Description: The number of SV Partial forms, and the percentage of expected forms where source verification is not complete.

How calculated: A form is counted as SV partial if it is expected and if only some of the SV-required items on the form have been source verified, and others have not. InForm software automatically assigns a status of SV partial to any form for which some, but not all, SV-required items have been marked SV complete.

This value is displayed as a whole number and as a percentage of the total number of expected forms that are marked SV partial:

<% SV partial> = <SV partial form count> * 100 / <expected forms>


Form Count (% of Expected) SV Completed

Data displayed: Percentage

Description: The number of SV complete forms, and the percentage of expected forms where source verification is complete.


This value displays as a whole number and as a percentage of the total number of expected forms that are marked SV complete:

<% SV complete> = <SV complete form count> * 100 / < expected form count>




Description: The number of expected forms that have been signed in InForm software.



InForm software

This value displays as a whole number and as a percentage of the total number of expected forms that are signed.

<% signed> = <signed form count> * 100 / <expected form count>



CRF Status Detail by Visit and Site Column Description Form Count (% of Expected): Locked


Description: The number of expected forms that are locked, and the percentage of expected forms that are locked.

How calculated: A form is counted if any of the following conditions is true:



software

This value displays as a whole number and as a percentage of the total number of expected forms that are locked:

<% locked> = < locked form count> * 100 / <expected form count>


How calculated: A form is counted as locked if it has been locked with the lock feature of InForm software.

Form Counts (% of Expected): Forms with Comments


Description: The number of expected forms with form-level comments, and the percentage of expected forms that have form-level comments.

How calculated: A form is included if it contains a form-level comment. Forms with item-level comments only are not counted. This value displays as a whole number and a percentage of the total number of expected forms that have comments:

<% forms with comments> = <forms with comments> * 100 / <expected form count>

Form Counts (% of Expected): Forms with Queries


Description: The number of forms with open queries, and the percentage of expected forms that contain open queries.

How calculated: A form is counted if it contains an item with an open query. This value displays as a whole number and a percentage of the total number of expected forms that have open queries:

<% forms with open queries> = <forms with open queries> * 100 / <expected form count>



CRF Status Summary by Site

This report shows the total number and percentage of expected forms that are incomplete, complete, frozen, and locked. This report is grouped by site.

Selection criteria: CRF Status Summary by Site prompt page Use the CRF Status Summary by Site prompt page to select criteria and specify sort options for your report.


Selection criteria


Selection criteria Action Countries Choose one of these actions:















Selection criteria Action Limit to forms with Select one or more options to filter the report to include only

forms with:



Sort options







Report/Graph page: CRF Status Summary by Site This section describes the CRF Status Summary by Site report/graph page.

Graphs

A bar graph appears on the first page of the CRF Status Summary by Site report, plotting a summary of form completion status across all sites.

Subtotals and totals Subtotals— by Country Totals—overall form count totals

Drilldown reports

Click the value in the Site Mnemonic column to drill down to the CRF Status Detail by Visit and Site report for the selected site.

Click the value in the Subject Count column to drill down to the CRF Status Detail by Visit and Site report for the subjects included in the subject count.

Column descriptions

The following table describes the columns in the CRF Status Summary by Site report:

CRF Status Summary by Site Column Description Country Data displayed: String







CRF Status Summary by Site Column Description Subject Count Data displayed: Numeric

Description: For each site, the number of subjects who have ever been enrolled in the study through InForm software.

How calculated: A subject is counted if an Enrollment form was completed and successfully submitted for the subject. Note that this count includes subjects whose states have changed from enrolled to a new state; the count includes all subjects who have ever been in the enrolled state.


Form Count (% of Expected: Expected)












CRF Status Summary by Site Column Description Form Count ( % of Expected: Not Started)







Form Count (% of Expected) Incomplete



How calculated: A form is counted as incomplete if either of the following is true:

the form contains at least one required item that has no data the form contains at least one item with one open query

This value is displays as a whole number, followed by a percentage expected forms that are incomplete. The percentage is calculated as follows:

<% incomplete> = <incomplete forms> * 100 / <expected form count>











CRF Status Summary by Site Column Description Form Count (% of Expected) Frozen








Form Count (% of Expected) SV Complete


Description: The number of SV complete forms, and the percentage of expected forms that are currently SV complete in InForm software.


This value displays as a whole number and as a percentage of expected forms that are marked SV complete:

<% SV complete> = <SV complete form count> * 100 / <expected form count>


Form Count (% of Expected) Signed


Description: The number of signed forms.

How calculated: A form is counted if it has been signed in InForm software



CRF Status Summary by Site Column Description Form Count (% of Expected) Locked


Description: The number of locked forms and the percentage of expected forms that are locked in InForm software.




software

This value displays as a whole number and as a percentage:

<% locked> = <locked forms> * 100 / <expected form count>



CRF Status Summary by User

This report shows the total number and percentage of expected forms that are incomplete, complete, frozen, locked, SV complete, and signed. This report is grouped by visits.

Selection criteria: CRF Status Summary by User prompt page Use the CRF Status Summary by User prompt page to select criteria and specify sort options for your report.


Selection criteria

CRF Status Summary by User Selection criteria Action Rights Groups Select the rights group or groups used for CRAs that are














CRF Status Summary by User Selection criteria Action Limit to forms with Select one or more options to filter the report to include only

forms with:



Sort options for the CRF Status Summary by User report

CRF Status Summary by User report






Report/Graph page: CRF Status Summary by User This section describes the CRF Status Summary by User report/graph page.

Subtotals and totals Subtotals— none Totals—overall form count totals

Drill down reports

Click the value in the Site Mnemonic column to drill down to the CRF Status Detail by Visit and Site report for the selected site.

Click the value in the Enrolled to drill down to the CRF Status Detail by Site and Subject report for the selected user.

Column descriptions

The following table describes the columns on the CRF Status Summary by User report.

CRF Status Summary by User Column Description Rights Group Data displayed: String










CRF Status Summary by User Column Description Subject Count Data displayed: Numeric




Form Count (% of Expected): Expected












CRF Status Summary by User Column Description Form Count (% of Expected): Not Started







Form Count (% of Expected): Incomplete















CRF Status Summary by User Column Description Form Count (% of Expected) Frozen


Description: The number of frozen forms, and the percentage of expected forms that are currently marked frozen in InForm software.



This value displays as a whole number and as a percentage of expected forms that are frozen:

<% frozen> = <frozen forms> * 100 / <expected forms>


Form Count (% of Expected): SV Completed


Description: The number of SV complete forms, and the percentage of expected forms that are currently SV complete in InForm software.


This value displays as a whole number and as a percentage of expected forms that are marked SV complete:

<% SV complete> = <SV complete form count> * 100 / <expected form count>




Description: The number of signed forms and the percentage of expected forms that are signed in InForm software.



InForm software

This value displays as a whole number and as a percentage of expected forms that are signed:

<% signed> = <signed forms> * 100 / <expected form count>



CRF Status Summary by User Column Description Form Count (% of Expected): Locked


Description: The number of locked forms and the percentage of expected forms that are locked in InForm software.




software

This value displays as a whole number and as a percentage:

<% locked> = <locked forms> * 100 / <expected form count>


217

Item reports provide information about the progress of item source verification, as well as listings of items on forms.

In This Chapter CRF Item Listing...........................................................218 Source Verification Listing............................................224

C H A P T E R 8

Item reports


CRF Item Listing

This report shows a list of form items that are in a given state or entered a given state as of a point in time. The report is broken out by site, subject, visit, form, and item.

Note that this report displays only those items that meet any of the following criteria:

data has been entered into the item queries have been issued against the item

Selection criteria: CRF Item Listing Use the CRF Item Listing prompt page to select criteria and specify sort options for your report.


Note that you must make a selection from the Visits drop-down list before you can access the More Options page, or run the report.

CRF Item Listing Selection criteria Action Countries Choose one of these actions:









Chapter 8 Item reports 219

CRF Item Listing Selection criteria Action Limit to forms that are Select one or more options to filter the report to include only

items in forms that are:

SV Ready Not SV Complete Partially SV Complete SV Complete Frozen Signed Locked

The resulting report includes items in all form states you select. If you leave all checkboxes blank, the report includes all applicable forms

Limit to items that are Select one or more options to filter the report to include only items that are:

Required SV Required With Queries With Comments Unverified (no longer verified) Verified No Longer Verified

The resulting report includes data for only the types of items you select. If you leave all checkboxes blank, the report will include all applicable items.

Date last modified date range

Specify a From and To date by entering dates, or using the calendar icons to select the date range to include in your report. .

The resulting report includes data for items that were last modified within the date range specified.

Sort options for the CRF Item Listing report

CRF Item Listing

Sort Default selection First level sort: Site

Second level sort: Subject Number

Third level sort: Visit

Fourth level sort Form



Report/Graph page: CRF Item Listing This section describes the CRF Item Listing report/graph page.

Link to form items

Click the value in the Form column to link directly to the item question on the InForm form.

Column descriptions

The following table describes the columns in the CRF Item Listing report.

CRF Item Listing Column Description Site Data displayed: String



Subject Number/Initials Data displayed: String

Description: The subject number, followed by the subject initials.

The subject number automatically assigned to the subject when the subject's screening form is completed and submitted. This number, and the subject initials, can also be changed post enrollment, if configured in the trial.

Note that:




Visit Data displayed: String







CRF Item Listing Column Description Form Data displayed: String



Form index Data displayed: Numeric

Description: A numeric ordinal value that indicates each iteration of a repeating form.


Item Question Data displayed: String

Description: Text of the question or prompt that instructs the user to enter specific clinical data.


Form State Dates: SV Ready


Description: The most recent date on which the form's status was set to SV ready in InForm software. Note that a value displays here only if the form has a current status of SV ready.


Form State Dates: Frozen


Description: The most recent date on which the form's status was set to frozen in InForm software. Note that a value displays here only if the form has a current status of frozen.


Form State Dates: SV Complete


Description: The most recent date on which the form's status was set to SV complete in InForm software. Note that a value displays here only if the form has a current status of SV complete.


Form State Dates: Signed


Description: The most recent date on which the form's status was set to signed in InForm software. Note that a value displays here only if the form has a current status of signed.



CRF Item Listing Column Description Form State Dates: Locked


Description: The most recent date on which the form's status was set to locked in InForm software. Note that a value displays here only if the form has a current status of locked.

A form is counted if either of the following conditions is true:



software


Item Properties: Required


Description: The total number of required items that have ever contained data.


the item is required the item contains (or has ever contained) clinical data


Item Properties: SV Required

Data displayed: Y/N

Description: Indicates whether the item requires source verification in InForm software

Y: The item requires InForm source verification N: The item does not require source verification


Item Properties: Verified

Data displayed: Y/N

Description: Indicates whether the item has been source verified:

Y: The item is verified N: The item is not verified

This field is not supported in Add Entry items.



CRF Item Listing Column Description Item Properties: Has Query

Data displayed: Y/N

Description: Indicates whether the item has an open query associated with it.

Y: The item has a query N: The item does not have a query



Item Properties: Has Comment

Data displayed: Y/N

Description: Indicates whether the item has a comment associated with it.

Y: The item has a comment N: The item does not have a comment



Item Properties: Data Modified




Item Properties: Original Value Date


Description: The date on which data was originally entered into the item.


Item Properties: Data Change User





Source Verification Listing

This report shows form items based on date range and SV status. This report shows only SV required items.

Selection criteria: Source Verification Listing Use the Source Verification Listing prompt page to select criteria and specify sort options for your report.


Source Verification Listing Selection criteria Action Countries Choose one of these actions:












Forms Choose one of these actions:

Select one or more forms from the list of form mnemonics to report on specific forms.

Make no selection to include all forms in your report.


Source Verification Listing Selection criteria Action Form completion status

Filter the report by data entry form completion. Select one of these options from the drop-down list:

Any Forms—includes all data entry incomplete and data entry complete expected forms.

Only Incomplete Forms—includes only expected forms that have been started by are not yet data entry complete

Only Complete Forms—Includes only expected forms that are data entry complete.

Visit start date range: Select a date range for the visit start date. Use the calendar icons to select the date range to include in your report. The resulting report will include data for all visits that were started within the range you select.

Limit to: Select one or more options to filter the report to include only these items:

Items with Queries Items with Comments Unverified Items Verified Items No Longer Verified Items

The resulting report displays data items that have all of the selected criteria. If you leave all checkboxes blank, the report will include all of applicable forms.

Sort options for the Source Verification Listing report

Source Verification Listing

Sort Default selection First level sort: Site

Second level sort: Subject Number

Third level sort: Visit

Fourth level sort: Form



Report/Graph page: Source Verification Listing This section describes the Source Verification Listing report/graph page.

Link to form items

Click the value in the Form column to link directly to the item question on the InForm form. From here, you can see the data entered for the item.

Column descriptions

The following table describes the columns in the Source Verification Listing report:

Source Verification Listing Column Description Site Data displayed: String






Note that:





Visit Data displayed: String




Source Verification Listing Column Description DOV Data displayed: Date

Description: The date recorded in a standard Date of Visit t control in InForm software. Note that this report element retrieves a date stored when your DOV controls are designed in a specific way. See About DOV controls (on page 15) for more information.


Form Data displayed: String



Form Index Data displayed: Numeric

Description: A numeric ordinal value that indicates each iteration of a repeating form.


Item Question Data displayed: String

Description: Text of the question or prompt that instructs the user to enter specific clinical data. Note that access to this data can be restricted in InForm software. When users who have no access to this data run a report with this report element, the resulting report displays a series of asterisks ******** rather than the actual item question.

Note that InForm items that have never contained data will not appear on reports that pair Item Question with Form Name or Form Mnemonic.


Status Change User Data displayed: String

Description: The username of the InForm user who made the most recent status change to the item in InForm software.


Verified Data displayed: Y/N

Description: Indicates whether the item has been source verified:

Y: The item is verified N: The item is not verified




Source Verification Listing Column Description Last Verified Data displayed: Date

Description: The most recent date on which the item was source verified.


Data Change User Data displayed: String



Data Last Modified Data displayed: Date



229

The Query reports provide information about the volume of query activity and the progress from query opening to resolution.

In This Chapter Outstanding Queries by Site and Visit .........................230 Query Aging by Site .....................................................233 Query Cycle Times by Site...........................................236 Query Cycle Times by User .........................................240 Query Performance Summary by Site .........................244 Query Performance Summary by User ........................248 Query Status by Site ....................................................252 Query Status by Site and Subject ................................256 Query Status by Site and Visit .....................................260 Query Status by User ...................................................264 Query Volume by Month by Site ..................................268 Query Volume by Month by User .................................272 Query Volume by Rule .................................................276 Subject Counts with Outstanding Queries ...................278

C H A P T E R 9

Query reports


Outstanding Queries by Site and Visit

This cross-tab report shows the number of open or answered queries for each visit and site.

Selection criteria: Outstanding Queries by Site and Visit Use the Outstanding Queries by Site and Visit prompt page to select criteria and specify sort options for your report.


Outstanding Queries by Site and Visit Selection criteria Action Countries Choose one of these actions:









Query Type Select one of the options below to specify whether you want the report to include either:

Auto Manual

If you leave all checkboxes blank, the report will include both of these options.

Sort options for the Outstanding Queries by Site and Visit report

Outstanding Queries by Site and Visit




Chapter 9 Query reports 231


Report/Graph page: Outstanding Queries by Site and Visit This section describes the Outstanding Queries by Site and Visit report/graph page.

Subtotals and totals Subtotals— by Country Totals—overall query count totals

Column descriptions

The following table describes the columns in the Outstanding Queries by Site and Visit report:

Outstanding Queries by Site and Visit Report element Description Countries Data displayed: String



Site Data displayed: String



Open query counts by visit


Description: For each visit, the number of queries with a current status of open.

How calculated: For each site and visit, all open queries associated with items on any form in the visit are counted. This calculation counts open queries of type manual, automatic, or both, based on the Query Type filter specified on the report prompt page. Note that this total includes queries that were opened, answered, and then reissued.



Outstanding Queries by Site and Visit Report element Description Answered query counts by visit


Description: For each site, the number of queries there were answered for each visit.

How calculated: For each site and visit, all answered queries associated with items on any form in the visit are counted. This calculation counts manual, automatic, or both types of answered queries, based on the Query Type filter specified on the report prompt page.


Total query counts by visit


Description: For each site, the total number of open and answered queries in a given month.

How calculated: The value displayed in this column is the sum of the values in the Open and Ans'd columns.



Query Aging by Site

Selection criteria: Query Aging by Site Use the Query Aging by Site prompt page to select criteria and specify sort options for your report.


Query Aging by Site Selection criteria Action Country Choose one of these actions:






Aging Interval Enter a time duration (in days) to be used as the aging interval. The resulting report uses the aging interval to show how many open queries have been open for specific numbers of days.

For instance, if you specify 7 here, the resulting report shows the number of open queries that have been open for:

7 or fewer days more than 7 days more than 14 days more than 28 days

Sort options for the Query Aging by Site report

Query Aging by Site






Report/Graph page: Query Aging by Site This section describes the Query Aging by Site report/graph page.

Subtotals and totals Subtotals—by Country Totals—overall query aging totals

Column descriptions

The following table describes the columns in the Query Aging by Site report:

Query Aging by Site Column Description Country Data displayed: String







Description: The number of subjects associated with each site.



Total Open Data displayed: Numeric

Description: For each site, the number of queries with a current state of open.

How calculated: For each site, all queries with a current status of open are counted, regardless of query type. Note that this total includes queries that were opened, answered, and then reissued.



Query Aging by Site Column Description Average Age of Open Data displayed: Numeric

Description: For each site, the average number of days open queries have been in the open state.

How calculated: This calculation applies only to queries with a current status of open. The calculation begins on the date the query was opened and ends on the last date a query had a status of open.

InForm adds the total number of days for each open query at the site, and divides by the number of open queries at the site.


Queries Open (% of Total Open for Country)


Description: The number of open queries that have been open for specific intervals of time. You specify the aging interval (in days) on the report prompt page. For instance, if you specify 7 on the report filter page, the resulting report shows the number of queries that have been open for:

7 or fewer days more than 7 days but fewer than 14 days more than 14 days but fewer than 28 days more than 28 days

How calculated: This value is displays as a whole number, followed by a percentage of the total open query count per country. For each country the percentage is calculated as follows:

<open queries within aging interval> * 100 / <total number of open queries >

Data source: Derived and stored in the InForm Reporting Database. Percentage derived for display.


Query Cycle Times by Site

This report shows the minimum, maximum, and median number of days for queries to move from open to answered to closed. This report is grouped by site or sponsor.

Selection criteria: Query Cycle Times by Site Use the Query Cycle Times by Site prompt page to select criteria and specify sort options for your report.


Query Cycle Times by Site Selection criteria Action Countries Choose one of these actions::






Query Types Select one of the options below to specify whether you want the report to include either:

Auto Manual


Date Range: Specify a From and To date by entering dates, or using the calendar icons to select the date range to include in your report.

The resulting report will include data for all queries opened within the range you select.

Sort options for the Query Cycle Times by Site report

Query Cycle Times by Site






Report/Graph page: Query Cycle Times by Site

This section describes the Query Cycle Times by Site report/graph page.

Graphs A combination line/bar graph appears on the first page of the Query Cycle Times by Site report, plotting the median time from query open-to-answered and answered-to-closed cycle times for selected countries and sites.

Subtotals and totals Subtotals—by Country Totals—overall query cycle time totals

Column descriptions

The following table describes the columns in the Query Cycle Times by Site report:

Query Cycle Times by Site Column Description Country Data displayed: String











Query Cycle Times by Site Column Description Query Count Data displayed: Numeric

Description: The total number of number of open, answered, and closed queries.

How calculated: This calculation counts all open, closed, and answered queries based on the Query Type filter specified on the report prompt page. This count does not include queries that have never been opened (candidate queries or deleted candidate queries.)


Open to Answered (Days): Min, Max, Median


Description: Data on the number of days from when queries are opened to when they are answered. For each site, the column displays:

Minimum—the fewest number of days for an opened query to be answered at the site.

Maximum—the greatest number of days for an opened query to be answered at the site.

Median —the median of the opened-to-answered range for all answered queries at the sites.

How calculated: The open-to-answered calculation begins on the first day a query's status is set to opened and ends on the most recent day the query's status was set to answered.


Answered to Closed (Days): Min, Max, Median


Description: Data on the number of days from when queries are answered to when they are closed. For each site, the column displays:

Minimum—the fewest number of days for an answered query to be closed at the site.

Maximum—the greatest number of days for an answered query to be closed at the site.

Median—the median of the answered-to-closed range for all closed queries at the site.

How calculated: The answered-to-closed calculation begins on the first day a query's status is set to answered and ends on the most recent day the query's status was set to closed.



Query Cycle Times by Site Column Description Open to Closed (Days): Min, Max, Median


Description: Data on the number of days from when queries are opened to when they are closed. For each site, the column displays:

Minimum—the fewest number of days for an opened query to be closed at the site.

Maximum—the greatest number of days for an opened query to be closed at the site.

Median—the median of the opened-to-closed range for all closed queries at the site.

How calculated: The opened-to-closed calculation begins on the first day a query's status is set to answered and ends on the most recent day the query's status was set to closed.



Query Cycle Times by User

This report shows the minimum, maximum, and median number of days for queries to move from open to answered to closed. This report is grouped by site or sponsor.

Selection criteria: Query Cycle Times by User Use the Query Cycle Times by User prompt page to select criteria and specify sort options for your report.


Query Cycle Times by User Selection criteria Action Rights groups Select the rights group or groups used for CRAs that are






Date Range Specify a From and To date by entering dates or by using the calendar icons to select the date range to include in your report.

Use the calendar icons to select the date range to include in your report. The resulting report will include data for all queries opened within the range you select.

Query Types Select one or more options to filter the report to include only these queries:

Auto Manual

If you leave all checkboxes blank, the report will include all of these options

Sort options


Sort Default selection

First level sort: Group Name



Sort Default selection




Report/Graph page: Query Cycle Times by User This section describes the Query Cycle Times by User report/graph page.

Subtotals and totals Subtotals— by User Name and Rights Group Totals—overall query cycle time totals

Column descriptions

The following table describes the columns in the Query Cycle Times by User report:

Query Cycle Times by User Column Description Rights Group Data displayed: String










Query Cycle Times by User Column Description Subject Count Data displayed: Numeric




Query Count Data displayed: Numeric

Description: The total number of number of open, answered, and closed queries.

How calculated: This calculation counts all open, closed, and answered queries based on the Query Type filter specified on the report prompt page. This count does not include queries that have never been opened (candidate queries or deleted candidate queries.)


Open to Answered (Days): Min, Max, Median


Description: Data on the number of days from when queries are opened to when they are answered. For each user, the column displays:

Minimum—the fewest number of days for an opened query to be answered for this user.

Maximum—the greatest number of days for an opened query to be answered for this user.

Median —the median of the opened-to-answered range for all answered queries for this user.

How calculated: The open-to-answered calculation begins on the first day a query's status is set to opened and ends on the most recent day the query's status was set to answered.



Query Cycle Times by User Column Description Answered to Closed (Days): Min, Max, Median


Description: Data on the number of days from when queries are answered to when they are closed. For each user, the column displays:

Minimum—the fewest number of days for an answered query to be closed for this user.

Maximum—the greatest number of days for an answered query to be closed for this user.

Median—the median of the answered-to-closed range for all closed queries for this user.

How calculated: The answered-to-closed calculation begins on the first day a query's status is set to answered and ends on the most recent day the query's status was set to closed.


Open to Closed (Days): Min, Max, Median


Description: Data on the number of days from when queries are opened to when they are closed. For each user, the column displays:

Minimum—the fewest number of days for an opened query to be closed for this user.

Maximum—the greatest umber of days for an opened query to be closed for this user.

Median —the median of the opened- to-closed range for all closed queries for this user.

How calculated: The opened-to-closed calculation begins on the first day a query's status is set to answered and ends on the most recent day the query's status was set to closed.



Query Performance Summary by Site

Selection criteria: Query Performance Summary by Site Use the Query Performance Summary by Site prompt page to select criteria and specify sort options for your report.


Query Performance Summary by Site Selection criteria Action Countries Choose one of these actions:






Query Types Select one of the options below to specify whether you want the report to include either:

Auto Manual


Aging interval Enter a time duration (in days) to be used as the aging interval. The resulting report uses the aging interval to show how many open queries have been open for specific numbers of days.



Sort options






Sort Default selection Third level sort: None


Report/Graph page: Query Performance Summary by Site This section describes the Query Performance Summary by Site report/graph page.

Graphs A bar graph appears on the first page of the Query Performance Summary by Site report, plotting the median query count for casebooks and forms by site and by country.

Subtotals and totals Subtotals—by Country Totals—overall query count totals

Column descriptions

The following table describes the columns on the Query Performance Summary by User report.

Query Performance Summary by Site Column Description Country Data displayed: String







Query Performance Summary by Site Column Description Enrolled Data displayed: Numeric




Queries per CRB Data displayed: Numeric

Description: The maximum and median number of all queries per casebook for all enrolled subjects within each site.

How calculated: For each site, this calculation counts manual, automatic, or both types of queries based on the Query Type filter specified on the report prompt page. This count includes all queries, regardless of status. This calculation includes all subjects who were ever enrolled, regardless of current status.

For each site, the column displays:

Maximum— the maximum number of all queries per case book for all enrolled subjects at the site.

Median—the median number of all queries per case book for all enrolled subjects at the site. Data Source: Derived by InForm Reporting and Analysis (not stored in the Inform Reporting database).

Queries per CRF Data displayed: Numeric

Description: The maximum and median number of open queries per form within each site.

How calculated: For each site, this calculation counts manual, automatic, or both types of open queries based on the Query Type filter specified on the report prompt page. Note that this total includes queries that were opened, answered, and then reissued. For each site, the report displays:

Maximum— the maximum number of open queries associated with a form at the site.

Median—the median number of open queries for all forms at the site.



Query Performance Summary by Site Column Description Days to Resolve (Open to Close)


Description: The minimum, maximum, and median number of days for queries to be opened and closed.

How calculated: For each query, the open-to-closed calculation starts on the first day a query's status was set to open and ends on the most recent date the query's status was set to closed. The value returned is either an exact count or an average, depending on other elements in your report. For each site, the report displays:

Minimum—the fewest number of days taken for a query to be opened and closed at the site.

Maximum—the maximum number of days taken for a query to be opened and closed at the site.

Median— the median number of days for all queries at the site.


Days Open Data displayed: Numeric/Percentage


7 or fewer days more than 7 but fewer than 14 days more than 14 but fewer than 28 days more than 28 days

How calculated: This value is displays as a whole number, followed by a percentage of the total open query count per visit. For each visit, the percentage is calculated as follows:

<open query count within aging interval> * 100 / <open query count>



Query Performance Summary by User

Selection criteria: Query Performance Summary by User Use the Query Performance Summary by User prompt page to select criteria and specify sort options for your report.


Query Performance Summary by User Selection criteria Action Rights groups Select the rights group or groups used for CRAs that are







Auto Manual


Aging Interval Enter a time duration (in days) to be used as the aging interval. The resulting report uses the aging interval to show how many open queries have been open for specific numbers of days.



Sort options


Sort Default selection First level sort: Group Name




Sort Default selection Third level sort: Site Mnemonic


Report/Graph page: Query Performance Summary by User This section describes the Query Performance Summary by User report/graph page.

Subtotals and totals Subtotals— by User Name and Rights Group Totals—overall query count totals

Column descriptions

The following table describes the columns on the Query Performance Summary by User report.

Query Performance Summary by User Column Description Rights Group Data displayed: String










Query Performance Summary by User Column Description Enrolled Data displayed: Numeric




Queries per CRB Data displayed: Numeric

Description: The maximum and median number of all queries per casebook for all enrolled subjects within each site.

How calculated: For each site, this calculation counts manual, automatic, or both types of queries based on the Query Type filter specified on the report prompt page. This count includes all queries, regardless of status. This calculation includes all subjects who were ever enrolled, regardless of current status.

For each site, the column displays:

Maximum— the maximum number of all queries per case book for all enrolled subjects at the site.

Median—the median number of all queries per case book for all enrolled subjects at the site. Data Source: Derived by InForm Reporting and Analysis (not stored in the Inform Reporting database).

Queries per CRF Data displayed: Numeric

Description: The maximum and median number of open queries per form within each site.

How calculated: For each site, this calculation counts manual, automatic, or both types of open queries based on the Query Type filter specified on the report prompt page. Note that this total includes queries that were opened, answered, and then reissued. For each site, the report displays:

Maximum— the maximum number of open queries associated with a form at the site.

Median—the median number of open queries for all forms at the site.



Query Performance Summary by User Column Description Days to Resolve (Open to Close)


Description: The minimum, maximum, and median number of days for queries to be opened and closed.

How calculated: For each query, the open-to-closed calculation starts on the first day a query's status was set to open and ends on the most recent date the query's status was set to closed. The value returned is either an exact count or an average, depending on other elements in your report. For each site, the report displays:

Minimum—the fewest number of days taken for a query to be opened and closed at the site.

Maximum—the maximum number of days taken for a query to be opened and closed at the site.

Median— the median number of days for all queries at the site.


Days Open Data displayed: Numeric/Percentage


7 or fewer days more than 7 but fewer than 14 days more than 14 but fewer than 28 days more than 28 days

How calculated: This value is displays as a whole number, followed by a percentage of the total open query count per visit. For each visit, the percentage is calculated as follows:

<open query count within aging interval> * 100 / <open query count>



Query Status by Site

This report shows the current total queries in each state by site, subject, and visit. This report can also show the number of queries that entered a given state within a specified time period.

Selection criteria: Query Status by Site report Use the Query Status by Site prompt page to select criteria and specify sort options for your report.


Query Status by Site Selection criteria Action Countries Choose one of these actions:






Query type Select one of the options below to specify whether you want the report to include either:

Auto Manual


Sort options

Query Status by Site






Report/Graph page: Query Status by Site This section describes the Query Status by Site report/graph page.


Drill down reports

This report contains links to two drill down reports:

Click the value in the Site Mnemonic column to drill down to Query Status by Site and Visit report for the site.

Click the value in the Subject Count column to drill down to the Query Status by Site and Subject report for the subject.

Column descriptions

The following table describes the columns in the Query Status by Site report:

Query Status by Site Column Description Country Data displayed: String











Query Status by Site Column Description Avg Queries per Patient


Description: The average number of queries associated with each subject at the site.

How calculated: This calculation counts queries based on the Query Type filter specified on the report prompt page. If you choose Manual, this calculation counts only manual queries. If you choose Automatic, this calculation counts only automatic queries.

The average is calculated as follows:.

<avg queries per patient> = <query count> / <subject count>

where <total queries> = the number of automatic or manual queries, as specified in the report prompt page.


Query Count: Candidate



How calculated: This calculation counts manual, automatic, or both types of candidate queries based on the Query Type filter specified on the report prompt page.


Query Count: Deleted Data displayed: Numeric


How calculated: This calculation counts manual, automatic, or both types of deleted queries based on the Query Type filter specified on the report prompt page.


Query Count: Open Data displayed: Numeric

Description: The number of queries with a current status of open.

How calculated: This calculation counts open queries of type manual, automatic, or both, based on the Query Type filter specified on the report prompt page.


Query Count: Answered



How calculated: This calculation counts manual, automatic, or both types of answered queries based on the Query Type filter specified on the report prompt page.



Query Status by Site Column Description Query Count: Closed Data displayed: Numeric


How calculated: This calculation counts automatic, manual, or both types of closed queries, based on the Query Type filter specified on the report prompt page.


Query Count: Total (% of Total within Country)

Data displayed: Number/Percentage

Description: The total number of queries at the site, regardless of status. For each site total, this column also displays the site's percentage of total queries for the country.

How calculated: This calculation counts automatic, manual, or both types of closed queries, based on the Query Type filter specified on the report prompt page. The percentage is calculated as follows:

<% of total within country> = <query count for the site> * 100 / query count for the country>



Query Status by Site and Subject

Selection criteria: Query Status by Site and Subject Use the Query Status by Site and Subject prompt page to select criteria and specify sort options for your report.


Query Status by Site and Subject Selection criteria Action Countries Choose one of these actions::









Query Type Select one of the options below to specify whether you want the report to include either:

Auto Manual


Sort options

Query Status by Site and Subject


Second level sort: Site mnemonic




Report/Graph page: Query Status by Site and Subject This section describes the Query Status by Site and Subject report/graph page.

Subtotals and totals Subtotals— by Site and Country Totals—overall query count totals

Column descriptions

The following table describes the columns on the Query Status by Site and Subject report:

Query Status by Site and Subject Column Description Country Data displayed: String







Description: The subject number, followed by the subject initials.

The subject number automatically assigned to the subject when the subject's screening form is completed and submitted. This number, and the subject initials, can also be changed post enrollment, if configured in the trial.

Note that:





Query Status by Site and Subject Column Description Current Status Data displayed: String

Description: The current status for the subject, which must be enrolled. (This report includes data for only enrolled subjects.)


Started Visits Count Data displayed: Numeric

Description: For each subject, the number of visits that have a current status of started in InForm software.

How calculated: For each subject, a visit is counted as started if at least one expected form in the visit have been started. A form is started when any data, queries, or comments have been entered on the form.





















Query Status by Site and Subject Column Description Query Count: Closed Data displayed: Numeric




Total (% of Queries within Country)







Query Status by Site and Visit

This report shows the current total queries in each state by site and visit.

Selection criteria: Query Status by Site and Visit Use the Query Status by Site and Visit prompt page to select criteria and specify sort options for your report.


Query Status by Site and Visit Selection criteria Action Countries Choose one of these actions:









Query type Select one of the options below to specify whether you want the report to include either:

Auto Manual


Sort options

Query Status by Site and Visit

Sort Default selection First level sort: % of all Queries

Second level sort: Answered Query Count




Report/Graph page: Query Status by Site and Visit This section describes the Query Status by Site and Visit report/graph page.

Subtotals and totals Subtotals—by Site and Country Totals—overall query count totals

Column descriptions

The following table describes the columns in the Query Status by Site and Visit report:

Query Status by Site and Visit Column Description Country Data displayed: String














Query Status by Site and Visit Column Description Query Count: Candidate









Query Count: Opened Data displayed: Numeric









Query Count: Closed Data displayed: Numeric





Query Status by Site and Visit Column Description Query Count: Total (% Queries within Country)







Query Status by User

This report shows the current total queries in each state by user.

Selection criteria: Query Status by User Use the Query Status by User prompt page to select criteria and specify sort options for your report.


Query Status by User Selection criteria Action Rights groups Choose one of these actions::






Sites If you updated the Sites lists after selecting one or more users, choose one of these actions:




Auto Manual


Sort options

Query Status by User Sort Default selection First level sort: Rights Group



Query Status by User Sort Default selection Third level sort: Site Mnemonic


Report/Graph page: Query Status by User This section describes the Query Status by User report/graph page.

Subtotals and totals Subtotals—none Totals—overall query count totals

Drill down reports

This report contains links to two dill down reports:

Click the value in the site mnemonic column to drill down to the Query Status by Site and Visit report for the selected site

Click the value in Subject Count column to drill down to the Query Status by Site and Subject report for the subjects included in the count.

Column descriptions

The following table describes the columns in the Query Status by User report:


Column Description









Column Description





Description: The number of subjects who have ever participated in the study.



Tip: You can use any of the predefined subject filters to further qualify this count.

Avg Queries per Patient


Description: The average number of queries associated with each subject at the site.

How calculated: This calculation counts queries based on the Query Type filter specified on the report prompt page. If you choose Manual, this calculation counts only manual queries. If you choose Automatic, this calculation counts only automatic queries.

The average is calculated as follows:.

<avg queries per patient> = <query count> / <subject count>

where <total queries> = the number of automatic or manual queries, as specified in the report prompt page.













Column Description


Description: The number of queries that were opened in a given month.

How calculated: A query is counted if it was opened within a given month. This calculation counts queries based on the Query Status and Query State filters on the report prompt page.







Query Count: Closed Data displayed: Numeric




Query Count: Total (% of all Queries)







Query Volume by Month by Site

This report shows and plots the number of queries opened, answered, and closed in each month for a range of months.

Selection criteria: Query Volume by Month by Site Use the Query Volume by Month by Site prompt page to select criteria and specify sort options for your report.


Query Volume by Month by Site Selection criteria Action Countries Choose one of these actions:






Query status Select one or more options to filter the report to include only these queries:

Open Queries Answered Queries Closed Queries

The resulting report will include data about queries with any of these status selections specified here. If you leave all checkboxes blank, the report will include all of these options

Query state Filter the report to include data for queries in either of these states.

Candidate Queries Reissued Queries

The resulting report will be limited to queries in the state you specify. If you make no selection, the report will include both of these options


Query Volume by Month by Site Selection criteria Action Query type Select one or more options to filter the report to

include only these queries:

Auto Manual


Date range Choose one of these actions:

Specify a From and To date by entering dates, or using the calendar icons to select the date range to include in your report.

Use the Earliest Date and Latest Date radio buttons to automatically select the earliest and latest possible dates.

The resulting report will show query volume for the specified date range.

Sort options






Report/Graph page: Query Volume by Month by Site This section describes the Query Volume by Month by Site report/graph page.

Graphs A bar graph appears on the first page of the Query Volume by Month by Site report, plotting the query volume by month and site.



Column descriptions

The following table describes the columns in the Query Volume by Month by Site report.


Column Description Country Data displayed: String






Open Counts by Month Data displayed: Numeric




Answered Counts by Month


Description: The number of queries there were answered in a given month.

How calculated: A query is counted if it has been answered in a given month. This calculation counts queries based on the Query Status and Query State filters on the report prompt page.


Closed Counts by Month


Description: For each site, the number of queries that were closed in a given month.

How calculated: A query is counted if l it has a status of closed in a given month. This calculation counts queries based on the Query Status and Query State filters on the report prompt page.




Column Description Totals by Month Data displayed: Numeric

Description: For each site, the total number of open and answered queries in a given month.

How calculated: The value displayed in this column is the sum of the values in the Open and Ans'd columns.



Query Volume by Month by User

This report shows and plots the number of queries opened, answered, and closed in each month for a range of months.

Selection criteria: Query Volume by Month by User prompt page Use the Query Volume by Month by User prompt page to select criteria and specify sort options for your report.


Query Volume by Month by User Selection criteria Action Rights groups Choose one of these actions::






Sites If you updated the Sites lists after selecting one or more users, choose one of these actions:



Query status Select one or more options to filter the report to include only these queries:

Open Queries Answered Queries Closed Queries


Query state Select one or more options to filter the report to include only these queries:

Candidate Queries Reissued Queries

If you leave all checkboxes blank, the report will include both of these options


Query Volume by Month by User Selection criteria Action Query type Select one or more options to filter the report to include only

these queries:

Auto Manual


Date range Specify a From and To date by entering dates, or using the calendar icons to select the date range to include in your report.

The resulting report will show query volume for the specified date range.

Sort options







Report/Graph page: Query Volume by Month by User This section describes the Query Volume by Month by User report/graph page.

Subtotals and totals Subtotals— none Totals—overall query count totals

Column descriptions

The following table describes the columns in the Query Volume by Month by User report:


Column Description







Open counts by Month Data displayed: Numeric




Answered counts by Month







Column Description

Closed counts by Month





Totals Data displayed: Numeric

Description: The total number of open, answered, and closed queries for each month

How calculated: For each site, this calculation adds open, answered, and closed queries for each month.



Query Volume by Rule

This report shows the number of times each rule has been triggered, as well as the percentage relative to all triggered rules.

Selection criteria: Query Volume by Rule report Use the Query Volume by Rule prompt page to select criteria and specify sort options for your report.


Query Volume by Rule Selection criteria Action Rule trigger count Select a trigger count range for your report. The

trigger count reflects how many times a rule triggered a query in InForm software.

Use the radio buttons to choose these actions::

Specify a From and To value Use the Lowest value and Highest value to

select the lowest and highest trigger counts in the study.

Sort options


Sort Default selection First level sort: Trigger Count

Second level sort: Form Mnemonic




Report/Graph page: Query Volume by Rule This section describes the Query Volume by Rule report/graph page.

Graphs

A bar graph appears on the first page of the Query Volume by Rule report, illustrating the number of times each rule triggered a query.

Subtotals and totals Subtotals— by Rule Totals—overall rule trigger count totals

Column descriptions

The following table describes the columns in the Query Volume by Rule report.


Column Description

Rule name Data displayed: String

Description: The name that uniquely identifies the rule in the trial design code.


Form Mnemonic Data displayed: String



Item Name Data displayed: String

Description: The name that uniquely identifies the item to which the rule is attached in the trial design code.


Trigger Count Data displayed: Text

Description: The total number of rules that have been triggered in InForm software.

How calculated: A rule is counted if it has been triggered.



Subject Counts with Outstanding Queries

This report shows the number of subjects at each site that have open or answered queries at a specified time.

Selection criteria: Subject Counts with Outstanding Queries report Use the Subject Counts with Outstanding Queries prompt page to select criteria and specify sort options for your report.


Subject Counts with Outstanding Queries Selection criteria Action Countries Choose one of these actions:






Query Type Select one or more options to filter the report to include only these queries:

Auto Manual


Minimum Days 'Open' or 'Answered'

Specify the minimum number of days a query must be opened or answered to be included in this report.

Sort options







Report/Graph page: Subject Counts with Outstanding Queries This section describes the Subject Counts with Outstanding Queries report/graph page.

Subtotals and totals Subtotals— by Country Totals—overall subject count totals

Column descriptions

The following table describes the columns in the Subject Counts with Outstanding Queries report:


Column Description Country Data displayed: String






Subjects Data displayed: Numeric




Subjects with Open Queries


Description: The number of subjects with open queries

How calculated: A subject is counted if there is at least one open query against the data entered for the subject. The open query must have been open for at least the number of days specified in the Minimum Days Opened or Answered filter on the report prompt page.




Column Description Subjects with Answered Queries


Description: The number of subjects with answered queries

How calculated: A subject is counted if there is at least one answered query against the data entered for the subject. The open query must have been answered for at least the number of days specified in the Minimum Days Opened or Answered filter on the report prompt page.


281

Subject reports provide information on the progress of casebook completion for individual subjects. These reports also provide subject enrollment and dropout counts, as well as subject enrollment status.

In This Chapter Case Book Completion and Query Summary by Site ..282 Case Book Completion and Query Summary by User.287 Cumulative Subject Enrollment by Month ....................292 Subject Dropout Count by Reason...............................295 Subject Enrollment Status by Site................................298 Subject Enrollment Status by User ..............................303

C H A P T E R 1 0

Subject reports


Case Book Completion and Query Summary by Site

This report shows how many subject case books are complete and how many have no outstanding queries.

Selection criteria: Case Book Completion and Query Summary by Site report Use the Case Book Completion and Query Summary by Site prompt page to select criteria and specify sort options for your report.


Case Book Completion and Query Summary by Site Selection criteria Action Countries Choose one of these actions:






Expected forms Filter the report by expected forms. Choose one of these options from the drop-down list.







Chapter 10 Subject reports 283

Sort options

Case Book Completion and Query Summary by Site




Use the sort drop-down boxes to change these selections.

Report/Graph page: Case Book Completion and Query Summary by Site This section describes the Case Book Completion and Query Summary by Site report/graph page.

Subtotals and totals Subtotals—by Country Totals—overall subject count totals

Column descriptions

The following table describes the Case Book Completion and Query Summary by Site report:

Case Book Completion and Query Summary by Site Column Description Country Data displayed: String







Case Book Completion and Query Summary by Site Column Description Enrolled Subject Count Data displayed: Numeric

Description: The number of subjects who have enrolled at the site, and not dropped out.

How calculated: For each site, a subject is counted if the subject has been enrolled in InForm software and has not dropped out of the study.


Incomplete CRBs Data displayed: Numeric

Description: The number of started CRBs that are not complete.

How calculated: A case book is counted if it has been started and at least one expected form does not have a status of Data Entry Completed.

This value displays as both a total and a percentage of started CRBs that are not complete:

<% incomplete CRBs> = <incomplete CRBs> * 100 / <started CRBs>


Incomplete CRBs with Queries


Description: The number of started CRBs that are not complete and that have open queries.

How calculated: A case book is counted if it meets all of the following criteria:

it has been started at least one expected form does not have a status of Data

Entry Completed at least one expected form has at least one open or

answered query


Incomplete CRBs without Queries


Description: The number of started CRBs that are not complete and that have no open queries.


it has been started at least one expected form does not have a status of Data

Entry Completed no expected forms have any open or answered queries

<Incomplete CRBs w/out queries> = <Incomplete CRBs> - <Incomplete CRBs with Queries>



Case Book Completion and Query Summary by Site Column Description Completed CRBs Data displayed: Numeric

Description: The number of started CRBs that are complete.


it has been started all expected forms have a status of Data Entry Completed

<complete CRBs > = < CRB count> - <Incomplete CRBs >

This value displays as both a total and as percentage of all started CRBs that are complete:

<% complete CRBs> = <complete CRBs> * 100 / <started CRBs>


Completed CRBs with Queries


Description: The number of started CRBs that are complete and that have open or answered queries.


it has been started all expected forms have a status of Data Entry Completed at least one expected form has at least one open or

answered queries

<CRBs with queries > = < incomplete CRBs with queries>

This value displays as both a total and as percentage of all started CRBs that are complete and have queries::

<% complete CRBs w/queries> = <complete CRBs w/ queries> * 100 / <started CRBs>



Case Book Completion and Query Summary by Site Column Description Completed CRBs without Queries


Description: The number of started CRBs that are complete and that have no open or answered queries.


it has been started all expected forms have a status of Data Entry Completed no expected forms have any open or answered queries

<complete CRBs w/out queries > = <Complete CRBs> - < complete CRBs with queries>

This value displays as both a total and as percentage of all started CRBs that are complete and have no queries:

<% complete CRBs w/out queries> = <complete CRBs w/out queries> * 100 / <started CRBs>



Case Book Completion and Query Summary by User

This report shows how many subject case books are complete and how many have no outstanding queries.

Selection criteria: Case Book Completion and Query Summary by User report Use the Case Book Completion and Query Summary by User prompt page to select criteria and specify sort options for your report.


Case Book Completion and Query Summary by User Selection criteria Action Rights Groups .Select the rights group or groups used for CRAs that are






Expected forms Filter the report by expected forms. Choose one of these options from the drop-down list.








Sort options

Case Book Completion and Query Summary by User

Sort Default selection First level sort: Group Name




Report/Graph page: Case Book Completion and Query Summary by User This section describes the Case Book Completion and Query Summary by User report/graph page.

Subtotals and totals Subtotals—by User and Rights Group Totals—overall subject count totals

Column descriptions

The following table describes the columns in the Case Book Completion and Query Summary by User report:

Case Book Completion and Query Summary by User Column Description Rights Group Data displayed: String










Case Book Completion and Query Summary by User Column Description Enrolled Subject Count Data displayed: Numeric




Incomplete CRBs Data displayed: Numeric

Description: The number of started CRBs that are not complete.

How calculated: A case book is counted if it has been started and at least one expected form does not have a status of Data Entry Completed.

This value displays as both a total and a percentage of started CRBs that are not complete:

<% incomplete CRBs> = <incomplete CRBs> * 100 / <started CRBs>


Incomplete CRBs with Queries


Description: The number of started CRBs that are not complete that have open or answered queries.

How calculated: A case book is counted if it meets both of the following criteria:

it has been started and at least one expected form does not have a status of Data Entry Completed

at least one expected form has at least one open or answered query

This value displays as both a total and a percentage of all started CRBs that are incomplete and that have queries:

<% incomplete CRBs with queries>=<incomplete CRBs with queries> * 100/ <started CRBs>



Case Book Completion and Query Summary by User Column Description Incomplete CRBs without Queries


Description: The number of started CRBs that are not complete that have no open or answered queries.

How calculated: A case book is counted if it meets both of the following criteria:

it has been started and no expected forms have a status of Data Entry Completed

no expected form have any open or answered queries

This value displays as both a total and a percentage of started CRBs that are incomplete and have no queries:

<% incomplete CRBs w/out queries> = <incomplete CRBs w/out queries> * 100 / <started CRBs>


Completed CRBs Data displayed: Numeric

Description: The number of started CRBs that are complete.


it has been started all expected forms have a status of Data Entry Completed

<complete CRBs > = < CRB count> - <Incomplete CRBs >

This value displays as both a total and as percentage of all started CRBs that are complete:

<% complete CRBs> = <complete CRBs> * 100 / <started CRBs>


Completed CRBs with Queries


Description: The number of started CRBs that are complete and that have open or answered queries.


it has been started all expected forms have a status of Data Entry Completed at least one expected form has at least one open or

answered queries

<CRBs with queries > = < incomplete CRBs with queries>

This value displays as both a total and as percentage of all started CRBs that are complete and have queries::

<% complete CRBs w/queries> = <complete CRBs w/ queries> * 100 / <started CRBs>



Case Book Completion and Query Summary by User Column Description Completed CRBs without Queries


Description: The number of started CRBs that are complete and that have no open or answered queries.


it has been started all expected forms have a status of Data Entry Completed no expected forms have any open or answered queries

<complete CRBs w/out queries > = <Complete CRBs> - < complete CRBs with queries>

This value displays as both a total and as percentage of all started CRBs that are complete and have no queries:

<% complete CRBs w/out queries> = <complete CRBs w/out queries> * 100 / <started CRBs>



Cumulative Subject Enrollment by Month

This report charts the cumulative counts of enrolled, dropped, and completed subjects over time.

Selection criteria: Cumulative Subject Enrollment by Month report Use the Cumulative Subject Enrollment by Month prompt page to select criteria and specify sort options for your report.


Cumulative Subject Enrollment by Month Selection criteria Action Countries Choose one of these actions:






Date range Specify a From and To date by entering dates or by using the calendar icons to select the date range to include in your report.

Sort options

Cumulative Subject Enrollment by Month

Sort Default selection First level sort: Site Mnemonic

Second level sort: Date



Report/Graph page: Cumulative Subject Enrollment by Month This section describes the Cumulative Subject Enrollment by Month report/graph page.

Graphs A bar graph appears on the first page of the Cumulative Subject Enrollment by Month report, illustrating the enrolled, dropped, and completed subject count by month.

Subtotals and totals Subtotals— none Totals—overall subject count totals

Column descriptions

The following table describes the columns on the Cumulative Subject Enrollment by Month report.

Cumulative Subject Enrollment by Month Column Description Site Mnemonic Data displayed: String



Enrolled count by month


Description: The number of subjects who were enrolled at the site within a given month.

How calculated: For each site, the enrolled subject count is incremented if a new subject has become enrolled during the month. If there are no new subjects enrolled during a particular month, the count is the same as the previous month.


Dropped count by month


Description: The number of subjects in each site who dropped out of the study during a given month.

How calculated: For each site and month, the dropped subject count is incremented if a subject drops out of the study during the month. If no subjects drop out during a particular month, the count is the same as the previous month.



Cumulative Subject Enrollment by Month Column Description Completed count by month


Description: The number of subjects at the site who completed the study during a given month.

How calculated: For each site and month, the complete subject count is incremented when a subject completes the study in a particular month. If no subjects complete the count in a given month, the count is the same as the previous month.



Subject Dropout Count by Reason

This report shows the number of subjects who have left the study for each reason used in the trial design.

Selection criteria: Subject Dropout Count by Reason report Use the Subject Dropout Count by Reason prompt page to select criteria and specify sort options for your report.










Sort options







Report/Graph page: Subject Dropout Count by Reason This section describes the Subject Dropout Count by Reason report/graph page.

Graphs

A bar graph appears on the first page of the Subject Dropout Count by Reason report, illustrating how many subjects dropped out by drop out reason.

Subtotals and totals Subtotals— by Country and Site Totals—overall subject count totals

Column descriptions

The following table describes the Subject Dropout Count by Reason report.

Subject Dropout Count by Reason Column Description Country Data displayed: String









Note that:

Subject number may or may not be unique at your site The subject number field is called Patient Number in the InForm

user interface.




Subject Dropout Count by Reason Column Description Dropout Reason Data displayed: String

Description: Text that indicates why the subject dropped out of the study in InForm software. The drop out reason is clinical data that is specified on the Study Completion form for the subject.

Note: This report displays only those reasons that were specified when subjects dropped out of the study. If a drop out reason was never used, it does not appear in this report.



Subject Enrollment Status by Site

Selection criteria: Subject Enrollment Status by Site Use the Subject Enrollment Status by Site prompt page to select criteria and specify sort options for your report.










Sort options






Report/Graph page: Subject Enrollment Status by Site This section describes the Case Book Completion and Query Summary by Site report/graph page.

Graphs A bar graph appears on the first page of the Case Book Completion and Query Summary by Site report, illustrating the number of enrolled subjects at each site.


Subtotals and totals Subtotals—by Country Totals—overall subject count totals

Column descriptions

The following table describes the columns in the Case Book Completion and Query Summary by Site report.

Subject Enrollment Status by Site Column Description Country Data displayed: String







Description: The number of subjects who have ever been successfully screened in InForm software.

How calculated: For each site, a subject is counted if he/she has been assigned a screened status in InForm software in the date range specified on the report prompt page. A subject is screened if:


The subject is fully screened and the enrollment process has started but not completed


Screen Failure Data displayed: Numeric

Description: The number of subjects who have failed the screening process in InForm software.

How calculated: For each site, a subject is counted if the subject failed the InForm screening process within the date range specified on the report prompt page. Note that this count includes subjects whose screen failure has been overridden in InForm software.



Subject Enrollment Status by Site Column Description Enroll Failure Data displayed: Numeric

Description: The number of subjects who have failed the enrollment process in InForm software.

How calculated: For each site, a subject is counted if he/she failed the InForm enrollment process within the date range specified. Note that this count includes subjects whose enrollment failure has been overridden in InForm software.


Screen Override Data displayed: Numeric

Description: For each site, the number of subjects who have been screened in InForm software due to the screening override process within the date range specified on the report prompt page.

How calculated: For each site, a subject is counted if he/she has ever failed the InForm screening process, but has subsequently been screened through the InForm screening override process. Note that this count includes subjects who may have moved on to other states, such as enrolled, randomized, dropped out, or complete.

Subjects screened and enrolled through PF Admin Import: Subjects who are added to the trial through PF Admin Import are never counted in Screen/Enroll Override counts, even if they initially failed screening or enrollment.


Enroll Override Data displayed: Numeric

Description: For each site, the number of subjects who have been enrolled in InForm software due to the enrollment override process within the date range specified on the report prompt page.

How calculated: For each site, a subject is counted if he/she has ever failed the InForm enrollment process, but has subsequently been enrolled through the InForm enroll override process. Note that this count includes subjects who may have moved on to other states, such as randomized, dropped out, or complete.




Subject Enrollment Status by Site Column Description Enrolled (% of Screened + Screen Override)


Description: The number of subjects that have been enrolled at the site.

How calculated: For each site, a subject is counted if he/she has ever enrolled in the study in InForm software Note that this count includes subjects who may have moved on to other states, such as randomized, dropped out, or complete. It also includes subjects who may have failed screening and enrollment, but were later enrolled through the screening/enrollment override process.

Subjects screened and enrolled via PF Admin Import: Subjects who are added to the trial via PF Admin Import are never counted in Screen/Enroll Override counts, even if they initially failed screening or enrollment.

This value appears as a whole number and as the percentage of total subjects who have been screened and have gone through the screening/enrollment override process (this should always equal 100%):

<% enrolled> = <enrolled subjects> * 100 / [<screened subjects + screened override subjects>]


Randomized (% of Enrolled)


Description: The number of enrolled subjects who have been randomized in InForm software within the date range specified on the report prompt page.

How calculated: For each site, a subject is counted if he/she has ever been in the randomized state in Inform software within the date range specified on the report prompt page.

This value appears as a whole number and as a percentage of all enrolled subjects who've been randomized:

<% randomized> = <randomized subjects> * 100 / <all subjects who have ever been enrolled>



Subject Enrollment Status by Site Column Description Active in Trial (% of Enrolled)


Description: For each site, the number of subjects currently participating in the trial.

How calculated: For each site, a subject is counted if he/she has been enrolled in InForm screening and has not yet dropped out or completed the trial.

This value displays as a whole number and as the percentage of all subjects that have ever been enrolled who are currently active:

<% active in trial> = <subjects with a current status of enrolled or randomized> * 100 / <all subjects who have ever been enrolled>


Completed (% of Enrolled)


Description: The number of enrolled subjects who have completed the trial.

How calculated: For each site, a subject is counted if he/she has completed the study, as recorded on the subject completion n Inform software.

This value appears as a whole number and as a completed percentage of all enrolled subjects who've been enrolled for each site:

<% completed> = <randomized subjects> * 100 / <all subjects who have ever been enrolled>


Dropped (% of Enrolled)


Description: The number of enrolled subjects who have dropped out of the trial.

How calculated: For each site, a subject is counted if he/she has dropped out of the study, as recorded on the subject completion form in Inform software.

This value appears as a whole number and as a completed percentage of all dropped out subjects who've been enrolled for each site:

<% dropped out= <dropped out subjects> * 100 / <all subjects who have ever been enrolled>



Subject Enrollment Status by User

Selection criteria: Subject Enrollment Status by User Use the Subject Enrollment Status by User prompt page to select criteria and specify sort options for your report.



Selection criteria Action Rights groups Select the rights group or groups used for CRAs that are

primary in your study. Click Update after your selection to update the Users list. .






Sort options


Sort Default selection First sort: Rights Group

Second sort: User Name

Third sort: Site Mnemonic



Report/Graph page: Subject Enrollment Status by User This section describes the Subject Enrollment Status by User report/graph page.

Subtotals and totals Subtotals—none Totals—overall subject count totals

Column descriptions

The following table describes the columns in the Subject Enrollment Status by User report:

Subject Enrollment Status by User Column Description Rights Group Data displayed: String










Description: The number of subjects who have ever been successfully screened in InForm software.

How calculated: For each site, a subject is counted if he/she has been assigned a screened status in InForm software in the date range specified on the report prompt page. A subject is screened if:


The subject is fully screened and the enrollment process has started but not completed



Subject Enrollment Status by User Column Description Screen Failure Data displayed: Numeric

Description: The number of subjects who have failed the screening process in InForm software.

How calculated: For each site, a subject is counted if the subject failed the InForm screening process within the date range specified on the report prompt page. Note that this count includes subjects whose screen failure has been overridden in InForm software.


Enroll Failure Data displayed: Numeric

Description: The number of subjects who have failed the enrollment process in InForm software.

How calculated: For each site, a subject is counted if he/she failed the InForm enrollment process within the date range specified. Note that this count includes subjects whose enrollment failure has been overridden in InForm software.


Screen Override Data displayed: Numeric

Description: For each site, the number of subjects who have been screened in InForm software due to the screening override process within the date range specified on the report prompt page.

How calculated: For each site, a subject is counted if he/she has ever failed the InForm screening process, but has subsequently been screened through the InForm screening override process. Note that this count includes subjects who may have moved on to other states, such as enrolled, randomized, dropped out, or complete.




Subject Enrollment Status by User Column Description Enroll Override Data displayed: Numeric

Description: For each site, the number of subjects who have been enrolled in InForm software due to the enrollment override process within the date range specified on the report prompt page.

How calculated: For each site, a subject is counted if he/she has ever failed the InForm enrollment process, but has subsequently been enrolled through the InForm enroll override process. Note that this count includes subjects who may have moved on to other states, such as randomized, dropped out, or complete.



Enrolled (% of Screened + Screen Override)


Description: The number of subjects that have been enrolled at the site.

How calculated: For each site, a subject is counted if he/she has ever enrolled in the study in InForm software Note that this count includes subjects who may have moved on to other states, such as randomized, dropped out, or complete. It also includes subjects who may have failed screening and enrollment, but were later enrolled through the screening/enrollment override process.

Subjects screened and enrolled via PF Admin Import: Subjects who are added to the trial via PF Admin Import are never counted in Screen/Enroll Override counts, even if they initially failed screening or enrollment.

This value appears as a whole number and as the percentage of total subjects who have been screened and have gone through the screening/enrollment override process (this should always equal 100%):

<% enrolled> = <enrolled subjects> * 100 / [<screened subjects + screened override subjects>]



Subject Enrollment Status by User Column Description Randomized (% of Enrolled)


Description: The number of enrolled subjects who have been randomized in InForm software within the date range specified on the report prompt page.

How calculated: For each site, a subject is counted if he/she has ever been in the randomized state in Inform software within the date range specified on the report prompt page.

This value appears as a whole number and as a percentage of all enrolled subjects who've been randomized:

<% randomized> = <randomized subjects> * 100 / <all subjects who have ever been enrolled>


Active in Trial (% of Enrolled)


Description: For each site, the number of subjects currently participating in the trial.

How calculated: For each site, a subject is counted if he/she has been enrolled in InForm screening and has not yet dropped out or completed the trial.

This value displays as a whole number and as the percentage of all subjects that have ever been enrolled who are currently active:

<% active in trial> = <subjects with a current status of enrolled or randomized> * 100 / <all subjects who have ever been enrolled>


Completed (% of Enrolled)


Description: The number of enrolled subjects who have completed the trial.

How calculated: For each site, a subject is counted if he/she has completed the study, as recorded on the subject completion n Inform software.

This value appears as a whole number and as a completed percentage of all enrolled subjects who've been enrolled for each site:

<% completed> = <randomized subjects> * 100 / <all subjects who have ever been enrolled>



Subject Enrollment Status by User Column Description Dropped out (% of Enrolled)


Description: The number of enrolled subjects who have dropped out of the trial.

How calculated: For each site, a subject is counted if he/she has dropped out of the study, as recorded on the subject completion form in Inform software.

This value appears as a whole number and as a completed percentage of all dropped out subjects who've been enrolled for each site:

<% dropped out= <dropped out subjects> * 100 / <all subjects who have ever been enrolled>


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If you are a Phase Forward customer with a maintenance agreement, you can contact the Global Support Center for assistance with product, user management, provisioning, site assessment, or technical issues.

Your maintenance agreement indicates the type of support you are eligible to receive and describes how to contact Phase Forward. Additionally, the Phase Forward website lists the toll-free support number for your product, location, and support level: http://www.phaseforward.com/support_contacts.html

In the event that our toll-free telephone service is interrupted, please use either of the following methods to contact the Global Support Center:

Email [email protected]

Telephone In the US: 781-902-4900

Outside of the US: +44 (0) 1628 640794

C H A P T E R 1 1

If you need assistance


A

Ad Hoc Reporting

The InForm Reporting and Analysis module that allows you to create, run, and save your own customized reports on both clinical and trial-management data. Note that InForm Software provides ad hoc reporting capabilities using the Cognos Query Studio application.

answered query

A query in the answered state, after a site user has responded to it and before it has been verified by a sponsor representative.

automatic query

A query generated automatically by InForm software when a submitted data item fails an edit check.

C

candidate query

A preliminary query in the candidate state. Candidate queries are visible to sponsor users but are not visible to site users.

check box

A type of data entry control in which a user can specify one or more selections by checking the box that represents each selection:

clinical data

Data used to record specifics of a subject's visit.

clinical reporting package

An Ad Hoc Reporting package that provides access to both clinical and trial-management data for reporting. Clinical reporting packages are unique for each trial.

Glossary

Chapter 11 Glossary 311

complete form

In reporting, a form is counted as complete if it is expected and meets the following criteria:

It is started

All required items contain data

No open queries are associated with any items on the form

complete visit

In reporting, a visit is counted as complete if all of the expected forms in the visit have a current status of complete.

Visit status reported in InForm Reporting and Analysis differs from visit status indicated by the traffic light icon in the InForm interface.

Visit complete in InForm Reporting and Analysis —All expected forms must be complete for the visit to be considered complete.

Visit complete in InForm interface—At least one started form must be complete for the visit to be considered complete.

common form

A type of CRF containing data that is cumulative from visit to visit. Each time the form occurs in a visit, it displays the accumulated data from all previous visits in which you collected that data, and you can add to the data in the current visit.

content pane

The right side of the InForm software window, displaying screens such as CRFs, summary lists, and CRF item details.

content-specific pane

The bar at the bottom of each InForm software page, displaying command buttons and navigation controls that initiate actions. The contents of this pane vary depending on what is displayed in the content pane.

CRF help

A study document containing details about how to supply information for CRF items. CRF help can be linked to individual CRFs or CRF items, so that you can click the item text and display the corresponding CRF help entry.

D

Data model

A data model is a layer of the reporting database that describes the data objects, structure, grouping, data relationships, and security. InForm Reporting and Analysis uses one or more data models to make the data in the InForm Reporting Database available for your reports.


Two data models exist for every InForm trial: the trial management model and the trial-specific clinical model.

A data model is internal to the system; it is not directly visible to you until it is published to a package.

E Expected forms

A form is counted as expected if it meets any of these criteria:


It appears within a started unscheduled visit

It is a dynamic form that has been activated














F

FAQ

Frequently Asked Question, a supplemental entry in CRF help to provide additional clarification on a CRF item.

filter

A mechanism for selecting specific types of information from a long listing; for example, the Query Listing. Filters consist of pull-down lists from which you can select the types of list items you want to display.

form indexer

A multi-part control that appears on the title bar of a form on some InForm software screens. By clicking different parts of the control, you can move through the individual forms of a repeating form.

H

home page

The page that appears when you initially log in to InForm software.

I

icon

A small graphic symbol that provides a link to additional information or functionality. In InForm software, the traffic light icons supply status information as well as enabling you to link to the information that they represent.


A reporting application, developed by Cognos Corporation, which has been customized and integrated into InForm software by Phase Forward, Incorporated.

InForm Trial Management package

An Ad Hoc Reporting package that provides access to trial management data for reporting. Reports created with the InForm Trial Management package can be shared across trials.


item

A single unit of data captured on a CRF. Each unit is identified by an Item Number.

itemset

A collection of related CRF items that repeat. Each set of items takes one row on the CRF. The following example illustrates three itemsets:

M

manual query

A query that is issued manually by using the Query page.

Most Recently Used list

A list of the four most recently visited pages, appearing in the lower left corner of the navigation pane. To return to one of these screens, click its name in the list.

N

navigation pane

The left side of the InForm software window, displaying navigation buttons that you use to enter the various functional areas of InForm software.

O

opened query

A query in the opened state, visible to the site and available for response.


P

package

A grouping of data from one or more data models, used for reporting. Two reporting packages are installed with every InForm trial: the InForm Trial Management package and a trial-specific clinical package.

page indexer control

A control that appears at the bottom of screens that include lists covering more than one page of data. The page indexer control enables you to move from page to page sequentially or to jump to a specific page.

pulldown list

A type of data entry control that enables you to select a single item from a list.

R

radio button

A type of data entry control in which you must select a single item by clicking a button resembling a radio dial.

regular form

A CRF used to collect data that is specific to the visit in which the form occurs.

S

Select Action list

The Select Action list appears on the content-specific pane of a CRF along with a Do button. Appearing next to buttons that reflect the tasks you are most likely to perform, this list contains additional actions that your rights allow you to do: for example, Print Preview, Mark SV Ready, Clear CRF, Freeze Visit.

To use the Select Action list, select an action and then click Do.


signature group

A group of users who are authorized to sign a specific set of CRFs. Each CRF that requires signing must be signed by one member of each signature group with which it is associated.

Standard Reports

Reports included with each InForm Reporting and Analysis installation.

Started form

In reporting, a form is counted as started if a user submitted the form or the form has data, a query, or a comment.

Started visit

In reporting, visit is counted as started if at least one non-common expected form in the visit has been started.

SV Report

A listing of a single CRF or of all CRFs, used for source verification when the source documents in a location that makes it inconvenient or impossible to perform source verification online.

T

text box

A type of data entry control in which you type the data.

trial management data

Metric and status data pertaining to the study. Using trial management data, you can report on the status of your study relative to its completion.

U

unscheduled visit

A visit that occurs in addition to the visits prescribed by the study protocol. In InForm software, unscheduled visits are added to the end of the patient’s Case Book as they occur.

V

visit calculator

A simple scheduling aid that enables you to compute and print out suggested visit dates based on the patient’s start date. The visit calculator page appears when you enroll a patient and is also available as part of the trial’s study documents.

319

A About the trial-specific clinical package • 116 ad hoc reporting

ad hoc reporting overview • 26 clinical package • 11 how to access • 27 InForm Trial Management package • 13 reporting tree • 28

automatic summarization, turning off • 23

C clinical package • 11 CRF Aging by Site report • 158 CRF Aging by User report • 163 CRF Cycle Time Detail by Site report • 168 CRF Cycle Time Detail by User report • 173 CRF Item Listing • 218 CRF Site Performance Summary by Site report •

179 CRF Site Performance Summary by User report

• 184 CRF Status Detail by Site and Subject report •

189 CRF Status Detail by Visit and Site report • 196 CRF Status Summary by Site report • 203 CRF Status Summary by User report • 210

D data, about • 152 database, reporting • 8

F forms, expected • 72

H help, reporting • 7

I InForm Trial Management package • 13

O Outstanding Queries by Site and Visit report •

230

P package • 11, 13

Q Query Aging by Site report • 233 Query Cycle Times by Site report • 236 Query Cycle Times by User • 240 Query Performance Summary by Site • 244 Query Performance Summary by User • 248 Query Status by Site • 252 Query Status by Site and Subject • 256 Query Status by User report • 264 Query Volume by Month by Site • 268 Query Volume by Rule report • 276

R report elements

comments • 105 filters • 112 forms • 65 user info • 99

reporting and trial design DOV control • 15 DOV control and reporting • 14 labels for clinical elements • 15 optional trial elements • 14 using calculation and conversion rules • 16

reporting database • 8 reporting portal • 18 reporting tree • 10 reports • 158, 163, 168, 173, 179, 184, 189, 196,

203, 210, 218, 230, 233, 236, 240, 244, 248, 256, 260, 264, 268, 272, 278, 282, 287, 292, 295, 298, 303 automatic summarization, turning off • 23 running • 20, 21, 22 running in a separate window • 20 scheduling • 23

S Source Verification Listing report • 224 Standard reports

report/graph page • 150 Subject Counts with Outstanding Queries report

• 278

Index

320 Index

Subject Dropout Count by Reason report • 295 Subject Enrollment Status by Site report • 298 Subject Enrollment Status by User • 303

T trial management data • 27, 39, 109

inform reporting and analysis - harvard university

Documents