module 5 cris administrative...cris manual of operation april 2012 3 section 1‐ overview this...

CRIS Manual of Operation April 2012

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MODULE 5

CRIS ADMINISTRATIVE


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Table of Contents

CRIS Administrative Error! Bookmark not defined.

Section 1‐ Overview 3

Definitions 3

Section 2 ‐ User Account Creation and Management 3

LimeSurvey 3

Creating an Individual User 3

Creating User Groups 5

Managing Users and User Groups 7

C3PR 9

Creating a Research Staff User Account 10

Managing Research Staff 14

Section 3 ‐ Report Generation 16

LimeSurvey 16

Generating Response Reports 16

C3PR 18

Generating Study Registration Reports 18

Section 4 ‐ C3PR Study Management 20

Creating a New Study 20

Entering Details About the Study 20

Adding Consents to a Study 23

Adding Epochs and Arms to a Study 24

Determining Eligibility for a Study 26

Adding Questions for Stratification Factors 28

Reviewing the Study Overview 29

Managing an Existing Study 30

Editing an Existing Study 30

Managing Studies from the Summary Page Task Bar 32

Managing Studies from the Summary Page Icon Bar 39

Appendix A C3PR Roles and Descriptions 48


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Section 1‐ Overview This module outlines how the administrator will create and manage user accounts, generate reports,

and manage studies for CRIS applications. Each of these tasks is a section within this module that is

further divided into step by step instructions based on the specific CRIS software application.

Definitions Definitions can be found in the respective software modules.

Section 2 ‐ User Account Creation and Management The following section outlines the user account creation and management functionality of CRIS

applications.

LimeSurvey Security rights can be assigned to individual or groups of users in LimeSurvey. The following security

groups have been created for the Nation Children’s Study (NCS). Detailed LimeSurvey group permissions

are discussed later in this section.

NCS Survey Admin: NCS Survey Admin users have access to all LimeSurvey functionality,

reserved for survey administrators (i.e. Informatics developers, CRIS user assignment).

Data Collectors : Data Collectors have access to token and response creation/review only.

Data Quality: Data Quality users have access to token and response review, and response edit,

and able to generate survey reports for statistical/quality analysis.

New users must be created in both LimeSurvey Test and Production. Users will receive a confirmation

email once they have been created.

Creating an Individual User

1. Click Create/Edit Users icon located in the Administration toolbar on the main page.

2. Enter the information listed below for local domain users in the Add User section at the bottom

of the page:

a. Username

b. Email: email address

c. Full Name: user’s full name


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3. Click Add User. A confirmation page will display the username and email address of the new

user.

4. Click Set user permissions to set appropriate user permissions for the user that was just added

from the confirmation page to set user permissions.

a. Click in the box that corresponds to the access rights given to that user.

b. Click the Save now button to save the user rights.

5. Click Continue to return to the Create/Edit users page.

a. Click Set User Rights icon from the Action column to set user permissions

from this page.


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b. Click in the box that corresponds to the access rights given to that user.

c. Click the Save now button to save the user rights.

Creating User Groups

Once individual users are created, the administrator can create user groups. The three LimeSurvey NCS

user groups and the appropriate permissions by group are listed below:

NCS Survey Admin: NCS Survey Admin users have access to all LimeSurvey functionality. This

designation is typically reserved for survey administrators (i.e. Informatics developers, CRIS user

assignment). See NSC Survey Admin permissions below:

Data Collectors: Data Collectors have access to token and response creation/review only. See data

collector permissions below:


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Data Quality: Data Quality users have access to token and response review, as well as response edit.

Additionally, these users are able to generate survey response reports for statistical/quality analysis. See

data quality permissions below:

1. Click Create/Edit Groups icon located in the Administration toolbar on the main page.


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2. Click Add new user group icon in the Administration toolbar.

3. Enter the group name (required), and the description of the group (if desired), and then click

Add group when completed.

4. Select users from the dropdown list to add to the group, then click Add user.

5. Repeat this process until all users are added to the group.

Managing Users and User Groups

The administrator has the ability to manage survey permissions for an individual or a group.


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1. Click the drop‐down menu box next to the word Surveys on the Administration toolbar, to

select the survey instrument to be managed.

2. Hover the cursor over the Survey properties icon and click on Survey Permissions, located as a

drop‐down menu on the Survey toolbar:

a. For an individual, select the individual user from the User drop‐down menu on the

Survey Permissions page, and then click Add user.

b. For a group, select the user group from the Groups drop‐down menu and then click Add

user group.

3. Click edit icon located in the Action column to edit information about an existing user.


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a. From the Edit Survey Permissions page, edit the appropriate permissions and click Save

now, to save the changes to the survey permissions.

Note:

An example of a user in the Data Collectors user group is displayed above. See section labeled Managing Users and User Groups for breakdown of LimeSurvey user group permissions.

4. Click delete icon located in the Action column to delete an existing user:

C3PR C3PR functionality outlined in this document was obtained in April, 2012 from the C3PR user guide

(version 2.9.1) located on the National Cancer Institute Wiki:

https://wiki.nci.nih.gov/display/C3PR/C3PR+2.9.1+End+User+Guide

C3PR allows for the creation and management of research staff user accounts. To get started, log in to


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the CRIS portal and select the C3PR Module link from the landing page.

Creating a Research Staff User Account

1. Click Persons & Organizations tab, followed by the Research Staff icon from the C3PR home

screen.

2. Click Create Research Staff icon to display the Research Staff User Account page:


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3. Enter research staff information in the Basic Details section.

a. First Name b. Middle Name, if desired c. Last Name d. Maiden Name e. Assigned Identifier, if desired, this is the identifier assigned to a NCS Investigator. f. Email g. Phone number in the format ########## or ####### h. Fax number, if desired, in the format ########## or #######

4. Enter the research staff C3PR login Username in the Account Information section.

a. Click in the box next to Access to all sites for all roles to grant a user access to all sites

for all roles.

5. Enter the organization associated with the user in the Organizations text field.

a. Enter a partial or complete name of the organization.

Note: See recommended access in the following sections. Only NCS C3PR Admins should have access to all roles.


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b. Select an organization from the list.

6. Select applicable research staff role(s) by checking the box next to the appropriate role

Examples of the recommended NCS research staff permissions are listed below and can also be

found in Appendix A, which outlines role descriptions.

a. NCS C3PR Admins: The C3PR Admin role is typically assigned to one or two “Super Users” who are responsible for IMS and overall data. These users will have either all access or the roles described below:

b. Data Collectors: Data Collector staff only need to review Study specific information associated with a NCS Subject or Participant located within C3PR. Data Collectors are not given any global roles and only have the Subject manager and Registration roles. See an example below:


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c. Data Quality: The Data Quality team is responsible for NCS Subject and/or Participant data entered and updated within C3PR. Data Quality team members have no global roles, and typically have Registration QA manger, Study QA Manager, Study Manager, and Registration roles. See an example below:

Note:

Each Study Center will determine the appropriate roles for their staff based on their quality plan.


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7. Click Create research staff icon at the bottom right corner of the computer screen when data

entry is complete.

Managing Research Staff

This function is used by administrators primarily to update information about research staff.

1. Click Persons & Organizations tab, followed by the Research Staff icon on the C3PR home

screen.

2. Click Manage Research Staff tab.

3. Enter search information for the research staff to be managed. The user may search by first

name, last name, NCS identifier, or organization, and then, click Search.


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Note:

Leaving the search fields blank will return a list of all research staff in all organizations.

4. Click the research staff member from the search results to bring up the Research Staff summary

page to display current information about that research staff member.

5. Click located in the bottom right hand corner of the page to save updates made to

research staff account information.


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Section 3 ‐ Report Generation The following section outlines report generation functionality of CRIS applications.

LimeSurvey

Generating Response Reports

To generate LimeSurvey Response Reports, the administrator must first export the survey data from

Limesurvey. The steps are listed below.

1. Select the survey to export data from using the Surveys dropdown list on the Administration

toolbar.

2. Hover the cursor over the Responses icon and click on Responses & Statistics on the Survey

toolbar to go to the Response summary page.

a. Below is an example of the Response summary, which displays the number of responses

saved, completed responses, and incomplete responses.


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3. Click Export a VV survey file icon to go to the Export a VV survey file page.

a. The Export survey number will populate automatically.

b. Choose Complete Responses Only, Incomplete Responses Only, or All responses

options in the Export dropdown box, or do nothing and the Export box will default to All

responses.

c. The file extension default is csv, but can be changed to xls, tab, or txt. This file can be

opened and modified in Microsoft Excel.

4. Click Export results to complete the export process.


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Note:

The Export survey number is the default name and cannot be modified.

C3PR

Generating Study Registration Reports

C3PR functionality outlined in this document was obtained in April, 2012 from the C3PR user guide

(ver 2.9.1) located on the National Cancer Institute Wiki:


C3PR allows for the generation of multiple reports, based on Participant, Subject, or Study. To get

started, log in to the CRIS portal and select the C3PR Module link from the CRIS landing page.

1. Click on the Reports tab from the C3PR home page, followed by the Search Registration icon.

2. Enter Search Criteria into any of the fields and then click Search Registration to locate a

specific report.


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Note: Leaving the Search Criteria fields blank will return a list of all registrations.

3. Sort the search results by entering the appropriate information into the text fields at the top of

each column, and then, click Filter.

4. Once the results are filtered, the screen will display the desired report.


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Section 4 ‐ C3PR Study Management C3PR functionality outlined in this document was obtained in April, 2012 from the C3PR user guide

(ver 2.9.1) located on the National Cancer Institute Wiki:


C3PR offers the functionality to create additional studies, or manage existing studies. To utilize this

functionality, access the Studies tab on the C3PR main page.

Creating a New Study

1. To add a study to C3PR Click the Studies tab in the navigation bar, followed by Create Study.

2. The Details page opens. The following information must be added to create a study in C3PR:

a. Details b. Consent c. Epochs & Arms d. Eligibility e. Stratification f. Randomization g. Diseases h. Companion Studies i. Overview

Note:

Randomization, Diseases, and Companion Studies are not discussed in this document because they are not currently part of the NCS protocol. However, they have been included in this section because C3PR displays these options during the study creation process.

Entering Details About the Study

The Details page enables the user to enter general information about the study.


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1. Enter details of the study. a. Short Title is the title for which the public will know the study as defined in the

protocol. b. Long Title is the official title as provided and entered by the principal investigator or

sponsor. c. Description Optional is a detailed description of the study, including information

not covered by other fields, such as comparison studies. d. Precis is a structured description of a protocol document. e. Select the Phase of the study. f. Target Accrual is the total number of studies needed for enrollment according to

the study protocol (accrual). g. The Type indicates the type of study. h. The Therapeutic Intent indicates whether the study/epoch involves treatment, and

Yes means that the subject accrual data will be included in the Summary 3 Report using the Generate Summary 3 Option.


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Note:

To perform Summary 3 reporting for this study, the study/epoch must specify that it has Therapeutic Intent. Therapeutic Intent in the C3PR context is used to explicitly flag a study for Summary 3 reporting.

i. Phase is the coded designation of the phase of the clinical trial: i.Phase 1 are initial studies to determine the metabolism and pharmacologic

actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.

ii.Phase II are controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication(s) in patients with the disease or condition under study; and to determine the common short‐term side effects and risks.

iii.Phase III are expanded, controlled, and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit‐risk relationship of the drug, and provide and adequate basis for physician labeling.

iv.Phase IV are post‐marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

v.Pilot vi.N/A

j. Blinded indicates whether the participants are not aware of what treatment they are receiving.

k. Version name/number of the protocol. Examples ‐ ‐ Original version or Amended version.

2. Specify whether the study is Stratified. If the study is stratified, the administrator will have to add stratification questions to the study to create stratum groups. These questions will ensure that population groups, such as ages and genders, are equally represented across treatments.

3. Specify whether the study is Randomized. If the study is randomized, the registrants will be randomly assigned to treatments through Book or Phone Call randomization.

a. A Book is a list of physicians who can register subjects to the study. From the randomly selected‐physicians, eligible, stratified subjects will be registered into the study. This option is available only when the study is Stratified and stratum groups are assigned.

b. The Phone Call is the phone number of the organization's Randomization Office. When a subject is registered, the Registrar will call the phone number.

4. A Coordinating Center is a group organized to coordinate the planning and operational aspects of a multi‐center clinical trial. Enter the first few letters of the name of the Coordinating Center and select it from the drop down list that appears. Note: This is an auto‐populated field. If the name is not in the drop down list that appears, contact the C3PR system administrator.

a. Study Identifier indicates a number representing the protocol assigned by the Coordinating Center.


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5. A Funding Sponsor is the entity sponsoring the study. Enter the first few letters of the name of the Funding sponsor and select it from the drop down list that appears. This is an auto‐populated field. If a name is not in the drop down list that appears, contact the C3PR system administrator.

a. Study Identifier indicates a number representing the protocol assigned by the Funding Sponsor.

6. Principal Investigator is one medical researcher in charge of carrying out the clinical trials’ protocol. Enter the organization and the name of the investigator. Enter a portion or a complete name of the PI and select the appropriate name.

a. If the principal investigator is not listed, click Create Principal Investigator to add an investigator to C3PR.

Note:

A principal investigator (PI) must be associated with an appropriate organization in order to create a

study.

7. To save changes, click Save. a. To save changes and return to the previous page, click Save & Back. b. To save changes and continue to the Therapies page, click Save & Continue.

Note:

If all of the information for the study cannot be entered at one time, complete the current section and

then click the Overview section tab. This action will save the study. To finish entering the information

into the study at a later time, search for the saved study.

Adding Consents to a Study

On the Consents page the user can add one or more consents that need to be signed for the current protocol. An example of multiple consents may include a general consent and a parental consent for a minor subject.

To add consents to the study:

1. Specify how many Mandatory consents there are associated with the current protocol. 2. One or All. 3. Click *+ Add Consent and enter the name of an additional consent.


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4. To save changes, click Save.

a. To save changes and return to the previous page, click Save & Back. b. To save changes and continue to the Agents page, click Save & Continue.

Note:




Adding Epochs and Arms to a Study

The Epochs & Arms page enables the administrator to create an enrolling epoch for subject registration and add arms to the epoch to describe the treatment approach. An epoch is a vertical segmentation within a study with one or more arms, which may or may not run in parallel with respect to time. Each treatment approach in a trial is referred to as an arm of the trial. The number of epochs and arms that can be added is unlimited.

Note:

To expand and collapse epochs and arms on the page, click the Plus or Minus in the upper left corner of

the epoch or arm box.

1. Click + Add Epoch to add an epoch to the study.


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a. Enter a Name or a coded value that represents the arm. b. Enter a number that represents the Order in which the subject will progress from epoch

to epoch. Epochs with the same order value occur parallel in time. c. Specify the Type of epoch, such as Screening, Treatment, Follow‐up, or Reserving.

Enrolling* enables the user to specify whether the subject is participating in the epoch and enrolled in the study. If the subject is not enrolled, the subject is registered to an epoch, but not participating in the study.

d. Enter a Description of the epoch. e. Specify the Accrual ceiling or the maximum number of subjects allowed to participant in

the epoch. f. If the study was selected for stratification, indicate whether the epoch will be Stratified.

At least one epoch must be stratified.

g. Click Save.

2. Click + Add Arm to add an arm to the epoch. a. Enter a name for the treatment arm or group. b. Enter a full Description of the group or treatment. c. Use the Accrual Ceiling to specify the number of subjects targeted for accrual to an arm

of a treatment epoch


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d. Click Save. 3. Continue to add arms to the epoch or new epochs to the study as needed. 4. To save changes, click Save.

a. To save changes and return to the previous page, click Save & Back. b. To save changes and continue to the Eligibility page, click Save & Continue.

Note:




Determining Eligibility for a Study

The Eligibility page enables the user to add inclusion and exclusion questions to determine subject eligibility. Alternatively, the administrator can import a caDSR file that contains the questions. An eligibility checklist is a set of inclusion and exclusion questions that determine whether a patient is eligible to participate in the protocol. A C3PR user, such as a registered nurse, answers the checklist questions based on patient responses, and then attempts to register the patient for the protocol. All inclusion questions must be answered Yes and all exclusion questions answered No.

To import eligibility criteria for a study:

1. A caDSR file contains inclusion and exclusion criteria. To import a caDSR file, go to the NCI Form Builder web site.

2. Click Browse, select the file, and click Upload.

To manually enter add inclusion and exclusion criterion:


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1. Enter Inclusion Criterion: a. Specify a question, that when answered with a Yes, will make a subject eligible for

participation in a study. The question must be on the eligibility checklist of the protocol. b. Specify whether the subject has the option to select N/A as an answer to an inclusion

criterion. c. Add more inclusion questions. The number of inclusion questions is unlimited.

i. To delete a criterion, click the x to the right of the criterion. d. Click Save.

2. Enter Exclusion Criterion:

a. Enter an individual question, that when answered with a No, will make a subject eligible

for participation in a study. The question must be on the eligibility checklist of the protocol.

b. Specify whether the subject has the option to select N/A as an answer to an exclusion criterion.

c. Add more exclusion questions. The number of exclusion questions is unlimited. i. To delete a criterion, click the x to the right of the criterion.

3. Click Save. a. To save changes and return to the previous page, click Save & Back. b. To save changes and continue to the Disease page, click Save & Continue.


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Note:

If all of the information for the study cannot be entered in one sitting, complete the

current section and then click the Overview section tab. This action will save the study.

To finish entering the information into the study at a later time, search for the saved

study.

Adding Questions for Stratification Factors

On the Stratification page the user can add questions, answers to the questions, and then based on the questions and answers, create stratum groups. When a subject is registering, the subject must answer the stratification questions, and based on the answers, the subject will be placed in a certain stratum group based on the study's protocol. Stratification of the participants ensures that populations of, for example, a certain age or gender, will be evenly distributed across treatments.

Note:

At least one epoch in a stratified study must be specified as stratified to define stratification factors.

To specify questions to determine stratification factors:

The above image shows the section of the Stratification page. This is where study stratification factors are entered. There is a question box along with two boxes for the answer. Beneath these two boxes, there is a blue +Add Answer button. Beneath this box, to the left are two more blue buttons: one to add stratification criterion, and one to generate


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Note:




stratum groups.

1. To add a stratification factor question to a stratified epoch, click + Add Stratification Criterion.

a. Enter a Question. b. There are boxes for two answers. Enter the answers. c. To add additional answers, click Add Answer and enter more answers. d. To delete an answer, click the x to the right of the answer. e. To delete a question, click the x to the right of the question. f. To add another question, click + Add Stratification Criterion. g. To collapse a question, click the minus sign (‐) on the left side of the question box.

Click the plus sign (+) to expand the question and display the information. 2. Click Save. 3. To create stratum groups for the epoch, click Generate Stratum Groups.

a. Every combination of answer creates its own group. b. To adjust the level of the group, click and drag the group to a lower/higher level. c. To delete a stratum group from the list, click the x to the right of the group row.

4. Click Save. a. To save changes and return to the previous page, click Save & Back. b. To save changes and continue to the Randomization page, click Save & Continue.

Reviewing the Study Overview

The Overview page summarizes all the information entered about the study.

1. Each step followed to define the study has a corresponding heading on the Summary page such as Diseases and Companion Studies.

a. If the section name has a pencil icon next to it, click the section name to open the page to edit. Make the changes, save the changes, and click Save. Click Summary to


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return to the Summary page. b. If the information is in red, it is not complete. Click the section name to open the

page to edit. Make the changes, save the changes, and click Save. Click Overview to return to the Overview page.

2. Once the study is complete, on the Overview page, additional tasks can be performed with the study.

Note: Randomization, Diseases, and Companion Studies are not discussed in this document because they are not currently part for the NCS protocol. However, they have been included in this section since C3PR displays these options during the study creation process.

Managing an Existing Study

Once a study is added to C3PR, additional tasks can be performed with an existing study using the Managing Studies option.

Editing an Existing Study

1. Click on the Studies tab from the C3PR home page, followed by Manage Study:

2. To search for a study, first select an Identifier, Study Title or Status as the search type. Next,

enter text in the Search criteria field (e.g. study status) and then click Search. Leave the Search

criteria field blank to get a list of all studies in the local database. However, searching based on

status is not supported when using NCI Enterprise Services (COPPA). The NCI Enterprise

Services is a repository of clinical trial protocol abstraction, persons, organizations, and the

associations between them. If the instance of C3PR is configured properly, the administrator

can search for a study within NCI Enterprise Services, and update the information on NES from

C3PR. You may experience some delays if NCI Enterprise Services (COPPA) mode is enabled.


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Note: C3PR was built on the caBig platform and utilized primarily by the National Cancer Institute (NCI). The National Children’s Study does not utilize the NCI Enterprise Services (COPPA) repository. However, this wording is still included within the C3PR software. In order to avoid confusion on the user’s part, it was determined that this information would be included within this document.

3. Search results can be sorted by entering the appropriate information into the text fields at the

top of each column and then clicking Filter.

4. Select the Study to be modified. This action will display the Study Summary page.

5. On the Summary page, review the study values.

a. If information on the Summary page is red, it is not complete. Click on the section name to open the page, update the information, save the changes, and return to the Summary page.

b. If a section name has a pencil icon next to it, click the section name to open that page, update the information, save the changes, and return to the Summary page.

6. Once the study is complete, tasks can be performed from the Summary page using the numbered task bar or icon bar.


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Managing Studies from the Summary Page Task Bar

After selecting the study, the Summary page will be displayed. To review additional information about

the Study and/or make changes to the Study, the user may choose the numbered task bar at the top of

the Summary. The Summary page is varied based on the user role in C3PR.

Note: Steps 2 (Sites) and 3 (Identifiers) are not discussed in this document due to the fact that once created by the CRIS Team, they will not be modified for the NCS, at least at this time. However, the wording is still located within the C3PR software.

Reviewing Study Summary

Review all of the details on the Summary page, including basic information, principal investigators, identifiers, consents, epochs & arms, eligibility criteria, diseases, and companion studies. This summary can also export in XML format; to do so, click on the Export XML button in the upper right‐hand toolbar.


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Adding Investigators to a Study

To associate an investigator with a study, select from a list of organizations associated with the study. The investigators are listed. The administrator may add all, an investigator group (if defined as such), or an individual investigator to the study.

To associate an investigator with a study:

1. From the study Summary page, click the Investigators task.

2. Click the Organization list and select an organization associated with the study.


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3. Select an investigator group to add. 4. Select All or an individual investigator to add to the study. 5. Click Add and the name(s) will appear in the Site panel on the right side of the page. The status of

the investigator is Active. It can be changed to Inactive as needed.

6. If an investigator is not listed, click Create Investigator to add an investigator to C3PR.


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7. Once all of the investigators are entered, click the Save button at the bottom right hand corner of

the page.

Adding Personnel (Research Staff) to a Study

To associate personnel with a study, select from a list of organizations associated with the study. The personnel are listed. Add all or an individual personnel member to the study.

To associate personnel with a study:

1. From the study Summary page, click the Personnel task.

2. Click the Organization list and select an organization associated with the study.

3. Select All or an individual personnel member to add to the study.

4. Click Add and the name(s) will appear in the Site panel on the right side of the page. The status of

the personnel member is Active. It can be changed to Inactive as needed.

5. If an individual personnel member is not listed, click Create Research Staff to add a new research staff (user) to C3PR.


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6. Once all of the personnel information is entered, click the Save button.

Adding Notifications to a Study

The Notifications page enables the user to send a notification or email when a specified accrual is reached. Notifications can be sent to one or more email address and one or more roles associated with the current study. If a user is sent a notification, it appears in the user's Mail Inbox on the C3PR Dashboard. To return to the dashboard, click the C3PR logo on the upper‐left corner.

To add a notification to a study:


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1. From the study Summary page, click the Notifications task. 2. Click + Add Notification.

a. Specify the target accrual for notifications will be sent. b. Enter the email address to send the notification. Click the plus sign (+) to add

more email addresses. c. Select the role to which the notification will be sent. Click the plus sign (+) to

add more roles. d. To remove an email address or role, click the x next to the row. e. To delete a notification, click the x in the upper-right corner of the notification. f. The administrator can add more than one notification to specify when different target

accruals are fulfilled. 3. Once all of the notifications are added, click Save.

Registering Additional Subjects to the Study

The Registrations page enables the user to review registrants for a study or register additional subjects to a study.

To add a registrant to a study:

1. From the study Summary page, click the Registrations task.

2. The user can review currently registered subjects, or add new notifications. 3. Once all of the registrations are added, click Save & Continue.


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Reviewing Amendments to the Study

On the Amendments page, the user is able to review any amendments that have been made to the existing study.

1. From the Summary page, click the Amendments task. If there are no amendments, the page will

be empty. If there are amendments, a table lists the amendments.

2. For each applied amendment, there is the version/name number, the date the amendment was applied, and the status of Active. To view the amendment changes, click View. The Amendment Details page opens. Click Close to return to the Amendments page.


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3. For an amendment that has not been applied yet, the status is Inactive.

a. To continue to modify the study, click Resume Amendment and make changes to the study. b. To apply the amendment to the study, click Apply Amendment. Once a confirm has been

complete, the Amendments page will display the amendment status as Active.

c. To view a summary of the amendment, click Summary. Close the window to return to the

Amendments page.

Managing Studies from the Summary Page Icon Bar

The Studies, Manage Studies tab enables the user to search for and select an existing study. Once the study is selected, the Summary page opens. Changes to the study may be made through the icon bar on the middle right of the Summary page. Functionality is varied based on the user role in C3PR.


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Closing a Study

To close a study:

1. On the Summary page, click Close Study.

2. The Close Study window opens.

3. Specify the reason for why the study is to be closed. a. Closed To Accrual and Treatment. The study is not accepting new registrants and not

performing treatment. b. Closed to Accrual. The study is not accepting new registrants. c. Temporarily Closed to Accrual. The study is not accepting new registrants, but this is

temporary. d. Temporarily Closed to Accrual and Treatment. The study is not accepting new


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registrants and is not performing treatment, but this is temporary. 4. Click Cancel to return to the Summary page without closing the study.

a. Click Close to close the study. The study now displays the status that was selected; to close or temporarily close the study.

Editing a Study

To review and edit a study:

1. On the Summary page, click the Edit Study icon.

2. Click Details to enter Study Details.

a. Click Consent to add to, modify, or delete existing consents.


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b. Click Epochs and Arms to add to, modify, or delete existing Epochs/Arms.


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Note:

Randomization, Diseases, and Companion Studies are not discussed in this document because they are

not currently part for the NCS protocol. However, they have been included in this section since C3PR

displays these options during the study creation process.

c. Click Eligibility to add or remove Inclusion and Exclusion Criteria:

d. Click Stratification to add Stratification (Currently not in use for NCS). e. Click Randomization to add Randomization (Currently not in use for NCS). f. Click Diseases to add Diseases (Currently not in use for NCS). g. Click Companion Studies to add Companion Studies (Currently not in use for NCS). h. Click Summary to review an updated Summary page of the Study.


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Amending a Study

To amend a study:

1. On the Summary page, click Amend Study.

2. A message appears. Are you sure you want to amend the study?


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a. Click Cancel to return to the Summary page or Amend Study to continue. The Amendment Details page opens.

3. Enter the Version name/number, which is the latest version name or number of the study. 4. Enter the Amendment type, which is divided into three categories:

a. Immediate where this amendment has to be applied immediately. b. Immediate with grace period, where amendment can be applied after certain number

of days. c. Optional, where these amendments are optional.

5. Grace period (days) is applicable for "Immediate with grace period" amendments only. This is the time frame when a user has to apply a new amendment.

6. Amendment date is the date when the amendment was created.

NOTE:

This date cannot be in the future and has to be later than the previous study version date.

7. Enter any additional Comments for this amendment. 8. Check off the Reasons for the Amendment. One is required.

a. Basic detail


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b. Epoch & Arms c. Eligibility d. Stratification e. Randomization f. Diseases g. Consent

9. Click Save or Save & Continue to edit the Study.

Editing a Study Target Accrual

When a study is created, the administrator can edit the study's Target Accrual on the Summary page or by searching and selecting a study and then opening the Summary page. The target accrual is the number of subjects to be registered to the study.

To update a target accrual for a study:

1. On the Summary page, click Edit Accrual.

2. The Update Accrual window opens. The window shows the current target accrual. Update the Target Accrual as needed and click Save.

3. If the target accrual is updated, the following message will be displayed: Target accrual has been updated.

Exporting a Study to an XML File

To export a study to an XML file:

1. On the Summary page, click the Export XML icon.


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2. The following message will be displayed: Do you want to Open or Save this File? a. Click Open to display the XML file in a window. The user can Save As, Print, or perform

any of the options accessible from the menus. b. Click Save, then enter a file name and save the file.

Printing a Study

To print a study:

1. On the Summary page, click the Print icon.

2. A window opens with a C3PR preview of the study. The print dialog box opens. 3. Click Print to print the study information.


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Appendix A C3PR Roles and Descriptions

Role Scoping Description

Adverse Event (AE) Study Data Reviewer

Site & Study

Read‐only: Reviews, provides comments, and adverse event data through a review workflow

AE Expedited Report Reviewer Site & Study

Read‐only: Reviews, provides comments, and routes expedited reports through the review workflow

AE Reporter Site & Study

Creates and updates information about an AE that needs to be reported, and submits report to appropriate parties per the report definition. Enters set of required AEs that have to be assessed and any additional AEs that the participant experienced.

AE Rule and Report Manager Global Creates, manages, imports AE rules. Creates, manages, imports AE report definitions.

Business Administrator Global

Manages the domain related application wide properties and behavior (i.e. label names, reference data lists, etc).

Data Analyst Site & Study

Read only ‐ searches for data, uses built‐in analysis tools, exports data to third party tools.

Data Importer Global

Identifies studies defined by Coordinating Center and imports as a consumer that data defined elsewhere.

Data Reader Site & Study

Read only role: Typically not part of the org that they are auditing, but granted temporary read‐only access to a particular study (no modifications allowed), access might be to whole study or specific subjects on the study, any data entered by the site for that subject on that study, crosses all apps (i.e. registration‐, AE‐ and possibly calendar‐related data).

Lab Data User Site & Study

Enters, edits, and imports labs from LIMS, viewing labs, selecting and sending labs to CDMS and caAERS.

Lab Impact Calendar Notifier Site & Study

Ceates a calendar notification for a potential lab‐based treatment modification.

Person and Organization Information Manager Site

Manages organizations and rosters. Creates and updates person info including contact info, degrees/certifications, rosters they are associated with.


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Registrar Site & Study

Accepts and approves/denies subject registration requests; requests subject registration on a particular study.

Registration QA Manager Site

Updates registration information (study subject ID, Date of consent) after enrollment. Can waive the eligibility criteria for certain study subjects.

Study Calendar Template Builder Site & Study Creates and updates study calendar templates.

Study Creator Site

Creates the core study info (e.g. PI, title, description, phase, epochs/arms & basic study design, etc.) NOTE: some sites may want to combine the supplemental study info roles into this role.

Study QA Manager Site

Updates the core study info (e.g. PI, title, description, phase, epochs/arms & basic study design, etc.) after saving and opening the study. Does read‐only review of study calendar template data and releases templates for use at participating sites. Does read‐only review of released study calendar templates, indicating when they have been approved for use at a participating site. Performs read‐only review of study calendar template data and releases templates for use at participating sites. Performs read‐only review of released study calendar templates, indicating when they have been approved for use at a participating site.

Study Site Participation Administrator Site Connects participating sites to a protocol.

Study Subject Calendar Manager Site & Study

Creates and updates a subject‐specific study calendar based on a study calendar template.

Study Team Administrator Site

Connects study level people to the study and internal staff to the study; assigns internal staff to a protocol; determines which study artifacts (e.g. study calendar templates, CRFs, etc.) are accessible by each particular staff member.

Subject Manager Site Defines patient to system (remaining subject data managed by other roles which are not defined).

Supplemental Study Information Manager Site

Adds treatment assignment codes, drugs, adEERS‐specific diseases?, whether study requires adEERs reporting, CTC/MedDRA version to use, etc. Update and manage registration metadata (e.g. stratifications, eligibility criteria, notifications, target accrual, multi‐institutional indicator, consent form version, study randomized indicator, etc.).


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System Administrator Global

Configures the technical system level properties and behavior of the applications (i.e. the password policy, email setup, ESB, etc).

User Administrator Site

Ability to read system personnel (research staff and investigators) and create/manage user accounts/application roles, defines Custom Combination roles.

module 5 cris administrative...cris manual of operation april 2012 3 section 1‐ overview this...

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