Oracle® Health Sciences Site AnalyzeCloud ServiceUsing Oracle Site Analyze: For Oracle SiteActivate Users

Release 19.1F20403-01July 2019

Oracle Health Sciences Site Analyze Cloud Service Using Oracle Site Analyze: For Oracle Site ActivateUsers, Release 19.1

F20403-01

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Contents

1 About the Data Dictionary, Access, and User Roles

2 About Viewing Reports and Using Tableau

3 Account Metrics

4 Cycle Times

5 Adoption and Compliance

6 All Activities + Notes

7 Contract Module Status

8 Delivery Dashboard

9 Milestone and Submission Planning

10

Open Activities

11

Quarterly Business Review

iii

12

Regulatory Submissions and Approval Status

13

Resource Allocation

14

Site IP Release Package

15

Site Reconciliation

16

Study Startup Industry Benchmarking

17

Study Summary

18

Workbook Permissions and User Groups

iv

Documentation Accessibility

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5

1About the Data Dictionary, Access, andUser Roles

Oracle Site Analyze is the reporting and visualization application that supplements re‐ports available in the Oracle Site Activate clinical study startup application. Below, weprovide an introduction to the data dictionary, instructions for accessing Oracle SiteAnalyze, and more.

Getting started with Oracle Site Analyze

Oracle Site Analyze reports allow you to view status and other data about the activitiesthat your study team performs in Oracle Site Activate. With Oracle Site Analyze, youcan customize reports and share them with external partners.

All report data comes from Oracle Site Activate where information about sites, docu‐ments, submissions, milestones, and the status of activities related to them aretracked and managed.

In Oracle Site Analyze you can view:

• Standard reports created by Oracle

• Custom reports prepared by your study team members (who have admin privileg‐es)

A data dictionary that reflects your work

The Oracle Site Analyze data dictionary is built to provide insight on common studystartup tasks. For example, study milestone data can be used to build a report show‐ing planned versus expected study milestones, while cycle time data items give youthe ability to identify bottlenecks or improve processes.

Whatever your reporting needs, one or multiple items in the Oracle Site Analyze datadictionary can meet them.

Accessing Oracle Site Analyze

If you have the appropriate permissions to access Oracle Site Analyze reports, you'llnavigate to Oracle Site Analyze (Tableau) from within the Oracle Site Activate applica‐tion. In the Oracle Site Activate top navigation bar, click Reports, then click Analyzereports.

Note:

Oracle Site Analyze reports are not backward compatible to previous OracleSite Activate releases. Customers who want access to the enhanced reportsin 19.1 Oracle Site Analyze must upgrade their Oracle Site Activate releaseto 19.1 as well. Please contact your Oracle Project Manager or AccountManager for more information about upgrading.

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Roles control access to information

Oracle Site Analyze controls who has access to certain data views. There are tworoles:

1. business intelligence (BI): This super user role can view all reports, and createor edit reports.

2. view only: Users with this role can view a subset of the standard Oracle Site Ana‐lyze reports and reports that BI users share with them.

Chapter 1

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2About Viewing Reports and Using Tableau

Below we describe the Oracle Site Analyze project dashboard and workbooks and de‐scribe how users can export and share report data.

Project dashboard and workbooks

When you log into Oracle Site Analyze, you’ll see a list of projects - each of theseprojects include workbooks that contain standard reports or any custom reports thatwere prepared by a member of your study team.

Please note: For the following reports, Oracle Site Analyze users will view only thosestudies that they have permission to view in Oracle Site Activate:

• Study Summary Dashboard

• Documents and Submissions

• Regulatory Submissions and Approval Status

• All Activities + Notes

• Open Activities

• Milestone and Scheduled Activity Planning

• Delivery Dashboard

• Contract Module Stats

• Site IP Release Package Dashboard

With any Oracle Site Analyze report, you can sort and filter the data. You can restoreany changes you make to the original format or save them permanently. You can alsoturn off automatic updates, so the data you see remains consistent during your editingexperience. Subscribe to reports and receive email updates daily or weekly when thereport data changes.

On the Workbooks page, you can select the checkbox next to a report to access addi‐tional features.

• Edit: allows you to edit the report, if you have appropriate permissions

• Download: saves the report (you can use the Tableau desktop application to opendownloaded reports)

• Tag: you can associate the report with a category you define; this way, you caneasily find the report by filtering by the category name

• Permissions: allows you to determine who can view, interact with, and edit re‐ports (if you have been granted permission to control permissions)

• Move: use this to move the report to another folder or project in the workbook

• Change owner: not enabled for view only users

• Extract refresh: not enabled for view only users

• Tabbed views: allows you to view all reports in the workbook as tabs

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• Delete: allows you to delete the workbook, if you have appropriate permissions

Export formats

You can export your report data in the following formats:

• spreadsheet (single or multiple tab)

• Adobe Acrobat (PDF) format

• image (PNG) format

Note:

We recommend that you use either spreadsheet or PDF format. If your reportcontains charts, graphs, or other images, those are not included when youexport in spreadsheet format. Additionally, when you export a dashboard,you see only what appears on your screen; to export all pages in a report,always export the entire report.

Sharing web views

You can share Oracle Site Analyze reports with others on your study team or externalpartners. When you share, recipients receive an email that contains a link to view thereport.

Note:

Anyone with whom you share a report must have Oracle Site Analyze ac‐cess. However, you can export an Oracle Site Analyze report and send it tothose without access.

Procedures

The links below redirect to Tableau v10.5 online documentation.

• Explore and analyze data in a view

• View and sort content

• Save your work

• Refresh data or pause automatic updates

• Subscribe yourself or others to a view

• Unsubscribe yourself from a view

• Export data

• Use Custom Views

• Export views

• Share web views

Chapter 2

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3Account Metrics

Workbook Synopsis

This workbook provides a dashboard view of studies, sites, and users in Oracle SiteActivate, as well as detailed cross-tab sheets of each.

Dashboards and Sheets

Studies Dashboard

The Studies Dashboard shows:

• Number of studies added to Oracle Site Activate over time

• Breakdown of studies by different criteria

• Running count of studies over time

Notes:

• You can view the study detail on the "Studies Detail" worksheet of this workbook.This worksheet provides filters (e.g., Study Name, Therapeutic Area, Phase, etc.)you can use to subset the data in the detail worksheet.

• If there were no studies created for a particular period, you will not see data forthat period in the dashboard.

• You can view studies broken down by different attributes captured in Oracle SiteActivate, such as Region, Country, Therapeutic Area, etc., as well as by customflex string values.

• The caption at the bottom of the dashboard shows when the data was last updated(Data as of…).

Dashboard

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Detail

Sites Dashboard

The Sites Dashboard shows:

• Total number of sites in Oracle Site Activate

• Sites added last month

• Sites added this month

• Sites added this week

• Running total of sites added over time

Notes:

• You can view the site detail on the "Sites Detail" worksheet of this workbook. Thisworksheet provides filters (e.g., Study Name, Site Number, etc.) you can use tosubset the data in the detail worksheet.

• If there were no sites created for a particular period, you will not see data for thatperiod in the dashboard.

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• The caption at the bottom of the dashboard shows when the data was last updated(Data as of…).

Dashboard

Detail

Activate Users Dashboard

This dashboard shows:

• Total number of users (excluding Oracle users)

• Total number of users added last month (excluding Oracle users)

• Total number of users added this month (excluding Oracle users)

• Running total of users added over time

Notes:

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• You can view the user detail on the "Activate Users Detail" worksheet of this work‐book. The worksheet provides several filters (e.g., User Name, Business Role,Sign in Count, etc.) that allow you to subset the data included in the detail work‐sheet.

• If there were no users created for a particular period, you will not see data for thatperiod in the dashboard.

• The caption at the bottom of the dashboard shows when the data was last updated(Data as of…).

Dashboard

Detail

Chapter 3

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4Cycle Times

Workbook Synopsis

This Cycle Times dashboard, which is intended for Oracle Site Activate customers, in‐cludes six key cycle metrics with configurable cycle start and end points. Users cansave their own custom views with the cycles that provide the most value to them.

Each whisker-plot cycle has a corresponding "Cycle Detail" page with additional analy‐sis such as difference from the mean, performance over time, distribution and the abili‐ty to export a crosstab with site details.

Dashboards and Sheets

Key Cycle Times

This dashboard shows cycle times displayed in a box-and-whisker plot to show me‐dian and distribution of cycle times.

Clicking the arrow will send you to the specified cycle times detail dashboard. The"Slice Data By" filter on the right enables you to analyze via box-and-whisker-plot bydifferent attributes (Study, Country, therapeutic area, etc.).

Additional filtering options on the right limit what data is being compared (e.g., slice da‐ta by study but filter to only compare studies in a particular therapeutic area).

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Cycle Details

This dashboard shows:

• Cycle delta from mean: plots cycles by data slice in relation to the mean cycletime.

• Cycle performance over time: compare current vs previous week, month, quarteror year

• Cycle standard distribution: analyze how data is distributed

• Cycle time detail: crosstab with details including site information, if applicable

• Crosstab export: export all data in CSV format

The "Slice Data By" filter to the right enables you to analyze via box-and-whisker-plotby different attributes (study, country, therapeutic area, etc.). Additional filtering op‐tions to the right limit what data is being compared (e.g., slice data by study but filter toonly compare studies in a particular therapeutic area).

This view also allows you to export data in CSV (comma separated value) format.

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5Adoption and Compliance

Workbook Synopsis

The Adoption and Compliance Dashboard provides high-level insights across a broadrange of metrics for Oracle Site Activate ramp up, usage, planning, activity, and com‐pliance. With a layout designed for quick review and ideal for email subscriptions, it in‐cludes access to the underlying tabular data that drives the dashboard visualizationswhen deeper analysis is required.

Dashboard and Sheets

Adoption and Compliance Dashboard

The Adoption and Compliance Dashboard includes five sections: ramp up, user logs,milestones, activities, and compliance. Users can click in to data points displayed onthis dashboard for additional details and available filters.

ramp-up section

• studies added over time

• sites added over time

• users added over time

• % of users that have been assigned to a least one study

user logs section

• % of total users that log in over time

• last user login by month, large number: users that haven’t logged in for 90 days

• average logins per user over time

• sites with site experience users that have had 0 logins

milestones section

• % of total milestones that have been planned

• milestones due this time period and overdue milestones

• over milestones completed, how many were planned

• % of milestones completed on time

activities section

• total activities completed over time

• average activities completed by user each month

• % of site activities completed by site experience users (configurable for site activityspecific roles)

• median time from activity alert sent to activity being completed

compliance

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• sites out of IP release status compliance over time

• sites out of role compliance over time

• sites out of activation compliance over time

• sites out of activity compliance over time

Studies Detail

This worksheet includes ramp-up study details like created date, country, country cre‐ated date, sites planned, and more. Use Study, Study Status, Country, and/or Daterange filters to adjust the view.

Sites Detail

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This worksheet includes ramp-up site details like study, country, number, status, andmore. Use Site Status, Study, Site Number, Site Network, and/or Created Date filtersto adjust the view.

IP Release Compliance Detail

This worksheet includes IP release milestone compliance details, by site. Use SiteStatus, Study, Site Number, IP Rel Milestone Completed Date, and/or Created Date fil‐ters to adjust the view.

Role Compliance Detail

This worksheet includes role compliance details, by site. Use Site Status, Study, SiteNumber, and/or Created Date filters to adjust the view.

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Activation Compliance Detail

This worksheet includes activation compliance details, by site. Use Site Status, Study,Site Number, Created Date, and/or Minimum Days in Activation filters to adjust theview.

Activity Compliance Detail

This worksheet includes activity compliance details, by site. Use Site Status, Study,Site Number, Created Date, and/or Minimum Days Since Last Activity filters to adjustthe view.

Users Detail

This worksheet includes ramp-up details, by user, including total number of users add‐ed over time. Use the User Name and/or Created Date filters to adjust the view.

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User Assignment Detail

This worksheet includes study assignment details, by user. Use User Name, Role,Study, Site Number, Created Date, and Assigned (yes/no) filters to adjust the view.

User Logs Detail

This worksheet includes login details, by user. Use User Type (internal or site experi‐ence), User Name, and/or Total Logins Per User filters to adjust the view.

Dormant Accounts Detail

This worksheet includes days since last login details, by user. Use Days Since LastSign In, User Name, and User Type (internal or site experience) filters to adjust theview.

Chapter 5

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Sites With No Logins Detail

This worksheet includes details of sites that have site experience users assigned, butno logins from those site experience users. Use Study, Site Number, Role, and/orUser Name filters to adjust the view.

All Milestone Detail

This worksheet includes details for all milestones within a study. Use Study, ClinicalLevel, Site Number, and/or Milestone Delivery filters to adjust the view.

Milestones Due Detail

This worksheet includes details for upcoming, overdue, and planned milestones. UseDate, Study, Clinical Level, Site Number, and/or Milestone Status filters to adjust theview.

Planned Milestones Detail

This worksheet details for planned milestones including name, protocol version, dates,and milestone delivery (early, on-time, overdue, unplanned, etc.). Use Date, Study,Clinical Level, Site Number, and/or Milestone Delivery filters to adjust the view.

Chapter 5

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Completed Milestones Detail

This worksheet includes details for completed milestones. Use Study, Clinical Level,Site Number, Milestone Delivery, and date (baseline, planned, completed) filters to ad‐just the view.

Activities Detail

This worksheet includes activity details like artifact name, activity name (e.g., docu‐ment received/reviewed, complete document upload, etc.), completed date, activitycompleted by (user), and more. Use Study, Study Status, Site Status, Site Number,Activity Role, Activity Completed By (user), and Completed Date filters to adjust theview.

Site Activities Detail

This worksheet includes activity details, by site experience users.

Chapter 5

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Chapter 5

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6All Activities + Notes

Workbook Synopsis

Intended for Oracle Site Activate customers, this workbook lists the completed datesfor artifact activities for all studies in Oracle Site Activate on one worksheet. The sec‐ond worksheet lists the notes entered for artifact activities within Oracle Site Activate.Two export worksheets can be used to download the activities and notes data.

Worksheets

All Activities

This worksheet lists the activities for all artifacts for a study within Oracle Site Activate.Each record shows the business role and Oracle Site Activate user assigned to thetask, as well as the date the activity was completed.

There are multiple filters on the right-hand side of the worksheet that can be used tofind specific tracking items based on study name or status, portfolio, date range, clini‐cal level (country, site or study), and many others.

If an activity has been completed, the user name listed is the name of the user thatcompleted the activity. If the activity is still outstanding, the name listed is the primaryuser for the assigned business role.

All Notes

This worksheet lists all notes entered for a particular artifact activity, which Oracle SiteActivate user entered the note, and when it was entered.

There are multiple filters on the right-hand side of the worksheet that can be used tofind specific tracking items based on study name and status, date range, portfolio, sitename, user, and more. You can also filter the worksheet by Note Type (All, Activity,Artifact, General Country, and/or General Site).

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For general artifact notes, users can filter by “Show Artifact Note History” filter withyes/no options. When users select “yes,” the report includes only the most recent noteupdate for a general artifact note. When users select “no,” the report includes the en‐tire audit trail of all changes to a general artifact note.

Export All Activities

This worksheet, which is intended for export, provides detailed activity information.The worksheet provides multiple filters that allow users to adjust content prior to down‐load.

Export All Notes

This worksheet, which is intended for export, provides detailed notes information. Theworksheet provides multiple filters that allow users to adjust content prior to download.

Chapter 6

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Chapter 6

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7Contract Module Status

Workbook Synopsis

Intended for Oracle Site Activate customers, the Contract Module Status Dashboardcomplements the Oracle Site Activate contract module. Users can break down con‐tract status by assigned user, study, country, and region to provide visibility into con‐tract status and activity.

Managers can use the dashboard to view contract analyst workload. Users can accessadditional activity data through the dashboard and filter it based on selection.

Dashboards and Sheets

Contract Module Dashboard

This dashboard includes contract status overall, broken out by assigned user, region,country or study and crosstab of total contracts in each status

Contract Module Activity

This worksheet includes all activity that has been completed on selected contracts.Columns specify:

• Assigned

• Study Name

• Country

• Site Info

• Contract Group

• Contract

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• Avg. % Complete

• Contract Status (In preparation, In negotiation, Out for signatures, Partially execut‐ed, Fully executed, or Completed)

• Contract Info (metadata like Contracting Party, Payer, Bilingual, Site has MSA,etc.) that can be captured in Oracle Site Activate if these fields are enabled for theaccount.

The activity log includes date of activity, activity type and how long ago the activity oc‐curred. For open contracts, the calculation is today minus activity date. For completedcontracts the calculation is contract fully executed date minus activity date.

Site Budget Details Dashboard

The Contract site budget dashboard worksheet provides detailed budget informationacross an entire study. The dashboard allows users to evaluate budgets per site andtotal number of patients that are expected to enroll and includes:

Key performance Indicators

• average per subject cost

• average per subject cost deviation

• sum allocated number of patients

• average total one time up front fees

• average institutional overhead

Site budget metadata (if enabled for the Oracle Site Activate account)

• site name

• country

• per subject cost

• per subject cost deviation

• allocated number of patients

• total one time up front fees

• institutional overhead

• currency

• total one time up front fee breakdown

Chapter 7

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Chapter 7

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8Delivery Dashboard

Dashboard Synopsis

The Delivery dashboard, which is intended for Oracle Site Activate customers, is bro‐ken into two dashboards: Work Remaining and Work Completed.

Work Remaining: What work remains to be done, both upcoming and overdue. Gaininsight into "unblocked" items (what can be completed in Oracle Site Activate now andwhat items have been re-planned).

Work Completed: What work has been completed to date and planning accuracy(early, on-time, late, or completed without being planned). Crosstab export of raw datais also supported.

Dashboards and Sheets

Work Remaining

This dashboard shows:

• Milestones to be completed over time: cell color will be darker where more mile‐stones are planned to be completed. Cell which contain a red ‘X’ are milestonesthat are overdue.

• Delivery performance: tree map compares milestones that are:

– Overdue – Blocked: milestones that are incomplete after planned date that re‐quires more activities to be completed before the activity associated with themilestone can be completed.

– Overdue – Unblocked: milestones that are incomplete after planned date withan activity that is unblocked that will complete the milestone.

– Upcoming: milestones that are due in the future that have activities that needto be completed before activity tied to milestone can be completed.

– Upcoming – Unblocked: milestones that are due in the future with an activitythat is unblocked that will complete the milestone.

• Milestone planning accuracy: tree map compares milestones that are:

– Re-planned Out: milestones have been re-planned later than the baseline

– Re-planned In: milestones have been re-planned earlier than the baseline

– Not Re-planned: milestones have not been adjusted from the baseline

– Re-planned N/C: milestones have been re-planned with no change to thebaseline

The "Data Slice" filter, to the right, enables you to analyze milestones by different at‐tributes.

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Work Completed

This dashboard shows:

• Milestones to be completed over time: cell color will be darker where more mile‐stones were completed.

• Delivery performance: tree map compares milestones that are:

– Early: milestones completed 5+ days (configurable) earlier than planned

– Late: milestones completed 5+ days (configurable) later than planned

– On-time: milestones completed within 5 days (configurable) of planned

– Not planned: milestones completed but not planned.

• Milestone planning accuracy: tree map compares milestones that are:

– Re-planned Out: milestones have been re-planned later than the baseline

– Re-planned In: milestones have been re-planned earlier than the baseline

– Not Re-planned: milestones have not been adjusted from the baseline

– Re-planned N/C: milestones have been re-planned with no change to thebaseline

The "Data Slice" filter, to the right, enables you to analyze milestones by different at‐tributes.

Chapter 8

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Chapter 8

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9Milestone and Submission Planning

Workbook Synopsis

Intended for Oracle Site Activate customers, this workbook lists all the baseline, plan‐ned, and completed dates for all milestones and submissions within Oracle Site Acti‐vate.

Dashboards and Sheets

Milestone and Submission Planning

This worksheet lists the baseline, planned, and completed dates for all milestones andsubmissions and can be used to monitor compliance by highlighting any milestonesand submissions that are not planned or completed. Use the filters to the right to ad‐just data included in the report by Study Name, Country, Site Info, Event Name, EventLevel, etc.

Export Milestone and Submission Planning

Use the Export Milestone and Submission Planning sheet to export detailed planninginformation. You can filter data included in the export by Study Status, Portfolio, Coun‐try, Submission Type, and more.

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Chapter 9

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10Open Activities

Workbook Synopsis

This workbook, which is intended for Oracle Site Activate customers, lists all the open(available to be worked on) activities within Oracle Site Activate and each activity's age(i.e., how long each activity has been open).

Dashboards and Sheets

Open Activities

This worksheet lists all the open (available to be worked on) activities within OracleSite Activate and each activity's age (i.e., how long each activity has been open) aswell as the primary and backup resources assigned to an artifact activity.

Multiple filters to the right allow you to subset the data to your preference. For in‐stance, you can use the "Assigned User Role" filter to identify unassigned open activi‐ties. Using this filter can help to highlight the full amount of remaining work.

Open Activities Export

This worksheet lists additional details for the activities and can be used for exportto .csv format. Use the filters to the right to subset the details sheet to specific activi‐ties, users, date range, etc.

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Chapter 10

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11Quarterly Business Review

Dashboard Synopsis

The Quarterly Business Review Dashboard, intended for Oracle Site Activate custom‐ers, provides rich visuals around study site and user provisioning, as well as site fun‐nel and milestone planning performance. This dashboard can be leveraged as an easyto read reference for presentations.

Dashboards and Sheets

Ramp-up Metrics

This site funnel view provides high level metrics of total sites being managed in OracleSite Activate through sites currently in activation.

Studies by Country

Number of studies in each country visualized in a bar graph and global map. Clickingon any country will enable drill down for details. Study progression over time showsthe last four month's progress.

Filter by region, therapeutic area, study name, and by first site in country date (thedate the study first was active in a certain country).

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Sites by Country

Number of sites in each country visualized in a bar graph and global map. Clicking onany country enables drill down for details. Site progression over time shows the lastfour month's progress.

Filter by region, therapeutic area, study status, study, and site created date.

Site Users by Country

Number of site users in each country visualized in a bar graph and global map. Click‐ing on any country enables drill down for details. Users added over time is broken outby internal and site experience users, and progression over time shows the last fourmonth's progress.

Filter by study and user created date.

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Country and Site Level Milestone Planning

Bar graph broken out by region (or ability to toggle to break out by country) for numberof weeks it takes to plan milestones.

A tree map directly below each bar indicates the portion of the specified milestone thatis:

• Completed early

• Completed on time

• Completed late

• Unplanned completed

• Unplanned open

• Past Due

Operational Metrics

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The site experience user participation chart (broken out by region or country as speci‐fied in the filters to the right of the chart) shows site activities available to complete andhow many were completed by a site experience user. Activities that come in throughquarantine are considered “completed by the site.” This page can be configured basedon Oracle Site Activate role (e.g., Site Coordinator is a typical role that would have siteactivities assigned).

The Activity completed date filter enables the ability to compare this data in differenttime frames.

Chapter 11

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12Regulatory Submissions and Approval Sta‐tus

Workbook Synopsis

This workbook, intended for Oracle Site Activate customers, shows country and sitesubmission and approval activities and status, as well as all documents associatedwith a submission package.

Dashboards and Sheets

Regulatory Submission and Approval Status

This worksheet shows the submission and approval activities for all submissions in astudy and includes the most recent note related to the submission, if available. Hoverover tool tips, in the Initial Submission and Final Approval columns, provide summarydetail.

Click on submission dates on the Regulatory Submissions and Approval Status work‐sheet, the sites associated with the country submission (if any) display in a table at thebottom of the worksheet.

This sheet provides multiple filters to allow users to drill to the preferred view. Filtersare: Study Status, Portfolio, Study Name, Country, Site Status, Site Name, SubmissionLevel, Submission, Submission Version, Protocol Version, Submission Version ID,Submission Type, Submission Category, and Submission Status.

Regulatory Submission Package Details

This worksheet lists all the documents included in the associated submission packagealong with the document status. Use the filters, to the right, to search for specific docu‐ments or filter for documents that are not yet completed.

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Export Regulatory Submission & Approval Status

This worksheet, which is intended for export, provides detailed submission and appro‐val status information, including detailed notes related to the submission reason. Theworksheet includes multiple filters that allow you to adjust content prior to download.

Export Regulatory Submission Package Details

This worksheet, which is intended for export, provides detailed study submission pack‐age information. The worksheet provides multiple filters that allow you to adjust con‐tent prior to download.

Chapter 12

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13Resource Allocation

Workbook Synopsis

This workbook shows users assigned to sites across all studies within Oracle Site Acti‐vate and can be used to identify where resources are overloaded and also unas‐signed. This workbook also provides an export option.

Resource Allocation by Study

This sheet shows resources assigned to studies in Oracle Site Activate, grouped bycountry or user. You can filter the data using the options to the right (Study Name,Study Status, Country Name, etc.).

Resource Assignments by User

This sheet identifies which users are assigned to business roles within a study and in‐cludes site experience users and users with primary assignment flags. You can filterthe data using the options in the filter panel displayed to the right.

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Export Sheet

The export sheet provides an convenient way to download resource allocation detail.By default, all previously applied filters will be applied to the export sheet.

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14Site IP Release Package

Workbook Synopsis

The Site IP Release Package Dashboard, intended for Oracle Site Activate customers,provides high-level metrics related to site IP release package status and delivery per‐formance, as well as detailed data for individual site IP release packages. The dash‐board allows users to quickly identify sites without release packages started, or siteswhere packages require further follow-up, and drill down and export the details forthese specific packages.

Dashboards and Sheets

Site IP Release Metrics

This worksheet includes:

• Percentage of sites with packages started

• Percentage of packages approved after the first review cycle

• Percentage of packages in progress that were not approved after the first reviewcycle

• Number of packages approved over time (line graph) median time from packagedefined to approved over time (bar graph)

• Defined to approved cycle time This quarter vs last quarter

• Break down of package delivery performance

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Site IP Release Package Review and Detail

Click on any row in the worksheet above to view the details on the Site IP ReleasePackage Dashboard tab:

• Crosstab detail of site IP release package review details

• Site planning and delivery details

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• Time spent on each package activity, by percentage

• Documents included in review

• Review status

Site IP Release Package Cycle Details

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Click any row in the report above to view the details on the Site IP Release PackageDashboard tab:

Site IP Release Package Milestone Details

Release Package Document Status

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Export Detail

The export detail worksheet is intended for raw data download to CSV. The sheetdoes not include filters or other interactive elements.

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15Site Reconciliation

Workbook Synopsis

The Site Reconciliation Dashboard provides metrics to help managers understand theusage of sites in the Oracle Site Activate system as related to your Master ServicesAgreement. Standard Tableau functionality allows managers to easily download thedashboard and associated worksheets for further analysis or distribution.

Dashboard and Sheets

Site reconciliation dashboard

The Sites Dashboard tab provides a trend chart to visualize site fees over time as wellas a Rate Card table view of individual and total fees by type, contract, site type, etc.over a selected time period. Managers have multiple filter options to create a preferredview - including filters like Contract, Site Status, Date Range, and more. Finally, thedashboard prominently displays site and fee metrics for the specified Date Range.These metrics include Total number of sites, Total deleted sites, and Total fees,among others. To export the dashboard, use Tableau's standard Download option.

Sites detail sheet

The Sites Detail worksheet, which is intended for export use only, provides compre‐hensive information about sites as grouped by site type and study name. For instance,the worksheet includes details like site created date, site license expiration date, mile‐stone dates, and days until the site will be dropped. To export this worksheet, use Ta‐bleau's Download option located just above the filters panel.

Rate card sheet

The Rate Card worksheet includes the same rate data presented in the Sites Dash‐board tab, broken out into a separate sheet. Managers can adjust the data displayedusing standard filter controls located to the far right. For instance, filter controls includeContract, Fee Type, Site Type, and Date Range, among others. Use the Download op‐tion, located just above the filter panel, to export and distribute Rate Card informationas necessary.

Site status history

The Site Status History worksheet provides details of changes to a site's status (e.g.,In activation, IP released, Dropped, etc.) and allows managers to easily view changesto a site's status over time. This sheet provides several filters (Study Status, StudyName, Country Name, Site Number, Site Type, and Current Site Status) that allowmanagers to create a preferred view. To export this worksheet, use Tableau's Down‐load option located just above the filters panel.

Study status history

The Study Status History worksheet allows managers to easily view study statuschanges over time. Managers have the option to filter the sheet's data to one or morestudy, and columns included in the sheet are sortable to reach a preferred view. Col‐umns include: Study Name, Study Status, Study Created At date, Prior Status, Status,

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and Set/End Dates. To export this worksheet, use Tableau's Download option locatedjust above the filters panel.

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16Study Startup Industry Benchmarking

Workbook Synopsis

This dashboard gives Oracle Site Analyze users insight into their own organization’scycle-time performance relative to others in the industry. Benchmarks are available bycountry and therapeutic area. Currently, this dashboard focuses on three cycle timesfor Oracle Site Activate:

1. Essential docs sent to site - Contracts executed

2. Contracts executed - IP release ready

3. Essential docs sent to site - IP release ready

Dashboards and Sheets

Industry Benchmarking Dashboard

The upper portion of the dashboard displays your statistics: site count by country, sitecount by therapeutic area, and site count by study phase. Using the options to theright, you can filter the dashboard by study status, study name, therapeutic area, re‐gion, country, institution, cycle end date, and minimum number of cycles completed.You can also optionally exclude negative cycle times from the dashboard's calcula‐tions.

The lower section of the dashboard provides the median cycle time comparison be‐tween your performance and the Oracle industry benchmark. Select a Key Cycle andUnit of Measure from the drop-down menus above the graph. Hover over any bargraph to view additional information about cycles and efficiency.

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Cycle Analysis Dashboard

The second tab in the Study Startup Industry Benchmarking workbook is a cycle anal‐ysis dashboard. The upper portion of the dashboard includes a tabular version of thecycle time diagrams at the bottom of the dashboard. You can quickly see the exactvalues of the industry medians compared with your account medians.

The lower section of the dashboard displays median cycle time vs. industry benchmarkas a whisker plot diagram. Hover over any star to view the Oracle industry benchmark.Hover over any circle to view your own median cycle time over cycles. Hover over anybar to view upper, median, and lower values.

You can also filter using any of the filter drop-down options: Key Cycle, Slice Data By(Therapeutic Area or Country), Compare Data By (PI, Country, Region, and more),and Unit of Measure. You can also sort the table using the drop-down control.

Data Export Worksheet

The data export worksheet includes a downloadable version of your data used to cre‐ate benchmarking comparisons. You can optionally filter this data prior to download byStudy Status; Study Name; Therapeutic Area; Region; Country; Institution; and num‐bered range of Essential Docs Sent to Site to Contracts Executed, Contracts Executedto IP Release, and/or Essential Docs Sent to Site to IP Release.

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17Study Summary

Workbook Synopsis

The Study Summary workbook, which is intended for Oracle Site Activate customers,provides easy interpretation of overall study status; visibility into unplanned, past due,and upcoming milestones; and milestone and submissions progress at the country andsite level. Detailed sheets, described below, complement the Study KPIs dashboardsheet, enabling report users to quickly pinpoint milestones and submissions that areupcoming or past due.

Dashboards and Sheets

Study KPI Dashboard

This dashboard provides a high level graphical view of progress to plan over time formilestones and submissions. Hover-over tool tips for circle and bar graphs provide ad‐ditional details. You can filter the dashboard by: Study Status, Portfolio, Study Name,Country, Site Status, Site Name, Milestone Group, Milestone, and date range.

Milestone KPI Dashboard

The Milestone KPI dashboard allows comparison of up to three milestones at onetime. Top level KPIs show:

• % planned to actual - total number of milestones completed divided by the totalnumber of milestones planned up to the current day

• % actual to total - total number of milestones completed divided by the total num‐ber of milestones created

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Study Summary

This worksheet provides a detailed tabular view of country and site global milestones,broken down by month, over the length of the study to date. This data is a detailedrepresentation of the high-level graphical representation in the Study KPI dashboard.

You can filter this worksheet for a particular global milestone, or for any number ofglobal milestones. This dashboard can also be filtered to look at data for the durationof the study to date, or other date range.

Country Milestones

This sheet details country milestone data by site and milestone dates. Hover over tooltips (over the red and green boxes) provide additional information, such as "Latest re-plan note," if appropriate. You can filter this sheet by Study Status, Portfolio, StudyName, Country, Milestone Group, Milestone, Milestone Status, and date range.

You can also access notes related to country milestones on this sheet.

• Click on a country milestone and the most recent reason for change and the mostrecent country note will display at the bottom of the dashboard

• Click on a country name and a link will display in the tooltip that you can click on tobe taken the All Notes worksheet, which will display all notes for that country

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• Click on a country name and a link will display in the tooltip that you can click onand be taken the All Notes worksheet, which will display all notes for the countrymilestones

Country Submissions

This dashboard details study country regulatory submissions data. Hover over tool tips(over the red and green boxes) provide additional information, such as "Latest re-plannote," if appropriate. You can filter this sheet by Study Status, Portfolio, Study Name,Country, Submission, Milestone Group, Milestone, Milestone Status, and date range.

You can also access notes related to country submissions on this sheet.

• Click on a country submission and the most recent artifact/activity note related tothat submission and the most recent country note will display at the bottom of thedashboard

• Click on a country name and a link will display in the tooltip that you can click on tobe taken the All Notes worksheet, which will display all notes for that country

• Click on a country name and a link will display in the tooltip that you can click onand be taken the All Notes worksheet, which will display all notes for the countrysubmissions

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Site Milestones

This worksheet details completed and past due milestones at the site level. Hover overtool tips (over the red and green boxes) provide additional information, such as "Latestre-plan note," if appropriate. You can filter this sheet by Study Status, Portfolio, StudyName, Country, Site Status, Site Name, Milestone Group, Milestone, Milestone Status,and date range.

You can also access notes related to site milestones on this sheet.

• Click on a site milestone and the most recent reason for change and the most re‐cent site and country notes will display at the bottom of the dashboard

• Click on a site name and a link will display in the tooltip that you can click on to betaken the All Notes worksheet, which will display all notes for the site

• Click on a site and a link will display in the tooltip that you can click on and be tak‐en the All Notes worksheet, which will display all notes for the site milestones

Site Submissions

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This worksheet details completed and past due submissions at the site level. Hoverover tool tips (over the red, green, and white boxes) provide additional information,such as "Latest re-plan note," if appropriate. You can filter this sheet by Study Status,Portfolio, Study Name, Country, Site Status, Site Name, Submission, Milestone Group,Milestone, Milestone Status, and date range.

You can also access notes related to site submissions on this sheet.

• Click on a site submission and the most recent artifact/activity name and the mostrecent site and country notes will display at the bottom of the dashboard

• Click on a site name and a link will display in the tooltip that you can click on to betaken the All Notes worksheet, which will display all notes for the site

• Click on a site and a link will display in the tooltip that you can click on and be tak‐en the All Notes worksheet, which will display all notes for the site submissions

Study Artifacts

The Study Artifacts worksheet provides a comprehensive view of artifact status (e.g.,total artifacts completed, % of artifacts completed, in progress, not started, and discon‐tinued, etc.). You can drill into a Study Artifact Dashboard from the Country Mile‐stones, Country Submissions, Site Milestones, and Site Submissions sheets. From theStudy Artifact Dashboard, you can then drill into the Artifact Detail sheet.

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Artifact Detail

The Artifact Details worksheet includes the status of each individual artifact at the site.

All Notes

The All notes worksheet includes detailed note text associated with study artifacts. Us‐ing the options in the filter panel to the far right, you can filter the All Notes worksheetby study status, portfolio, study name, country, site status, and more.

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18Workbook Permissions and User Groups

Workbook Synopsis

The Workbook Permissions and User Groups report provides information related touser accounts and groups setup in Oracle Site Analyze for Oracle Site Activate users.The report lists each user, the group with which the user is associated, and the per‐missions for the workbook(s) associated in that group. This report is intended for man‐agers who are responsible for ensuring that report access across users and groups isproperly assigned.

Report Samples

Workbook Permissions

User Groups

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