Using Oracle Site Analyze: For Oracle Site Activate Users · The Oracle Site Analyze data dictionary is built to provide insight on common study startup tasks. For example, study

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

Release 19.3F23257-01October 2019

Oracle Health Sciences Site Analyze Cloud Service Using Oracle Site Analyze: For Oracle Site ActivateUsers, Release 19.3

F23257-01

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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 Adoption and Compliance

5 All Activities + Notes

6 Analyze Adoption Dashboard

7 Compliance Dashboard

8 Contract Module Dashboard

9 Cycle Times

10

Delivery Dashboard

11

Milestone and Submission Planning

iii

12

Open Activities

13

Quarterly Business Review

14

Regulatory Submissions and Approval Status

15

Resource Allocation

16

Site IP Release Package

17

Site Reconciliation

18

Study Startup Industry Benchmarking

19

Study Summary

20

Workbook Permissions and User Groups

21

Data Export Utility

Create a new export 21-2

View existing export 21-3

Edit existing export 21-3

Delete an export 21-3

iv

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1About the Data Dictionary, Access, andUser Roles

Oracle Site Analyze is the reporting and visualization application that supplementsreports available in the Oracle Site Activate clinical study startup application. Below,we provide 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,documents, 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 adminprivileges)

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 reportshowing planned versus expected study milestones, while cycle time data items giveyou the 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 from Oracle Site Activate or Oracle Site Select

Navigation

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 orOracle Site Select application. In the Oracle Site Activate top navigation bar, clickReports, then click Analyze reports. In the Oracle Site Select top navigation bar, hoverover the Dashboards menu, then click Analyze reports.

Study Level Permissions

For both Oracle Site Activate and Oracle Site Select, you must have study levelaccess to view specific studies in certain reports. Analyze enforces study levelpermissions for the following reports:

Oracle Site Activate

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• All Activities + Notes

• Contract Module Status

• Delivery Dashboard

• Documents and Submissions

• Milestone and Scheduled Activity Planning

• Open Activities

• Regulatory Submissions and Approval Status

• Site IP Release Package Dashboard

• Study Summary Dashboard

Oracle Site Select

• Survey Response Analysis

• Site Study Interest and Exclusion

• Site Progress

• Study Level Notes

Oracle Site Activate Release Compatibility

Please note that Oracle Site Analyze reports are not backward compatible to previousOracle Site Activate releases. Customers who want access to the enhanced reports in19.2 Oracle Site Analyze must upgrade their Oracle Site Activate release to 19.2 aswell. Please contact your Oracle Project Manager or Account Manager for moreinformation about upgrading.

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 SiteAnalyze reports and reports that BI users share with them.

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2About Viewing Reports and Using Tableau

Below we describe the Oracle Site Analyze project dashboard and workbooks anddescribe 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.

For the following reports, Oracle Site Analyze users will view only those studiesthat 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 Status

• Site IP Release Package Dashboard

For the following reports, Oracle Site Analyze users will view only those studiesthat they have permission to view in Oracle Site Select:

• Survey Response Analysis

• Site Study Interest and Exclusion

• Site Progress

• Study Level Notes

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 accessadditional 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

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• Permissions: allows you to determine who can view, interact with, and editreports (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

• 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 Analyzeaccess. However, you can export an Oracle Site Analyze report and send itto those 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

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https://onlinehelp.tableau.com/v10.5/pro/desktop/en-us/data_explore_analyze_interact.html#top

https://onlinehelp.tableau.com/v10.5/pro/desktop/en-us/navigating.html#ViewContent

https://onlinehelp.tableau.com/v10.5/pro/desktop/en-us/save_savework.html#Web

https://onlinehelp.tableau.com/v10.5/pro/desktop/en-us/refresh.html

https://onlinehelp.tableau.com/v10.5/pro/desktop/en-us/subscribe_user.html#SubscribeYourself

https://onlinehelp.tableau.com/v10.5/pro/desktop/en-us/subscribe_user.html#Unsubscribe

• Export data

• Use Custom Views

• Export views

• Share web views

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https://onlinehelp.tableau.com/v10.5/pro/desktop/en-us/help.html#save_export_data.html%3FTocPath%3DDesign%2520Views%2520and%2520Analyze%2520Data%7CSave%252C%2520Revert%252C%2520Export%252C%2520or%2520Print%7C_____3

https://onlinehelp.tableau.com/v10.5/pro/desktop/en-us/help.html?_ga=2.229581724.1080083797.1559163259-1646330200.1559163259#customview.html?Highlight=Custom%20View

https://onlinehelp.tableau.com/v10.5/pro/desktop/en-us/help.html#save_export_image.html%3FTocPath%3DDesign%2520Views%2520and%2520Analyze%2520Data%7CSave%252C%2520Revert%252C%2520Export%252C%2520or%2520Print%7C_____4

https://onlinehelp.tableau.com/v10.5/pro/desktop/en-us/shareworkbooks.html

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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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 thisworkbook. The worksheet provides several filters (e.g., User Name, BusinessRole, Sign in Count, etc.) that allow you to subset the data included in the detailworksheet.

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


Dashboard

Detail

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4Adoption 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, andcompliance. With a layout designed for quick review and ideal for email subscriptions,it includes access to the underlying tabular data that drives the dashboardvisualizations when deeper analysis is required.

Dashboard and Sheets

About

The About sheet provides a summary of key report features to help Adoption andCompliance report users understand if the report is applicable to his or her role. TheAbout sheet provides details like:

• Study startup roles that would use the report

• Key report features and metrics

• Types of data the report contains

• Examples of how to use the report to answer a business question

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

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• % 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

• 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

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Studies Detail

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

Sites Detail

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.

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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 Datefilters 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.

Activation Compliance Detail

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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 usersadded over time. Use the User Name and/or Created Date filters to adjust the view.

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.

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User Logs Detail

This worksheet includes login details, by user. Use User Type (internal or siteexperience), 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.

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

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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.

Completed Milestones Detail

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

Activities Detail

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This worksheet includes activity details like artifact name, activity name (e.g.,document received/reviewed, complete document upload, etc.), completed date,activity completed by (user), and more. Use Study, Study Status, Site Status, SiteNumber, Activity Role, Activity Completed By (user), and Completed Date filters toadjust the view.

Site Activities Detail

This worksheet includes activity details, by site experience users.

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5All 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. Thesecond worksheet lists the notes entered for artifact activities within Oracle SiteActivate. Two export worksheets can be used to download the activities and notesdata.

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,clinical 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, site

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name, user, and more. You can also filter the worksheet by Note Type (All, Activity,Artifact, General Country, and/or General Site).

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 theentire 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 todownload.

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.

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6Analyze Adoption Dashboard

Workbook Synopsis

Using the Analyze Adoption Dashboard, Oracle Site Activate customers can easilymonitor the adoption of Oracle Site Analyze within their organizations to understandwhich reports are used most frequently and which users log into the application mostoften.

Analyze Adoption

The Analyze Adoption sheet includes a trend graph in the upper section, with:

• Number of views per year, quarter, month, week, day

• Number of distinct user logins per year, quarter, month, week, day

Report users can hover over a bar in the trend graph to view date and distinct usercounts.

The report's lower section includes three horizontal bar charts, all of which act as filterswhen clicked:

• Number of views by workbook

• Number of views by worksheet

• Number of views by user

Detail

The Analyze Adoption Dashboard also includes a "Detail" sheet, which report userscan access directly or drill into from the Analyze Adoption sheet. The Detail sheetprovides the following data in tabular format:

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• Date viewed

• Project

• Workbook name

• View name

• User name

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7Compliance Dashboard

Workbook Synopsis

Intended for Oracle Site Activate customers, the Compliance Dashboard allows OracleSite Activate administrators and stakeholders to understand if users are taking fulladvantage of the system by monitoring whether users are actively entering incompletion dates and accurately entering in planning dates.


About

The About sheet provides a summary of key report features to help ComplianceDashboard users understand if the report is applicable to his or her role. The Aboutsheet provides details like:





Executive Summary Dashboard

This dashboard is a high-level summary of overall milestone date entry complianceand milestone planning accuracy compliance. The top of the dashboard includes atrend chart showing the total median milestone entry delay or the total medianmilestone planning accuracy across all Oracle Site Activate by week/month/quarter/year. The bottom table can be adjusted to a preferred view using several parameters:

• "slice data by" all Oracle Site Activate, portfolio, region, country, study, globalmilestone, user

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• "compare data by" all Oracle Site Activate, portfolio, region, country, study, globalmilestone, user

• a slider filter allows a user to control the compliance threshold

• "select a metric" allows a user to toggle the table between entry delay andplanning accuracy

User Activity Dashboard

This dashboard allows for tracking actions of Oracle Site Activate users over time. Theupper section of the worksheet displays a sortable table with a single row per user.Each user has the following metrics per row:

• total activities completed in Oracle Site Activate

• total notes created in Oracle Site Activate

• total artifacts created in Oracle Site Activate

• median delay in days from milestone completed date to milestone entered date

• average delay in days from milestone completed date to milestone entered date

• total milestones entered in Oracle Site Activate

The lower section of the dashboard displays a trend graph with the option to trend to:

• Activities

• Artifacts Created

• Delay

• Milestones Entered

• Notes

When a report user clicks on a user name in the top table, it will filter the bottom trendchart to only show that user.

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Milestone & Submission Planning Accuracy

This worksheet allows report users to compare the baseline milestone date to theactual milestone date to understand how accurate the organization is in planningmilestones and identify areas for improvement. The upper portion of the worksheetincludes six top-level KPIs that show median of baseline to actual. Report users candynamically select any milestone or submission from a drop-down list.

The lower section of the worksheet includes a bar graph and table that are controlledby two parameters:

1. Slice Data - shows which dimension drives the graph and table - study, region,country, portfolio

2. Select a KPI - shows which milestone or submission will be used for the graph andtable

The graph and table metrics are the median of baseline to actual for the selecteddimension.

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Milestone & Submission Entry Delay

This worksheet is similar to the Planning Accuracy sheet described above, but thissheet focuses on comparison of the actual milestone date to the date the milestonewas entered. This worksheet is intended to help report users understand if Oracle SiteActivate users are entering data into the system in a timely manner. The upper portionof the worksheet includes six top-level KPIs that show median of actual to dateentered. Report users can dynamically select any milestone or submission from adrop-down list.

The lower section of the worksheet includes a bar graph and table that are controlledby two parameters:

1. Slice Data - shows which dimension drives the graph and table - study, region,country, portfolio

2. Select a KPI - shows which milestone or submission will be used for the graph andtable

Graph and table metrics are the median of actual to date entered for the selecteddimension.

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8Contract Module Dashboard

Workbook Synopsis

Intended for Oracle Site Activate customers, the Contract Module Dashboardcomplements the Oracle Site Activate contract module. This report helps contractmanagers and specialists access the information they need about site contractprogress. Managers can use the dashboard to view contract analyst workload. Userscan access additional activity data through the dashboard and filter it based onselection.


About

The About sheet provides a summary of key report features to help Contract ModuleDashboard users understand if the report is applicable to his or her role. The Aboutsheet provides details like:





Site Contract Status

This worksheet is intended to help report users understand the status of all sitecontracts and budgets to identify areas of risk and ensure the study stays on schedule.A top trend graph indicates the site contract executed milestone by baseline, planned,and actual dates. A stacked bar graph allows report users to select the agreementtype, and a selectable parameter allows report users to slice agreement status by all,

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region, country, study, or portfolio. Additionally, a color coded, stacked bar chartindicates contract status (e.g., not started, in negotiation, etc.).

Site Contract Activity

This worksheet allows report users to see the detailed activity history of contractartifacts to easily track contracts that have not been completed and what action needsto be completed next.

Site Contract Details

This worksheet includes a tabular view of metadata associated with the site contract(e.g., contract group, effective date, contracting party, etc.).

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Site Budget Details

This worksheet includes a tabular view of metadata associated with the site budget(e.g., agreement, currency, total one time up front fees, etc.).

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9Cycle Times

Workbook Synopsis

This Cycle Times Dashboard, which is intended for Oracle Site Activate customers,includes 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.


About

The About sheet provides a summary of key report features to help Cycle TimesDashboard users understand if the report is applicable to his or her role. The Aboutsheet provides details like:





Key Cycles

The Key Cycles report provides an at-a-glance view of four key Oracle Site Activatecycle times in a single dashboard view. Report users will specify the start level, startpoint, end level, and end point for each of the four key cycles. The key cycles displayin a horizontal row with the number of cycles, median cycle time, and a box andwhisker plot controlled by a "Compare your data by" parameter. Report users can also

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optionally adjust the view to day, week, or month.

Cycle Analysis

The Cycle Analysis report provides deeper insight into a single key cycle. This sheethelps report users identity operational strengths and weaknesses that may lead tobusiness process changes and faster cycle times in the future. Parameters that controldata display on this sheet are:

• Select a cycle (start level, start point, end level, end point)

• Slice your data by: All, Portfolio, Region, Country, Study, Therapeutic Area, StudyPhase, PI Name

• Compare your data by: All, Portfolio, Region, Country, Study, Therapeutic Area,Study Phase, PI Name

• Choose unit of measure: Day, Week, Month

• Sort table by: Data Slice, Number of Cycles, Median Cycle

The upper section of the analysis sheet presents data in a tabular format with drill todetail functionality, while the lower section of the report presents data in a box andwhisker plot format (dimensions based on "Slice data by" parameter and dots basedon "Compare data by" parameter).

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Cycle Trends

The Cycle Trends report simplifies viewing cycle performance over time. On this sheet,report users will specify the start level, start point, end level, and end point for the keycycle for which trending displays. Additional parameters for display are:

• Slice your data by: All, Portfolio, Region, Country, Study, Therapeutic Area, StudyPhase, PI Name

• Choose unit of measure: Day, Week, Month

• Sort table by: Data Slice, Number of Cycles, Median Cycle

The upper section of the Cycle Trends sheet presents data in a tabular format. Thelower section's trend graph is a line chart that renders the median cycle time based onselected parameters.

Cycle Detail

The Cycle Detail includes a table with the following data:

• Study

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• Country

• Site

• Cycle start point

• Cycle start actual date

• Cycle end point

• Cycle end actual date

• Cycle time

Report users can drill into the Cycle Detail sheet from the Key Cycles and CycleAnalysis sheets.

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10Delivery Dashboard

Dashboard Synopsis

The Delivery dashboard, which is intended for Oracle Site Activate customers, isbroken 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.


Work Remaining


• Milestones to be completed over time: cell color will be darker where moremilestones are planned to be completed. Cell which contain a red ‘X’ aremilestones that are overdue.

• Delivery performance: tree map compares milestones that are:

– Overdue – Blocked: milestones that are incomplete after planned date thatrequires 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 differentattributes.

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Work Completed


• Milestones to be completed over time: cell color will be darker where moremilestones 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 differentattributes.

Chapter 10

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11Milestone and Submission Planning

Workbook Synopsis

Intended for Oracle Site Activate customers, this workbook lists all the baseline,planned, and completed dates for all milestones and submissions within Oracle SiteActivate.


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 toadjust data included in the report by Study Name, Country, Site Info, Event Name,Event Level, 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,Country, Submission Type, and more.

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Chapter 11

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12Open 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).


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. Forinstance, you can use the "Assigned User Role" filter to identify unassigned openactivities. 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 specificactivities, users, date range, etc.

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Chapter 12

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13Quarterly Business Review

Dashboard Synopsis

The Quarterly Business Review Dashboard, intended for Oracle Site Activatecustomers, provides rich visuals around study site and user provisioning, as well assite funnel and milestone planning performance. This dashboard can be leveraged asan easy to read reference for presentations.


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).

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

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Number of site users in each country visualized in a bar graph and global map.Clicking on any country enables drill down for details. Users added over time is brokenout by internal and site experience users, and progression over time shows the lastfour month's progress.

Filter by study and user created date.

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

The site experience user participation chart (broken out by region or country asspecified in the filters to the right of the chart) shows site activities available tocomplete and how many were completed by a site experience user. Activities thatcome in through quarantine are considered “completed by the site.” This page can beconfigured based on Oracle Site Activate role (e.g., Site Coordinator is a typical rolethat would have site activities assigned).

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

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14Regulatory Submissions and ApprovalStatus

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.


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 Statusworksheet, the sites associated with the country submission (if any) display in a tableat the bottom 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 specificdocuments 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 andapproval status information, including detailed notes related to the submission reason.The worksheet includes multiple filters that allow you to adjust content prior todownload.

Export Regulatory Submission Package Details

This worksheet, which is intended for export, provides detailed study submissionpackage information. The worksheet provides multiple filters that allow you to adjustcontent prior to download.

Chapter 14

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15Resource Allocation

Workbook Synopsis

This workbook shows users assigned to sites across all studies within Oracle SiteActivate and can be used to identify where resources are overloaded and alsounassigned. The workbook also provides worksheets that help report users track andmanage assignment of user roles and business permissions in Oracle Site Activate.

About

The About sheet provides a summary of key report features to help ResourceAllocation report users understand if the report is applicable to his or her role. TheAbout sheet provides details like:





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.).

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Role Assignment by User

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

Data Export

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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Business Role Definitions

The Business Role Definitions sheet presents a simple columnar view of business rolename and the list of all permissions currently enabled for the role. The ResourceAllocation report also includes a "Business Role Definitions Export" sheet you can useto export the business role information.

User Roles and Permissions

The User Roles and Permissions" sheet shows which business roles a user isassigned even if they are not assigned to a study, country, or site. You can also usethis new sheet to view which user level settings an individual user has assigned. Thesheet includes:

• User name

• Role type (business role or system role)

• List of business and system roles that user is assigned

A User Roles and Permissions Export sheet designed exclusively for export of theroles and permissions data is also available in the Resource Allocation report.

Chapter 15

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Chapter 15

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16Site IP Release Package

Workbook Synopsis

Intended for Oracle Site Activate users, the Site IP Release Package Dashboardworkbook allows report users to see granular package and document statuses, as wellas understand the state of all IP release packages for a study.


About

The About sheet provides a summary of key report features to help Site IP ReleasePackage report users understand if the report is applicable to his or her role. TheAbout sheet provides details like:





Release Package Review

This dashboard is a high-level summary of overall status of all IP release packages,with a breakdown of package review status and rejection reasons.

The top of the dashboard displays the following top-level KPIs (based on activity typeas specified in the Activate lifecycle):

• release package milestone status (derived from the milestone)

– not planned

– past due

– due next 15 days

– completed

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• release package review status (derived from the lifecycle)

– not started

– defined

– reviewed

– approved

A trend graph, in the middle section of the dashboard, shows a comparison ofbaseline, planned and actual IP Release ready milestone dates. The bottom of thedashboard includes two bar charts - with the left bar chart showing package status andthe right bar chart showing reasons for package rejection.

Release Package Document Review

This dashboard allows users to understand most the most common documents in apackage as well as the most commonly rejected documents and their reasons forrejection.

At the top of the dashboard, a horizontal bar chart displays the count or percentage ofdocument name included in a package, sorted in descending order. Each of the barsin this upper chart acts as a filter for data displayed in the lower section of thedashboard.

The lower section is divided into three horizontal bar charts as follows:

• The lower left chart shows the breakdown of document review status

• The lower middle chart shows the rejection ratio per parameter selected (portfolio,study, region, country, all)

• The lower right chart shows the count of document rejection reasons

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Release Package Details

This worksheet shows a user the details of the review package, including package andreview status.

Release Package Document Details

This worksheet shows a user the details of the documents included in the reviewpackage, including package status, document status, and rejection reasons.

Chapter 16

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Data Export

This worksheet allows a report user to export the package details to Excel or CSV.

Chapter 16

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17Site 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, providescomprehensive information about sites as grouped by site type and study name. Forinstance, the worksheet includes details like site created date, site license expirationdate, milestone dates, and days until the site will be dropped. To export thisworksheet, use Tableau's Download option located just above the filters panel.

Rate card sheet

The Rate Card worksheet includes the same rate data presented in the SitesDashboard tab, broken out into a separate sheet. Managers can adjust the datadisplayed using standard filter controls located to the far right. For instance, filtercontrols include Contract, Fee Type, Site Type, and Date Range, among others. Usethe Download option, located just above the filter panel, to export and distribute RateCard information as 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'sDownload 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.Columns include: Study Name, Study Status, Study Created At date, Prior Status,

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

Chapter 17

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18Study 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


About

The About sheet provides a summary of key report features to help users understandif the report is applicable to his or her role. The About sheet provides details like:





Industry Benchmarking Dashboard

Report Card

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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,region, country, institution, cycle end date, and minimum number of cycles completed.You can also optionally exclude negative cycle times from the dashboard'scalculations.

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

Cycle Analysis

The second tab in the Study Startup Industry Benchmarking workbook is a cycleanalysis dashboard. The upper portion of the dashboard includes a tabular version ofthe cycle 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.

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Cycle Trends

The Cycle Trends sheet allows report users to easily evaluate performance over timeand compare the user's organization cycle times to industry cycle times by month,quarter, or year. Trend data is presented in line graph format in the lower section ofthe report, and the upper section presents columns for the following data points:

• trend by parameter

• your number of cycles

• your cycle median

• industry number of cycles

• industry median

When a report user clicks a data point in the upper section (e.g., user clicks on acountry name or a Benchmark Median count), the trend graph below displays the datapoint in the graph. Users can then hover over points in the graph to view median,benchmark median cycle time, and/or their organization's median cycle time.

The report also includes a toggle in the filter selection panel that allows user to easilyinclude and exclude their own data from the industry benchmark for therapeutic areasand countries.

Chapter 18

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Cycle Detail

The Cycle Detail worksheet includes a tabular view of data used to create cyclebenchmarking comparisons.

Chapter 18

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19Study 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.


About

The About sheet provides a summary of key report features to help Study Summaryreport users understand if the report is applicable to his or her role. The About sheetprovides details like:





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 provideadditional details. You can filter the dashboard by: Study Status, Portfolio, StudyName, Country, Site Status, Site Name, Milestone Group, Milestone, and date range.

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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 totalnumber of milestones created

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.

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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

• 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.

Chapter 19

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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

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 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 betaken the All Notes worksheet, which will display all notes for the site milestones

Chapter 19

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Site Submissions

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 betaken the All Notes worksheet, which will display all notes for the site submissions

Study Artifacts

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

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.Using the options in the filter panel to the far right, you can filter the All Notesworksheet by study status, portfolio, study name, country, site status, and more.

Chapter 19

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Chapter 19

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20Workbook 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 thepermissions for the workbook(s) associated in that group. This report is intended formanagers who are responsible for ensuring that report access across users andgroups is properly assigned.

Report Samples

Workbook Permissions

User Groups

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21Data Export Utility

The Oracle Site Analyze Data Export Utility for Oracle Site Activate is a self-serviceexport that allows permissioned Oracle Site Activate users to design a CSV extractthat contains their chosen data columns and filters. Currently, the extract includescubes (i.e., a multi-dimensional array of data) for:

• Study Sites

• Study Artifacts

• Study Level Documents

• Study Milestones and Submissions

Required Permission

Oracle Site Activate users must have at least one business role with “Enable access tothe Data Export Utility” permission to access the new export feature from the OracleSite Activate Reports menu. If you do not have this permission, the Data Export optiondoes not display in the Reports drop-down menu; please contact your super user oradministrator.

The Data Export Utility allows you to create new extracts based on:

• Cube - The available data cubes are:

– Study Sites

– Study Artifacts

– Study Level Documents

– Study Milestones and Submissions

• Columns (dimensions) - Columns can be added in any order

• Filters - Filters can be added in any order

The Data Export Utility will notify you if the columns and filters you select for theextract will not result in matching records.

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• Create a new exportIf you have the appropriate business role permission in Oracle Site Activate, youcan access the Data Export Utility to create a unique export that contains yourpreferred data then export the result to a .csv format file.

• View existing exportThe Data Export Utility page lists all of your previously-created reports that youcan view, if desired.

• Edit existing exportThe Data Export Utility page lists your all previously-created reports that you canedit as preferred.

• Delete an exportThe Data Export Utility page lists all of your previously-created reports. When anexisting report is no longer relevant, you can delete it as necessary.

Create a new exportIf you have the appropriate business role permission in Oracle Site Activate, you canaccess the Data Export Utility to create a unique export that contains your preferreddata then export the result to a .csv format file.

1. From the Activate top navigation, hover over Reports and click Data export.

2. On the Data export reports page, click New Report.

3. On the New Report pop-in, choose Study Sites Cube, Study Artifacts Cube,Study Level Documents Cube, or Study Milestones and Submissions Cubedata from the drop-down list.

4. Click Continue.

5. At the top of the pop-in, enter your preferred Report name.

6. Under "Columns added," choose the dimensions you would like to add ascolumns. You can scroll through the list of available dimensions or search for aspecific dimension. As you add dimensions, the "Columns added" count increases.

7. Click "Filters added." By default, the Study Name is required and will be pre-populated as a filter. You can export for only one study per report. Enter the studyname. To add additional filters, choose a field from the drop-down menu. Enter atext value to filter by. All text values are wildcard and case sensitive.

8. Click Save and Preview.

9. At the upper right, click Export to generate a CSV file, or click Edit Report toadjust the report data before exporting.

Chapter 21Create a new export

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View existing exportThe Data Export Utility page lists all of your previously-created reports that you canview, if desired.

1. From the Oracle Site Activate top navigation, hover over Reports and click Dataexport.

2. On the Data export reports page, locate the report to be edited.

3. To the far right, click View.

Edit existing exportThe Data Export Utility page lists your all previously-created reports that you can editas preferred.



3. To the far right, click Edit report.

4. Adjust the report name, columns, and/or filters as preferred.

5. Click Save and Preview.

6. At the upper right, click Export to generate a CSV file, or click Edit Report toadjust the report data before exporting.

Delete an exportThe Data Export Utility page lists all of your previously-created reports. When anexisting report is no longer relevant, you can delete it as necessary.



3. To the right, click the trash can ( ).

Chapter 21View existing export

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