Oracle® Health Sciences Site AnalyzeCloud ServiceRelease Notes

Release 19.1F20402-01July 2019

Oracle Health Sciences Site Analyze Cloud Service Release Notes, Release 19.1

F20402-01

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Contents

1 Report Enhancements for Oracle Site Activate

2 New Fields for Oracle Site Activate

3 Service Notes for Oracle Site Activate

4 New Report for Oracle Site Select

5 Report Enhancements for Oracle Site Select

6 Data Export Utility for Oracle Site Select

7 Service Notes for Oracle Site Select

8 Stability Improvements

Infrastructure 8-1

Oracle Site Select Oracle Site Analyze Reports 8-1

9 Priority Definitions

10

Technical Information

Browser Support 10-1

Support Transition Notice 10-1

iii

Documentation Accessibility

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4

1Report Enhancements for Oracle Site Acti‐vate

Adoption and Compliance Dashboard

With this release, we updated the Adoption and Compliance Dashboard milestone sta‐tus color scheme to align with other Oracle Site Activate reports. For example, pastdue milestones now display in red.

We also added “SC” (Site Coordinator) role as a site experience user role in the Adop‐tion and Compliance dashboard to ensure these users are included in calculations forsite experience users.

Regulatory Submissions and Approval Status Report

We enhanced the Regulatory Submissions and Approval Status report to allow usersto see the sites associated with a country submission. Now, when a user clicks onsubmission dates on the Regulatory Submissions and Approval Status worksheet, thesites associated with the country submission (if any) display in a table at the bottom ofthe worksheet.

Site fields in the new table are: Submission Info, Country, Site Number, PI First NamePI Last Name, Institution, Site Status, IRB/EC Type, and Site Approved.

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Site IP Release Package Dashboard

We enhanced the Site IP Release Package Dashboard worksheet to include OracleSite Activate color-coded Review Status (i.e., First Review, Final Approval, Rejected.)in the lower section of the worksheet, as well as a new Review Status filter. We alsoremoved color coding from Document Status in the lower section of the worksheet.

Chapter 1

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We enhanced the Release Package Document Status worksheet to include new col‐umns for “Review Status Note Attributes,” “Review Status Notes,” and “Review Sta‐tus.” We also added new “Review Status” filter on this worksheet.

Study Startup Industry Benchmarking Dashboard

In this report, the Cycle Analysis worksheet has been redesigned to include a tabularversion of cycle time box-plot diagrams at the top of the worksheet (replacing thebenchmark and median KPIs). This enhancement allows report users to quickly viewthe exact values of the industry medians compared with the user’s account medians.

We also added a legend for the Cycle Analysis worksheet box plot, at the lower right,to help users understand the components, and we added a horizontal axis showing therange of days or weeks (depending upon selected unit of measure filter).

Chapter 1

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Study Summary Dashboard

With Release 19.1, we enhanced the Study Summary Dashboard report to allow usersto easily drill down to individual artifact details from country and site milestone andcountry and site submissions worksheets. This enhancement includes adding two newworksheets to the report:

• Study Artifacts - provides a comprehensive view of artifact status (e.g., total arti‐facts completed, % of artifacts completed, in progress, not started, and discontin‐ued, etc.)

• Artifact Details - includes the status of each individual artifact at the site

Chapter 1

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Users can drill into a Study Artifact Dashboard from the Country Milestones, CountrySubmissions, Site Milestones, and Site Submissions sheets. From the Study ArtifactDashboard, users can then drill into the Artifact Detail sheet.

To provide visibility into the status of a particular milestone, submission, artifact, or ac‐tivity, we also enhanced the Study Summary Dashboard to include notes recorded atthe country, site, artifact, and activity levels. Study Summary Report users can accessthe notes via tool tip links in the following worksheets:

• Country milestones

• Country submissions

• Site milestones

• Site submissions

When report users click on a country or site milestone or submission in the aboveworksheets, the worksheet refreshes to show note information related to the country orsite submission or milestone at the bottom of the worksheet. From the above work‐sheets, users can also click a country name or site name to access the All Notes work‐sheet and view all notes for the country or site milestone or submission.

Chapter 1

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Chapter 1

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2New Fields for Oracle Site Activate

With release 19.1, Oracle Site Analyze now includes the following Oracle Site Activatefields:

studies

• enable_activity_completion_publish

• enable_activity_dates_publish

• enable_artifact_events_publish

• enable_etmf_publish

• enable_milestone_publish

• enable_site_status_publish

study_level_artifacts

• external_agency_id

• document_type_name

study_level_documents

• document_type_name

study_level_submissions

• external_agency_id

• country_submission_site

• package_id

• package_submission_date

• study_site_id

• site_number

• display_status

• pi_first_name

• pi_last_name

• institution

• irb_ec_type

study_sites

• pi_credentials

study_site_release_package_documents

• review_status

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3Service Notes for Oracle Site Activate

Retired Report

With release 19.1, we retired the Oracle Site Activate Documents and Submissions re‐port. All functionality previously available in Documents and Submissions is now avail‐able in the Study Summary Dashboard standard report.

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4New Report for Oracle Site Select

Cycle Times Dashboard

With release 19.1, Oracle Site Analyze introduces a new Cycle Times Dashboard re‐port for Oracle Site Select that includes a Key Cycles summary worksheet with the fol‐lowing metrics:

1. CDA Cycle - from site CDA task available to CDA finalized

2. Select Lite Cycle - from site invitation sent to site invitation reviewed

3. Selection Cycle - from site invitation sent to site final acceptance

4. Survey Cycle - from site survey task available to site survey submitted

The worksheet displays cycle times in box and whisker plot with cycle time in days.Users can compare data by:

• All

• Region

• Country

• Study

• PI

• Workflow

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The workbook’s second sheet, “Cycle Analysis,” includes multiple filter options that al‐low users to adjust the dashboard data to their preferred views and view the data in atabular format and box and whisker plot. Report users can adjust the following filters atthe top of the worksheet:

Key Cycle Slice Data Compare Data Unit of Measure Sort Table

CDA Cycle

Select Lite Cycle

Selection Cycle

Survey Cycle

All

Region

Country

All

Region

Country

Study

PI

Workflow

Day

Week

Data Slice

No. of Cycles

Cycle Median

Report users can also adjust data included in cycle analysis using multiple filter op‐tions (e.g., Sponsor, Study Name, Region, Country, etc.) provided in the filter panel.

The Cycle Times Dashboard report also includes a Data Export worksheet that pro‐vides a downloadable version of the data used to create the cycle times metrics. Thisexport worksheet is intended for export to CSV format.

Chapter 4

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On both the Key Cycles and Cycle Analysis worksheets, users can click a cycle pointin the whisker plot diagram to access a “View Cycle Detail” link. This link then displaysthe Data Export worksheet with the data that makes up that value in the whisker plotdiagram.

Chapter 4

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5Report Enhancements for Oracle Site Se‐lect

Site Progress Report

We made significant enhancements to the Site Progress report to allow users to viewa summary of where sites are in the selection process and help them to identify barri‐ers to site progress. The enhanced report includes new and updated worksheets, aswell as improved filter and drill-down options.

The enhanced Site Progress report includes the following worksheets:

Site Progress KPI - This worksheet replaces the previous “Site progress report” work‐sheet, and we designed this new sheet to provide a highly interactive view of summaryKey Performance Indicator (KPI) data. Site progress KPI metrics represented on thisworksheet are:

• Invited to Participate

• Accessed Select LITE

• CDA Downloaded

• CDA Finalized

• Interested in Study

• Completed Feasibility Survey

• Final Acceptance

Report users can dynamically control which of the above KPIs display in the work‐sheet, and they can select up to seven to display. We also included a “Slice Data By”filter on this worksheet with study, region, and country options and a “Total Count”slide that allows users to adjust the displayed range from lowest to highest value.

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CDA Progress Report - This new worksheet has the same user interface as the SiteProgress KPI worksheet. CDA progress metrics represented on this worksheet are:

• Downloaded

• Uploaded

• Pending Site Signatures

• Requires Site Resubmission

• Finalized

Chapter 5

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Survey Progress Report - This new worksheet has the same user interface as theSite Progress KPI worksheet. Survey progress metrics represented on this worksheetare:

• Not started (when the site has reached the feasibility survey workflow task)

• In Progress

• Submitted

• Resubmitted

Site Details - This new worksheet, which is intended for export to CSV, includes thefollowing data for sites:

• Study Name

• Investigator

• Country

• Institution

• Institution type

• Survey Resubmitted

• Site Status

• CDA Status

• Survey Status

• PI Phone Number

• Email

• Specialty

Chapter 5

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When a user hovers over a top KPI or a number in the country table in the Site Prog‐ress Report, CDA Progress Report, or Survey Progress Report worksheet, a tooltipdisplays with a “View Site Details” link. When clicked, the Site Details worksheet dis‐plays details for the sites that make up the number.

Site Study Interest and Exclusion Report

With this release, we redesigned and retitled the former Site study Interest report. Nowtitled, “Site Study Interest and Exclusion,” this report provides the following sheets:

Site Invitation Responses - We redesigned this worksheet to provide report usersmore details about invitation response metrics and site disinterest reasons. Thesheet’s site interest bar graphs allow users to quickly see the distribution of site invita‐tions by status (e.g., No response, Not interested, and Interested). The worksheet alsoprovides a bar graph to visualize the number of site disinterest reason instances (e.g.,Competing trial, Complex protocol, etc.).

Report users can also adjust a wide range of filters to refine the worksheet to a prefer‐red data view. In the lower portion of the worksheet, users can also drill to investiga‐tors and site details.

Chapter 5

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Reasons for Site Exclusion - This new worksheet provides site exclusion data in asimilar format to the site invitation responses worksheet. The sheet’s exclusion bargraphs allow users to quickly see the distribution of excluded sites by bucket status(e.g., Declined, Do Not Invite, Final Decline, and Not Interested). The worksheet alsoprovides a bar graph to visualize the number of reason instances (e.g., Not enoughpersonnel, Regulatory history, Does not have adequate facilities, etc.).

Study Level Notes Report

To provide report users with improved control over data displayed, we updated theStudy Level Notes worksheet with additional filters. Users can now specify “Bucket”(e.g., Evaluate, Select, Finalize, etc.) and “Bucket State” (e.g., Back up, Declined, Fi‐nal Acceptance).

We also updated styling of the Study Level Notes report to align with other Oracle SiteSelect reports.

Chapter 5

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Survey Response Analysis Report

We modified the Survey Response Analysis report’s count logic to count one surveyresponse per Principal Investigator per study. This change ensures that metrics arenot inflated for sites that resubmit surveys.

Chapter 5

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6Data Export Utility for Oracle Site Select

With the 19.1 release, Oracle Site Analyze introduces a new self-service Data ExportUtility feature for Oracle Site Select. This feature is designed to allow permissionedusers to easily export selected data columns with custom filters to CSV.

Oracle Site Select users who have at least one role with a new permission, “Data Ex‐port Management” access the new export feature from the Oracle Site Select Dash‐boards menu. A new Data Export Utility page lists all previously-created reports, and“Edit” and “New report” actions allow users to edit previous reports or create new re‐ports based on:

• Cube (a multi-dimensional array of data) - With the 19.1 release of this feature, theavailable data cube includes site feasibility and survey response details

• Columns (dimensions) - For example: PI Name, PI email address, Country,Study, etc. Columns can be added in any order.

• Filters - For example: Study name, Country, etc. Filters can be added in any or‐der.

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7Service Notes for Oracle Site Select

Retired Report

With release 19.1, we retired the Oracle Site Select Days to Complete Survey report.All functionality previously available in Days to Complete Survey is now available inthe Cycle Times Dashboard report.

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8Stability Improvements

• Infrastructure

• Oracle Site Select Oracle Site Analyze Reports

Infrastructure

Description Ticket Priority

We made a database correc‐tion to address a duplicate keyviolation that resulted in an er‐ror.

RPT-2336 normal

We made a database correc‐tion to address an issue thatprevented creation of a uniqueindex on: index_pe_study_lev‐el_contract_dependency_con‐versionon

RPT-2183 normal

Oracle Site Select Oracle Site Analyze Reports

Description Ticket Priority

The Site Progress report in‐cluded inconsistent Final Ac‐ceptance totals when the userfiltered the report by “All”countries in the study.

RPT-2306 normal

The Study Level Notes reportdate filter incorrectly defaultedend date to November 1, 2018instead of the latest date ofavailable notes in Oracle SiteSelect.

RPT-2349 normal

The Survey Analysis reportSurvey Analysis tab displayedincorrect Question/Responsecounts for some questions.

RPT-2350 normal

For surveys created with Sur‐veyGizmo, numeric questiontypes were not included as ex‐pected in the Survey responseanalysis dashboard.

SEL-6228 normal

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9Priority Definitions

Priority Description

1 urgent (blocker) Catastrophic interruptions that result in serviceunavailability (outage). Issues may include ap‐plication unavailable errors, or critical data orservices being offline, for which there are noidentified workarounds.

2 high (critical) Major application issues that interrupt normaland expected behavior of one or more mod‐ules or business critical features of the appli‐cation, but have manual or process-drivenworkaround.

3 normal (important) Does not prevent operation of the application.Issues could include incorrect behavior of theapplication or performance issues.

4 low (minor) Occurs in the field with no impact to productionsystems. These are generally questions relat‐ing to availability of training or help content.

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10Technical Information

• Browser SupportOur goal is to provide customers with the best experience and advanced capabili‐ties, while maintaining maximum security. As products are enhanced, older brows‐ers may no longer provide the capabilities required to support these key objec‐tives. Below are current supported browsers.

• Support Transition Notice

Browser SupportOur goal is to provide customers with the best experience and advanced capabilities,while maintaining maximum security. As products are enhanced, older browsers mayno longer provide the capabilities required to support these key objectives. Below arecurrent supported browsers.

Supported browsers

Supported browsers undergo focused testing on commonly-used pages. We also ad‐dress all browser related critical and blocker issues that originate in our applications.

Product Release Supported

Oracle Site Analyze Current Chrome and IE 11

Note:

If you experience issues with a certified browser, please submit a troubleticket or call Oracle Support at 1.877.230.4168 and provide the following in‐formation:

• The browser version

• A description of your computer's basic environment

• A description of what you were trying to do and the results

Support Transition NoticeEffective April 29, 2019, support for Oracle Site Analyze will transition to the OracleHealth Sciences Support portal and will no longer be provided through the goBaltoHelp Center or through support@goBalto.com. The goBalto support phone number(877.230.4168) will continue to be available and will not change.

Oracle Site Analyze product documentation will continue to be available in the goBaltoHelp Center until further notice.

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As we progress through the integration of goBalto Support tools and processes, wewill provide advance notification to you about the changes. You can also check thestatus of the integration on the goBalto Support acquisition page.

Chapter 10Support Transition Notice

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