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Oracle® Health Sciences Site ActivateCloud ServiceRelease Notes

Release 20.1F29577-06August 2020

Oracle Health Sciences Site Activate Cloud Service Release Notes, Release 20.1

F29577-06

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Contents

Preface

Documentation accessibility vi

Related resources vi

Access to Oracle Support vi

1 Release 20.1.0.3 (available for this release 26Aug2020)

Stability Improvements 1-1

Alerts 1-1

Oracle Site Activate LITE 1-1

Smart Site Library 1-2

New Known Issues 1-2

CRO/Sponsor Collaboration 1-2

IP Release 1-2

2 Release 20.1.0.2 (available for this release 28Jul2020)


Document Management 2-1

IP Release 2-2

Notes 2-2

Study Library 2-3

Team Member Assignments 2-3

Workflow Wizard 2-3

New Known Issue 2-3

Global Search 2-4

3 Release 20.1.0.1 (available for this release 26Jun2020)

What's New 3-1

Infrastructure 3-1

iii

4 Release 20.1

What's New 4-1

API Integration 4-1

API Enhancements and Updates 4-2

IRB Integration 4-3

Event Messages 4-6


Milestones 4-7

Site Engagement 4-13


Study Library 4-17


Other Enhancements 4-20

Service Notes 4-22


API Integration 4-23

Bulk Work 4-24

Contracts 4-25

Corrections 4-25


Global Search 4-26

IP Release 4-26

Milestones 4-26

Reports 4-27

Site Experience 4-27


Study Country 4-28

Study Site 4-28

Submissions 4-28

User Interface 4-28

New Known Issues 4-28


Bulk Work 4-29

Contracts 4-30

Milestones 4-30

Study Library 4-30

Submissions 4-31

Workflow Wizard 4-31

Previously Reported Known Issues 4-31

Activities 4-32

iv


Contracts 4-32

CRO/Sponsor Collaboration 4-33

Data Export Utility 4-34


Electronic Signature 4-34

Global Search 4-35

IP Release 4-35

Milestones 4-36

Single Sign On (SSO) 4-36

Site Experience 4-36


Staff Documents 4-37

Study Library 4-38

Submissions 4-38


User Interface 4-39

Deprecated Known Issues 4-40


5 Severity Definitions

6 Browser Support

7 Impact Analysis

8 Revision History

v

Preface

This preface contains the following sections:

• Documentation accessibility

• Related resources

• Access to Oracle Support

Documentation accessibilityFor information about Oracle's commitment to accessibility, visit theOracle Accessibility Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.

Related resourcesProduct documentation and other supporting materials are available on the OracleHelp Center.

Access to Oracle SupportOracle customers that have purchased support have access to electronic supportthrough Support Cloud.

Contact our Oracle Customer Support Services team by logging requests in one of thefollowing locations:

• English interface of Oracle Health Sciences Customer Support Portal (https://hsgbu.custhelp.com/)

• Japanese interface of Oracle Health Sciences Customer Support Portal (https://hsgbu-jp.custhelp.com/)

You can also call our 24x7 help desk. For information, visit http://www.oracle.com/us/support/contact/health-sciences-cloud-support/index.html or visithttp://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are hearing impaired.

Preface

vi

http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc

http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc

https://docs.oracle.com/en/industries/health-sciences/site-activate/index.html

https://docs.oracle.com/en/industries/health-sciences/site-activate/index.html

https://hsgbu.custhelp.com/

https://hsgbu.custhelp.com/

https://hsgbu-jp.custhelp.com/

https://hsgbu-jp.custhelp.com/

http://www.oracle.com/us/support/contact/health-sciences-cloud-support/index.html

http://www.oracle.com/us/support/contact/health-sciences-cloud-support/index.html

http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs

1Release 20.1.0.3 (available for this release26Aug2020)

This section describes the content of the 20.1.0.3 hotfix release.

• Stability ImprovementsThis section describes issues fixed in this hotfix release.

• New Known IssuesThis section identifies new issues found during development of this hotfix release.

Stability ImprovementsThis section describes issues fixed in this hotfix release.

• Alerts

• Oracle Site Activate LITE

• Smart Site Library

Alerts

Description Ticket Severity

Some users received newstudy activity alerts even whenthe users were not assigned tothe studies.

CHK-32250 2

Oracle Site Activate LITE


User name, account name,study name, and activitiesdid not display as expectedfor users who accessedOracle Site Activate LITE withInternet Explorer 11.

CHK-32251 2

1-1

Smart Site Library


When selecting multipledocuments in the library, userswere unable to select thewet ink option for individualdocuments.

CHK-32253 2

New Known IssuesThis section identifies new issues found during development of this hotfix release.

• CRO/Sponsor Collaboration

• IP Release

CRO/Sponsor Collaboration


On the Account Overviewpage, the default Sort optionof "Prioritized Site" does notdisplay as the selected optionand activities are not sorted byPrioritized Sites as expected.

CHK-32382 3

IP Release


A user who does not havea role that allows Define IPPackage activity can modifyUrgent/Not urgent, Localapproval, and Submission toFDA fields, but the Savebutton remains disabled andthe fields are not updated.

CHK-32385 4

Chapter 1New Known Issues

1-2

2Release 20.1.0.2 (available for this release28Jul2020)

This section describes the content of the 20.1.0.2 hotfix release.

• Stability ImprovementsThis section identifies issues fixed in this hotfix release.

• New Known IssueThis section identifies an issue found during development of this hotfix release.

Stability ImprovementsThis section identifies issues fixed in this hotfix release.

• Document Management

• IP Release

• Notes

• Study Library

• Team Member Assignments

• Workflow Wizard

Document Management


An error occurred when usersattempted to enter a date witha year prior to 2000. Thisfix ensures that users cansuccessfully enter and savedates that include a four-digityear value between 1000 and9999.

CHK-30750 2

Users were unable tosuccessfully upload countrylevel documents for a studythat included France and sitesassociated to France.

CHK-31127 2

2-1


Users may have experiencedmissing values in thedocument Type list. Wecorrected this issue and allitems that had document Typevalues with the same namebut different IDs now have adocument Type of a singleID and the same name, asdesigned.

CHK-31177 2

IP Release


In the IP Release placeholdermetadata section, the "Save"button did not show as activeafter a user modified one ofthe fields; however, the buttonwas active and successfullysaved any changes tometadata fields.

CHK-30766 3

Notes


If a user shared a note to"All" site users, the note wasnot shared to all subsequentusers added after the notewas shared.

CHK-30729 3

When a user edited anote in the item placeholderand saved, and the notehad a Type, Summary,and/or enabled "Share toall site users" value, thenote successfully savedbut the Type, Summary,and/or sharing attributes wereerroneously removed.

CHK-31257 2

Chapter 2Stability Improvements

2-2

Study Library


When a site was in "Dropped"status and documents wereshared at the country level,site level lineage items werenot created and availablewhen the site was later movedto "In activation" status.

CHK-31420 3

Team Member Assignments


When a site number includeda dash character, userswere unable to assign teammembers to the site.

CHK-29920 3

Workflow Wizard


When using the workflowwizard to bulk generate itemsacross multiple sites, if one ofthe sites already had the itembeing generated, the duplicate

item icon ( ) displayed forthat item. When a user clickedthe icon, to deselect the siteso it would not receive theduplicate item, resulted in anerror and not all expecteditems were generated.

CHK-29959 2

New Known IssueThis section identifies an issue found during development of this hotfix release.

• Global Search

Chapter 2New Known Issue

2-3

Global Search


Search results mayerroneously include studies towhich the user has not beengranted access. When thisoccurs, and the user clicks anon-permissioned study in theresult list, an error messagedisplays and the user is notable to access the study.

CHK-31703 4

Chapter 2New Known Issue

2-4

3Release 20.1.0.1 (available for this release26Jun2020)

This section describes the content of the 20.1.0.1 hotfix release

• What's NewThis section details improved functionality with this hotfix release.

What's NewThis section details improved functionality with this hotfix release.

• Infrastructure

InfrastructureIn this hotfix, we made infrastructure improvements to ensure that the 20.1 releaseversion is compatible with Oracle Cloud Infrastructure.

3-1

4Release 20.1

This section describes the content of the 20.1 major release.

• What's NewThis section details new and enhanced functionality with this release.

• Service NotesThis section provides advance notice of upcoming service changes.

• Stability ImprovementsThis section identifies issues fixed in this release.

• New Known IssuesThis section identifies issues found during development of this release.

• Previously Reported Known IssuesThis section identifies issues reported prior to this current release.

• Deprecated Known IssuesIssues in this section are no longer applicable (e.g., does not occur, will not beprioritized for fix, working as designed, and/or does not affect current functionality).We removed the item from the known issues list.

What's NewThis section details new and enhanced functionality with this release.

• API Integration


• Milestones

• Site Engagement


• Study Library


• Other Enhancements

API Integration• API Enhancements and Updates

• IRB Integration

• Event Messages

4-1

API Enhancements and Updates

Submission Reason field

We updated the Artifact PUBLISH API to now include the submission_reason (string)field in submission event messages even when the submission has not yet beencompleted. The publish message includes the submission reason when the data ispresent in a submission at the country or site level.

Submission risk and risk reason

The Activity Dates PUBLISH API now includes submission_at_risk (Boolean) andsubmission_at_risk_reason (string) fields. When the submission_at_risk Booleanvalue is true, submission_at_risk_reason will be populated in the publish message, asrisk reason is a required field in the Oracle Site Activate user interface.

PI name and city

The Study Sites GET response now returns more data for Principal Investigators. Weupdated the API to now include principal_investigator, city, and match_type fields.The principal_investigator object includes: first_name, last_name, credentials,and pi_designation. All new fields are string (text) type.

Deprecated field

With release 20.1, we also deprecated the Study Sites GET People field. This field willbe removed from the GET response in release 20.3.

Support <closed> parameter

Study Site POST and Study Site PUT APIs now accept closed (string) status whencreating or updating a study site.

CRO/Sponsor name field and query parameter

We updated User GET API responses to now include the cro_sponsor_name (string)field, and the API now supports cro_sponsor_name as a query parameter as well.When the parameter and a CRO/Sponsor name are sent in the GET call (e.g.,"cro_sponsor_name" : "ExampleCRO1"), the API responses include only those userswith that specified, valid CRO/Sponsor value.

Create Box storage folder

For Box-enabled accounts, creation of new studies, countries, and sites via StudiesPOST, Study Countries POST, and/or Study Sites POST APIs now automaticallytriggers creation of a Box storage folder.

Translation type

With this release, Oracle Site Activate can now capture whether a document languageis the "original" (default) or "translated" version. When this feature is enabled forthe account, and when “Enable artifact language” is enabled for the item, a new“Translation type” field is available in Oracle Site Activate, in the item’s TMF section.

When this feature is enabled, translation_type (string) will also be added to eTMF andArtifact PUBLISH messages and Artifact GET response messages.

Chapter 4What's New

4-2

Year validation

PUT APIs that accept dates did not previously validate that a date's year format wasas expected (exactly 4 digits and a value less than "3000"). To ensure data quality,with release 20.1, we enhanced validation for baseline, planned, and actual milestonedates as well as activity completed dates to ensure that only properly formatted datesare accepted.

IRB Integration

Filter IRB documents

Oracle Site Activate users who manage received IRB documents can now filter the listof documents in the Quarantined files area, on the IRB documents tab. Users can filterlist by file name, site, country, study, or source. Filtering is not case sensitive.

Match file to an item flow

We enhanced the “Match file to an item” modal to improve the user interface and helpusers understand when to match an inbound file to a placeholder with multiple openactivities.

Modal enhancements include:

• The file’s TMF identifier now displays below the file name at the top of the modal

• Expanded horizontal display removes the horizontal scroll bar when possible

• Wrapped text now properly aligns with previous line’s text

The modal now also displays an artifact status icon in line with each placeholder item.The status indicators are intended to help users understand that a document hasalready been added to certain placeholder and perhaps the placeholder should not beused again.

Chapter 4What's New

4-3

Add new item flow

With release 20.1, we made two enhancements to the "Add a new item" flow:

1. When adding a protocol related document, the Protocol drop-down list nowincludes all protocol labels saved for the study.

2. Using a new "Share with sites" option, users can now share the documentimmediately with selected or all site users when site sharing has been enabledfor the item.

TMF identifier requirements

Previously, an IRB file sent in to Oracle Site Activate via the IRB File POST APIneeded to have a TMF identifier on the item that had already been deployed atleast once at the study or site level. We updated this logic to remove the previousdeployment requirement. Now an inbound IRB file with a TMF identifier that exists inthe study configuration at the appropriate country or site level will process successfullywithout requiring previous deployment.

Chapter 4What's New

4-4

New validation API

A new IRB Parameter Validation API allows IRB partner users to now validate ifa study and site pair exist in Oracle Site Activate. The POST call, which uses thecustomer’s IRB token for validation, accepts study and site identifiers supported by theIRB File API:

• Study identifiers (string): cros_study_id, protocol_number, study_name

• Study Site identifiers (string): cros_site_id, pi_name, site_number

The POST call must include at least one field from the study identifier category andone field from the study site identifier category. When the study and site exists inOracle Site Activate, the API returns confirmation that includes the identifiers sent inthe request body as well as the site_number. When the study or site does not exist inOracle Site Activate, the API response is a relevant error message.

Upload to blocked item

Previously, blocked items did not allow users to upload an IRB file from the matchingqueue. With this release, we enhanced IRB file matching logic to now allow users tomatch the item and upload the file without regard to the item’s blocked or availablestatus.

When the item is unblocked (missing approval obtained, next required task completed,etc.), the matched file is available on the item in the “File history” section andthe “Related Activities” section includes the upload with the name of the user whosuccessfully matched and uploaded the file and the text “via IRB Workflow.”

Chapter 4What's New

4-5

Event MessagesA new “Endpoint” filter on the Event Messages page allows users to specify apublishing endpoint and filter the message list to only those that include that endpointidentifier. When no endpoint has been specified, the filter default is “All,” which returnsmessages for all publishing endpoints.

We also relabeled the "Show" filter to "Status," and we added "Processing" as anavailable filter in the drop-down menu.

Chapter 4What's New

4-6

Document ManagementTo enable more discrete document mapping, we'll add two new, optional fields thatwill be available when users create or edit an item. The fields, "TMF sub type" and"TMF Sub sub type," can be enabled in Configuration Designer by users who have theappropriate permissions to modify items in these areas.

MilestonesSuggested milestone dates

With this release, Oracle Site Activate introduces milestone prediction functionality.Users who plan or replan a site level milestone mapped to the global milestone IPrelease ready can now improve planning accuracy by using a suggested milestonedate. This option is available whenever a suggested date is available and in all OracleSite Activate areas where users can plan or replan site milestones:

• Site milestone timeline

• Site milestone dashboard

• Bulk milestone planning

When a user plans or replans an individual site IP release ready milestone and asuggested date is available, a new checkbox option displays at the top of the planningmodal. The checkbox option identifies the suggested planning date in bold text. Whena user clicks the checkbox, a suggested date applied icon ( ) displays inthe modal. To align with previous functionality, when users replan a milestone using asuggested date, they are required to specify a reason for replanning.

Chapter 4What's New

4-7

On the Study Planning page, we also added a new “Suggested” date column. Userscan quickly identify items available for individual or bulk planning with suggesteddates:

• When a suggested date is available but has not yet been applied, the datedisplays in the Suggested column

• When a milestone has already had the suggested date applied, a new applied icon( ) displays in the column

When bulk planning site milestones, users will toggle to “Suggested dates” and clickthe checkbox for “Apply suggested dates.” If a user selects a site milestone to includein bulk planning with suggested dates, but that milestone does not have a suggesteddate (i.e., no date available, not a supported milestone for prediction, etc.), Oracle Site

Chapter 4What's New

4-8

Activate will simply take no action on that milestone and it will remain as it was beforeselection.

Study Milestones

With release 20.1, Oracle Site Activate introduces the ability for users to managestudy-level milestones in order to plan for the finalization of study files like protocols,ICFs, and others. This new functionality includes multiple enhancements:

Study home page

The study home page now features four primary tabs:

1. Study work – This new tab provides a study level milestone timeline.

2. Dashboard – This tab displays the previously-available country milestonedashboard.

3. Country progress – This tab, previously labeled “Documents,” includes the barchart of document progress by country.

4. Notes – This tab displays the previously-available study level notes view.

We also updated Display settings, and users can choose any of the above tabs astheir default study view.

Planning and Corrections

In addition to managing study level milestones on the timeline via the new “Studywork” tab, users can also plan these milestones, individually and in bulk, from thestudy home page Planning, Milestones tab. They are also available for corrections inthe Corrections, Milestone tab.

Chapter 4What's New

4-9

To help users quickly locate milestone items, we added a new "Show" filter that allowsusers to select from All, Study, Country, or Site. From the study home page, the filter isavailable as follows:

• Planning tab – Milestones sub-tab

• Corrections tab – Activities, Milestones, and Items sub tabs

Milestone notes

With release 20.1, Oracle Site Activate introduces the ability for users to add notes tomilestones and submission milestones. Users can add notes as follows:

• Milestones

– Milestone dashboard (country and site)

– Milestone timeline (country and site)

– Study home page Planning tab, Milestones sub-tab

Submissions:

– Milestone dashboard (country and site) – if the submission was added to themilestone calendar

– Milestone timeline (country and site) – if the submission was added to themilestone calendar

– Submission timeline (country and site)

– Study home page Planning tab, Submissions sub-tab

When viewing a milestone from a dashboard or timeline listed above, the note optiondisplays as a hyperlinked icon ( ) accompanied by a note count. If notes exist forthe milestone, when a user hovers over the note icon, the name of the last person whoentered a note displays.

When the user clicks ( ) the note modal opens to display the milestone's entirenote history. When no previous milestone notes exist for display, the user can add a

Chapter 4What's New

4-10

new milestone note of up to 3,000 characters. Notes also allow users to specify Typeand Highlight when appropriate.

On the Study home page Planning tab, Milestones and Submissions sub-tabs, userscan now click note ( ) in the Actions column to add or review milestone notes. Whenusers click edit ( ) in the Actions column, the planning modal now includes the abilityto add milestone notes as well.

Milestone date change

We also made it easier for Activate users to know when a milestone date has been

replanned. The new hyperlinked icon ( ) displays on:

• Study level milestone timeline

• Country milestone timeline

• Country milestone dashboard (when a user hovers over a milestone)

• Site milestone timeline

• Site milestone dashboard (when a user hovers over a milestone)

Chapter 4What's New

4-11

Users can click the icon to view details of the replanning (i.e., user who replanned themilestone, replanning time stamp, and reason for change).

Milestones marked at risk

We updated milestone at risk hover over tool tips on the country and site milestonedashboards to now display Risk reason(s). We also updated the hover over tool tip textfrom "This milestone is at risk of being completed on time." to "This milestone is at riskof not being completed on time." The updated text displays in the following areas:

• Milestone dashboard (country and site)

• Milestone/submission calendar

• study planning- milestones and submissions

We also updated logic related to At risk setting retention. Previously, milestones andsubmission milestones marked "At risk" retained this setting even after completion.With this release, we enhanced this logic. Now, when milestones and submissionmilestones are completed, they automatically have At risk ( ) removed in the userinterface.

Note:

The milestone will also no longer be marked as at risk in the Oracle SiteActivate database. However, the fact that the milestone was marked at riskand the duration that it was marked at risk remain reportable.

Chapter 4What's New

4-12

Site milestone dashboard

Now users can specify the site milestone dashboard as their country home pagedefault view, if preferred. We added a new Display Settings control where users canspecify either "Country work" (Country tab) or "Site dashboard" (Dashboard tab) astheir default view. The control works in the same way the Display Settings controlworks on the study home page view - once set, the specified view displays each timethe user visits the page until the user changes the setting. The setting also persistsupon logout. If the user does not specify a preferred default, the default view is theCountry tab.

Site EngagementUnified site experience

With this release, Oracle Site Activate simplifies how site experience users accessmultiple accounts by allowing users to optionally link accounts under a single login.

Site experience now includes two new options at the upper right of the Oracle SiteActivate page:

1. A “View activities for other sponsors/CROs” navigation link

2. A “Link this <AccountName> account with sites page” check box

Chapter 4What's New

4-13

After a site experience user clicks the “Link this…” to link the account, and when theuser then clicks “View activities…” navigation link, a new landing page view displays.The number of accounts the user has linked displays at the upper left just above anaccount filter, and if an account-specific logo has been saved it displays to the right of"Managed by" text below the account name. The landing page also includes a graphshowing the percentage of the user's completed assigned activities.

The lower portion of the landing page is an activity grid that allows users to sort anycolumn to quickly locate activities within the account by study, institution, investigator,number of activities, and activity age. When a user clicks a "<#> activities due" link inthe "Your activities" column, the related site page in Oracle Site Activate automaticallydisplays so the user can quickly take action on the activity(ies). Users can also returnto the Oracle Site Activate from the landing page at any time by clicking the "Back toActivate" link in the header’s far right.

Site experience users can add new links or unlink accounts at any time by checking/unchecking the “Link this…” check box on the home page. However, when a userhas not checked the box for any accounts and the user clicks the "View activities"navigation link, Oracle Site Activate displays instructions so the site user can quicklyunderstand the procedure for linking accounts.

Chapter 4What's New

4-14

View only system role

We enhanced role management to now allow site experience users to be designatedas "View access" users. The Add/Edit User Account page, under Team members,Roles tab, now displays a new "Access type for Site experience" section when theselected User Type is "Site user." Site users with "View access" setting can view datain Oracle Site Activate but not update any data with the exception of their own useraccount profiles and settings.

This enhancement did not alter existing site user accounts. All site experienceuser accounts existing prior to this enhancement are automatically designated"Participatory access," meaning the users have the ability to interact with assignedactivities as they did previously.

Chapter 4What's New

4-15

Chapter 4What's New

4-16

Discontinue documents

With release 20.1, we removed "Discontinue this Version" button for site experienceusers so they no longer have the ability to discontinue documents.

Smart Site LibraryOracle Site Activate Smart Site Library no longer uses case sensitivity for letter stringmatches when determining a staff match with a previous study site. Oracle SiteActivate will recognize a match when:

1. staff is of the same type AND

2. the name is an identical letter string match

Study LibraryDrag and drop file upload

To make it easier than ever for users to upload and replace file attachments, OracleSite Activate introduces drag and drop file management in the Study Library. On theDocuments tab, users who have a business role that allows them to upload documentsto Study Library can now "drag" a file to a document’s row on the grid and "drop" it toattach it to that item.

Because each document allows one file attachment, an alert message displays if theuser attempts to drop a file on a row that has an existing attachment. An alert alsodisplays if the user attempts to drop multiple files to a document row at one time.

When the user "drops" the file on an available row, the document modal displays,and the user can specify document metadata as preferred (e.g., Document Date,Responsible Party, Description, etc.) before clicking "Done" to save the file attachment.

For rows where a file has already been added, if a user attempts to drop a new file intothe row they are alerted to instead edit ( ) to replace the file. The user can replace theexisting file by dropping a new file into the edit modal.

Chapter 4What's New

4-17

File replacement, preview, and removal

With release 20.1 we made multiple enhancements to Study Library documentmodals. When a user who has “Enable document upload, removal, and Typemanagement in Study Library" permission clicks edit ( ) in the Document tab'sActions column, the user sees the following user experience enhancements:

• "Auto-share" status is now easily visible at the upper left of the modal where theview-only toggle now displays.

• When the document has a saved file attachment, the file name is now a hyperlink.When clicked, the file downloads to the user’s browser.

• If the file type supports preview, users can click preview ( ) to the right of thefilename hyperlink to view the file in a new browser. File types supported forpreview are dependent upon the account’s configured file storage service (S3 orBox).

• Just below the hyperlinked file name, a new “Replace attachment” buttonmakes it easy for permissioned users to replace files. When clicked, afile browser displays and the user can then select a replacement fileto upload to the modal or drag and drop a replacement file into thedocument modal. Study Library replaces the file after the user specifiespreferred metadata (Document Date, Version, etc.) and clicks “Done.”

• When a document has an attached file, but the file has not yet been shared to anycountry or site, users can now click delete ( ) to the right of the hyperlinked filename. When clicked, the file attachment is removed from the user interface, andwhen the user clicks “Done,” the file is removed from the Oracle Site Activate

Chapter 4What's New

4-18

database as well.

Document Type configurable list of values

With release 20.1, we’ll enhance Study Library to replace free-text document Type witha configurable list of document Type values. This enhancement reduces confusion forusers, eliminates the possibility of typos in free-text entries, and ensures association ofaccount-preferred Type values going forward.

The "Select a type" drop-down menu contains an alphanumeric list of all documentTypes saved for the account prior to release 20.1. For example, an account that had"Doc Type A" and "Doc Type B" saved as Type values now has a "Select a type"drop-down menu that includes "Doc Type A" and "Doc Type B" values. Documentsthat had Type values saved prior to this enhancement continue to have the samevalues; this enhancement did not remove the Type associations saved prior to the 20.1release.

We also updated the "Type" filter on the documents table to order filtered documentsalphanumerically.

Study Library users who have a business role permission to edit and remove Typevalues now no longer have the ability to do so, regardless of permission label.

• In the Add a document flow, the “Select a type” field no longer provides an optionto add a new type

• The Type filter above the document grid no longer provides an “Add at type +”option

• The Document grid Actions menu no longer provides a "Remove type" option

Note:

If no document types have been saved for the account, the “Select a type”and “Add a type” options do not display. This is expected behavior. Pleasecontact your Oracle Project Manager to discuss use of the Document Typevalue feature.

Chapter 4What's New

4-19

Team Member AssignmentsCRO/Sponsor drop-down menu

On the Create/Edit User Account page, we updated the CRO/Sponsor drop-downmenu to now display the contents in alphanumeric order. This minor enhancementwill make it easier for users who create or manage user accounts to locate theorganization to which the new/edited user account should be tied.

Search results

Previously, when multiple team members were assigned to a role, only the primaryassigned member was returned in search results. We updated search functionality toensure that when an Oracle Site Activate user searches by user's name or email onthe team tab any role to which the searched user is assigned returns in the searchresults, regardless of whether the searched user is the primary assignee or not.

Other EnhancementsMicrosoft Excel .xlsm files

Oracle Site Activate now allows upload and download of Microsoft Excel Macro-Enabled Workbook (.xlsm format) spreadsheet files. Customers can now alsosuccessfully upload .xlsm format files via API calls.

Filter by favorite studies

In the Bulk Work and Team Member Assignments areas, we enhanced the filter modalto now include "Show only my favorites" at the Study level. This enhancement allowsusers to quickly include favorites as a filter criteria when available. If a user checks thebox, but no favorite countries exist, Oracle Site Activate displays the message, "Youhave no favorite studies matching these filters."

Chapter 4What's New

4-20

Branding

We made a minor branding update to the Terms of Use page. Section headings andaction buttons now display in blue instead of orange. We did not alter Terms of Uselanguage in any way.

Prioritized sites

We enhanced the persistent header to now display prioritized ( ) when viewing thesite page for a prioritized site.

Session timeout

User session timeout warnings previously reflected the default Oracle Site Activate 15minute logout threshold. We enhanced the warning message to now reflect a customtimeout value when configured for an account. Provided the custom timeout value isgreater than 5 minutes, Oracle Site Activate now includes the custom value in themessage and displays the message 2 minutes prior to automatic logout.

Chapter 4What's New

4-21

Year validation

We updated year validation with this release. Now, if a user attempts to manually entera year value that is greater than four digits long, the date will be rejected with the errormessage, "Please enter a valid date."

Service NotesThis section provides advance notice of upcoming service changes.

Reports

In the upcoming 20.2 release, Critical Path Reports in Oracle Site Activate will be fullydecommissioned. The content of the Critical Path Reports has been replaced in recentreleases by Oracle Site Analyze standard reports (e.g., Study Summary Dashboard).Please contact your Oracle Application Lead if you have any questions.

Enabled Features

In the upcoming 20.3 release, we will remove Oracle Site Activate controls that enable/disable features at the customer account level. The effect of this removal is that thefollowing features will be enabled for all accounts:

• Enable adhoc documents

• Enable site status of 'Closed'

• Enable milestone planning in submission activities tab

• Enable document expiry management

• Enable the display of institution name on Country and Site Detail pages

• Enable site library

• Enable submission type collection

• Enable submission category collection

• Enable multiple principal investigators (allows replacement of PI functionality)

• Enable contract management

• Enable contract type collection

• Enable self serve corrections (allows users who have correction permissions tocorrect activity completion dates)

• Enable new bulk page access (Replaces the Bulk work area on study home pagewith the new Bulk work area accessed via global navigation)

• Enable document date

• Enable site documents in country IP review planning (allows users to choose sitelevel documents when planning country level IP reviews)

Stability ImprovementsThis section identifies issues fixed in this release.

• API Integration

Chapter 4Service Notes

4-22

• Bulk Work

• Contracts

• Corrections


• Global Search

• IP Release

• Milestones

• Reports

• Site Experience


• Study Country

• Study Site

• Submissions

• User Interface

API Integration


The Artifact PUBLISHupdated_at field did notupdate as expected when anartifact's activity dates wereupdated. The field updated ifanother activity was completedbut not if a completed activitywas updated. Additionally, anactivity completion messagewas not transmitted asexpected if an activity datewas changed. We correctedthese issues and updated theAPI behavior as follows:

Updating the completed datefor an activity now triggers anactivity completion messagewith new date, and when theartifact is completed, triggersan artifact API messagewith an updated_at date.If updating the completeddate for an activity, and thatactivity is the artifact's last(i.e., completing) activity, theapproval_date on the artifactwill also be updated.

CHK-27822 2


4-23


Study Country POSTmessages failed when sentwith no country status,although country status wasnot required. We corrected thisissue so that country statusnow defaults to "In activation"if no explicit value is receivedin the message.

CHK-28243 1

In Activities PUT, validparameter tmf_identifier_v2was not recognized andresulted in an "Unable toprocess the request. Pleaseensure the request wasformatted correctly." error.

CHK-28565 2

We made infrastructureimprovements to ensure thatfiles in Box storage enabledaccounts can be successfullyretrieved regardless ofprocessing or retry date.

CHK-28730 2

eTMF PUBLISH messageswithout files failed even when"hasFileContent" was set tofalse. We corrected thisissue so that artifacts withoutfiles attached can still besent via eTMF PUBLISH. If"hasFileContent" = true (i.e,a file should be present) andno file URL is present, themessage will still fail.

CHK-28811 3

Intermittently, the Artifact GETAPI may not have pulled themost recent document whenmultiple versions exist. Thisfix ensures the most recentversion is always sent.

CHK-29071 2

Bulk Work


If a user entered a Version IDof 25 or more characters andclicked Done or Update, theVersion ID was not updated asexpected.

CHK-22872 3

Item descriptions did notdisplay as expected whenusers hovered over an itemname.

CHK-28113 3


4-24

Contracts


When a very high numberof studies (i.e., 1,000+) werecreated at one time viaAPI, not all contract andbudget items were created asexpected.

CHK-29186 2

Corrections


When a user had thebusiness permission "Enabledata change users with thisrole to correct metadata" butdid not also have the "Enabledata change users with thisrole to correct attachments,"permission, the user did nothave access to the Edit (pencilicon) action on the Correctionstab.

CHK-29707 3

Document Management


When users attempted toexport completed documentsusing the option in the Actionsmenu, the export was notsuccessful for countries andsites that had many completeddocuments.

CHK-28132 2

When several files existedunder a placeholder's Previousfiles section, the preview(magnifying glass) icon for apreview-supported file type didnot display as designed.

CHK-28121 4

The Quarantined files pagetook a very long time to loadall available documents. Toaddress this issue, we addedpagination to the page, andusers can now advance orreverse through up to 15 filesper page.

CHK-28123 3


4-25


In Bulk Work, when usersdiscontinued a document, theReason drop-down menu's"Other" free text fieldsupported up to 25 charactersof free text when it shouldhave supported up to 100characters of free text.

CHK-28325 3

Text search for Site documentson the Quarantined files pagewas not responsive.

CHK-29081 2

When a document belongingto a specific staff member andhaving and expiration date setpast 90 days was upversioned,the same document (that wasnot upversioned for otherstaff members) incorrectlydisplayed a gray clock icon.

CHK-29106 2

Global Search


When the matching recordswere identified using theglobal search option, thenumber of matches displayed,but the corresponding recordsdid not.

CHK-29070 3

IP Release


Characters that werenot supported in theWindows-1252 character setprevented a user fromapproving an IP Reviewpackage.

CHK-29164 3

Milestones


Reason for change shouldhave been a required fieldwhen correcting a milestonecompleted date.

CHK-28629 3


4-26


Smart submission milestonesdid not indicate "Initial submit"or "Final approval" whenplanning on the dashboard.

CHK-28404 3

When both submission dateswere planned, "at risk" flagsset on individual submissiondates could affect otherassociated dates (e.g., Finalapproval and Initial Submitsubmission dates).

CHK-28810 3

Reports


When a user entered validStudy and Timeline values tocreate an Audit Trail report, thereport was not generated.

CHK-29092 1

Site Experience


When configured for anaccount, a customer's logowas not displayed in emailalert notifications to site users,even when activity completionby email was disabled.

CHK-27912 3

Smart Site Library


We made infrastructureimprovements to ensure thatSmart Site Library identifiesavailable site matches asdesigned.

CHK-28135 1

Sites with matching PI firstname, last name, institutionname, and city were notmatched as expected.

CHK-28941 2


4-27

Study Country


For Belgium only, an errormessage displayed whenusers attempted to setthe country status to "Inactivation," and the changedstatus was not saved.

CHK-28941 3

Study Site


When attempting to uploaditems for one study site, theanimated virus scan graphicran continuously and fileupload was unsuccessful.

CHK-29058 3

Submissions


When the redesigned site andcountry page user interfacefeature (introduced in release19.4) was enabled for anaccount, submission Type andCategory fields did not displayin the item's "SubmissionInformation" section.

CHK-27913 3

On the Submission detailspage, the "Change level"selector did not functionas designed to save theselected level and display thesubmission grid.

CHK-29082 1

User Interface


Text size for item names inthe IRB "Match file to an item"modal was smaller than othertext in the modal.

CHK-29706 4

New Known IssuesThis section identifies issues found during development of this release.


4-28

• API Integration

• Bulk Work

• Contracts

• Milestones

• Study Library

• Submissions

• Workflow Wizard

API Integration


In event messages, thesubmission_reason fieldtransmits an invalid emptystring even when it should beNULL.

CHK-29678 3

Date values in the MilestonesPUT API do not accept datesin ISO_8601 standard format(yyyymmdd).

CHK-29812 3

In Milestone PUT, time valuesare accepted although theyare not stored. Milestone GETresponses and the Oracle SiteActivate user interface willdisplay only date values.

CHK-29850 3

Bulk Work


Attaching a file toapproximately 100 activities/items at one time results inerror.

Workaround: Perform thiswork in smaller batches of nolarger than 20 activities/itemsat one time.

CHK-29899 3

When a user enables the"Show only my favorites" filterat the study level, the filtersetting erroneously applies tothe Country level, even whenthe Country level favoritescheck box is not checked.

Workaround: Toggle thefavorite check box off beforeproceeding to the next step inthe filter modal.

CHK-31155 3


4-29

Contracts


For discontinued contract andbudget items, metadata andcontract information fieldsremain enabled when theyshould be disabled.

CHK-29912 3

Milestones


When planning a study levelmilestone that does not yethave a configured item tocomplete, users are promptedto "Add country documents/submissions to generate itemsfor this milestone."

CHK-29815 3

When a user clicksPlanned date changed

( ), themilestone planning modalopens and blocks the reasonfor replanning modal.

Workaround: Click "X" toclose the planning modal.

CHK-30426 3

Study Library


When a user unsuccessfullyattempts to remove adocument (e.g., the documenthas already been shared andmay not be removed), and theuser then dismisses the errormessage, document grids onthe Document and Share tabsdo not display documents.

Workaround: Refresh thepage.

CHK-29944 4


4-30

Submissions


For sites that have a PrincipalInvestigator replacement, nonew submission package isgenerated when a user clicks"Add a new sub-committee."

CHK-29295 3

Workflow Wizard


In the "Selected" pane,the item count improperlyupdates when a document isdeselected.

CHK-29885 4

Previously Reported Known IssuesThis section identifies issues reported prior to this current release.

• Activities

• API Integration

• Contracts

• CRO/Sponsor Collaboration

• Data Export Utility


• Electronic Signature

• Global Search

• IP Release

• Milestones

• Single Sign On (SSO)

• Site Experience


• Staff Documents

• Study Library

• Submissions


• User Interface

Chapter 4Previously Reported Known Issues

4-31

Activities


The paperclip icon indicatingan attachment does notdisplay as expected in thepackage header.

CHK-16128 4

API Integration


When a site's status changesvia study_sites PUT, thatchange is not published viasite_status POST. Updates tosite status via the UI arepublished in the API.

CHK-7378 3

When identifying a site,principal_investigator PUTcalls should validate theuniqueness of cros_pi_id andsponsors_pi_id fields, anddoes not return an error ifthe call specifies a preexistingvalue for either field.

CHK-20128 3

The accept header in POSTAPI calls sends "accept":"json"but this header should be"accept":"application/json".

CHK-24210 4

The Study Site API (POSTor PUT) allows creationor update of a site witha duplicate cros_site_id orsponsors_site_id value.

CHK-27914 3

Contracts


When a completed date for anactivity is deleted, it cannot bereset.


CHK-23691 3

If contract activities areblocked by budget andcontract language activities,and the activities arecompleted, the “view blockingitems” link displays until thepage is refreshed.

CHK-18192 3


4-32


When editing a completedbudget to replace the currencyvalue, the new value does notdisplay after clicking Done inthe edit modal.


CHK-20273 4

Creating a new budget versionon a contract item successfullyadds a new version, butthe new version does notinclude a revision number asexpected.

CHK-20631 3

When editing a contractbudget currency value, theupdated value is not displayedin the widget until the userrefreshes the page.

CHK-23461 3

Search results incorrectlyreturn all amendments tiedto a contract, even when allamendments returned do notmatch the search criteria.

CHK-27770 3

CRO/Sponsor Collaboration


The business partner orsite assignments icon hasinconsistent display logic forsubmission packages.

CHK-20086 3

The hover-over tool tipshowing an activity is assignedto an external user displaysonly one name when the role“Country Lead” is assignedto two external users fromdifferent accounts.

CHK-23407 3

On the Account Overviewpage, for contract andsubcontracts, the word“Actual” is misaligned in theitem heading.

CHK-23409 4


4-33

Data Export Utility


Export preview displaystimestamps in the browser'stimezone instead of inCoordinated Universal Time(UTC) like other Oracle SiteActivate and Oracle SiteAnalyze reports.

CHK-24689 3

Document Management


When file upload fails dueto configuration or a detectedvirus, the file upload processfails, however the documentstatus is still updated.

CHK-2898 3

No alert message is generatedwhen a duplicate Country adhoc protocol-related documentis created.

CHK-8844 3

Electronic Signature


If a user is tagged toelectronically sign a contracttype document, but the useris not assigned to a businessrole with access to contracts,the user can’t open thealert in Oracle Site Activateto complete the electronicsignature process.

Workaround: User canaccess the contract documentvia a link in the emailnotification.

CHK-20210 3

An error message pop-inrelated to electronic signatureconfiguration is partiallyobscured.

CHK-20216 3


4-34


When a tagger sendsa document to multiplesigners, but uploads a newdocument before the signershave provided the electronicsignature, Adobe Sign doesnot send email notification tothe recipients that the firstdocument has been cancelled.

CHK-20291 3

After a document hasbeen signed via electronicsignature, an Oracle SiteActivate user can see the filewithin the widget under FileHistory, but the file does notdisplay under File History for asite experience user.

CHK-20627 3

Global Search


When performing a searchwith results for a PI or Sub-Ithat is inactive or replaced, thesearch does not indicate thatthey are replaced.

CHK-10502 3

Global search does notreturn results when a searchkeyword has a dash (forexample: “Study-1068”).

CHK-10472 3

IP Release


After rejecting a reviewpackage and completing theactivities, if the user doubleclicks the Done button, twoidentical notes are created.

CHK-21747 3

It is possible for a user tomodify the expiration date ona completed item when itshould not be possible. AnArtifact API POST message istriggered by the date change,but the change does nottrigger an eTMF API publishmessage.

CHK-22848 3


4-35

Milestones


The icon that indicates that amilestone is at risk does notdisplay.

CHK-7855 3

On the home page Planningtab, when viewing Milestonesa duplicate tool tip displaysinstead of a single instance.

CHK-24393 4

After a user specifies amilestone is at risk and selectsa predefined reason or adds afree text for "Other" and saves,the previously selected reasonis not preselected if the usergoes back into the milestoneand wants to select anotherreason from the menu or adda new reason. The currentselection is visible at the topof the drop-down menu butnot in the expanded menu, asexpected.

CHK-27900 4

Single Sign On (SSO)


Clicking on a link insidean activities email notificationdirects the user to the IDPURL instead of the Oracle SiteActivate URL when IDP andOracle Site Activate URLs aredifferent.

CHK-23006 2

Site Experience


If a site user replies to analert email and does notinclude an attachment, andan Oracle Site Activate useraccepts the item within thequarantine area, no activitiesare completed and the statusicon erroneously shows an inprogress icon.

CHK-11105 3


4-36


When a site user discontinuesa submission, the submissionerroneously disappears fromSite experience.

CHK-16576 3

When a site experienceuser clicks on an alert, thecorresponding widget doesnot automatically expand asexpected.

CHK-20280 4

When configured for anaccount, a customer's logois not displayed in emailalert notifications to site usersas designed, even whenactivity completion by email isdisabled.

CHK-27912 3

Smart Site Library


Subcontracts in "Innegotiation" status are blockedfrom file upload in Smart SiteLibrary.

CHK-26726 3

When a PI was replaced, asite library user could seecompleted items when theseitems should not have beenavailable for selection.

CHK-28011 3

Staff Documents


If a staff document is assigneda display order number, andthen that staff member isdeactivated, the document willcontinue to display in theoriginal order, instead of at theend of the list.

CHK-10104 4


4-37

Study Library


When study library documentversions are created in quicksuccession, documents maycross over into differentversions of country levelplaceholders in lineage.

CHK-5985 3

In a newly created studysite or study country,multiple lineage documentsare created from the newversion of an already sharedstudy document.

CHK-8606 3

Submissions


Submission packages don’tdisplay staff names next tostaff-level documents; only thePI name displays.

CHK-971 3

If a reason is provided, usercan only see 1000 of thepotentially 3000 characters ofthe reason.

Workaround: See the fulldescription in the submissioninformation section of thesubmissions widget.

CHK-3230 3

When adding a new packageto a submission, additionalsites selected in planning donot have the initial submitdates from the first packageor any Final Approval baselineand planned dates that havebeen specified.

CHK-16825 3

On the submissions planningpage, the standard date formatis DDMMMYYYY, but whendates are set or updated,they display in non-standard,hyphenated format: DD-MMM-YYYY.

CHK-22928 4

Users are able to shareitem level notes with siteexperience users, which is notby design.

CHK-24766 3


4-38



On the team memberassignment page Site andStudy Country tabs, noconfirmation message displayswhen you assign a businessrole to multiple persons.

CHK-2235,

CHK-2231

4

Users who do not have studyor department administratorsystem roles can accessthe Team member and rolesassignment page.

CHK-4325 3

Study level assignments onlyshow when you select “For myrole” on the home page.

CHK-7925 2

After assigning a site roleto multiple users, no “rolesuccessfully applied” messagedisplays.

CHK-22611 4

After a user clicks “assign tome” for an activity, the user’sname is not immediatelydisplayed as an Assignee.


CHK-22836 4

User Interface


The site status pie chartdoes not accurately reflect sitestatus if the country status hasbeen changed to “on hold.”

CHK-20162 4

Under "File History" onan item (i.e., documents,submissions, packages,contracts), the “Previous files”toggle displays even whenthere are no previous files.

CHK-21705 4

When viewing contractexpiration date, the dateselection icon is not properlyaligned if the browser zoomlevel is set to any value otherthan 100%.

CHK-21874 3


4-39

Deprecated Known IssuesIssues in this section are no longer applicable (e.g., does not occur, will not beprioritized for fix, working as designed, and/or does not affect current functionality).We removed the item from the known issues list.

• API Integration

API Integration


Queued eTMF messagescould be sent without a fileif there are many messagesin the queue and over anhour elapses from the timethe queued messages processfrom start to finish.

CHK-27983 3

Chapter 4Deprecated Known Issues

4-40

5Severity Definitions

This section includes standard descriptions for issue severity levels.

Severity Description

1 Your production use of the supportedprograms is stopped or so severely impactedthat you cannot reasonably continue work. Youexperience a complete loss of service. Theoperation is mission critical to the businessand the situation is an emergency.

2 You experience a severe loss of service.Important features are unavailable with noacceptable workaround; however, operationscan continue in a restricted fashion.

3 You experience a minor loss of service. Theimpact is an inconvenience, which may requirea workaround to restore functionality

4 You request information, an enhancement,or documentation clarification regarding yoursoftware but there is no impact on theoperation of the software. You experience noloss of service. The result does not impede theoperation of a system.

5-1

6Browser Support

This section identifies browsers that have been tested with this release.

Our 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. The listof supported browsers for Oracle Site Activate and Oracle Site Activate LITE has notchanged with the 20.1 release.

Certified browsers undergo full testing for new features and regressions. Browserrelated issues found after release are prioritized for fixes in future patches or releases.

Supported browsers

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

Product Release Certified Supported

Oracle Site Activate 18.2 - 20.1 Chrome and IE 11 N/A

Site Experience andOracle Site ActivateLITE

19.1 - 19.4 Chrome and IE 11 Edge and Firefox

Site Experience andOracle Site ActivateLITE

18.2 - 18.4 Chrome and IE 11 IE 10 and IE 9

Note:

If you experience issues with a supported or certified browser, please submita trouble ticket or call Oracle Support at 1.877.230.4168 and provide thefollowing information:

• The browser version

• A description of your computer's basic environment

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

6-1

7Impact Analysis

This section describes business and functional impact for Oracle Site Activate release20.1.

Enhancement Enablement Setting Impact

API Integration

Artifact PUBLISH –Submission reason field

N/A Potential impact, integrationteams will need to account fornew field(s).

API Integration

Activity Dates PUBLISH –Submission at risk andSubmission at risk reasonfields


API Integration

Study Sites GET – Principalinvestigator, city, and matchtype fields


API Integration

Study Sites GET – Peoplefield (deprecated)

N/A No impact unless used.

API Integration

Study Site POST and StudySite PUT – Accept closedstatus


API Integration

GET APIs – CRO SponsorName field and queryparameter


API Integration

Studies POST, StudyCountries POST and StudySites POST – Box storagefolder

N/A No impact.

API Integration

Capture translation type

Must be enabled at theaccount and item level.

Translation type field displaysin TMF data section.

API Integration

eTMF, Artifact PUBLISH, andArtifact GET – Translation typefield


API Integration

PUT APIs – Year validation

N/A Theoretically no impact unlessa user wants to select a date athousand years in the future.

API Integration

IRB integration – Filter IRBdocuments

N/A No impact, usability feature

7-1


API Integration

IRB integration – Match file toitem flow

N/A No impact, usability feature,extra information displays

API Integration

IRB integration – Add a newitem flow

N/A Potential impact, previouslynot all protocol numbers wereavailable. Users now have alloptions.

API Integration

IRB integration – TMFidentifier

N/A No impact.

API Integration

IRB integration – ValidationAPI


API Integration

IRB integration – Upload toblocked item

N/A No impact on use, butpotential training point, userscan now match to blockeditems.

API Integration

Event messages – New filters


Document Management

TMF sub type and TMF Subsub type fields

N/A No impact, fields not in API yet

Milestones

Suggested Milestone Dates

N/A N/A

Milestones

Study level milestones

Purely configuration; noAdmin settings to enable.Configuration Designer useradds a study level standardmilestone then uses that tocreate a study level milestoneassociated to a study levelartifact activity. Once deployedthe milestone will be presenton any study using thatconfiguration.

Customers can now track theplan to finalize their study leveltemplates.

Might need to review thepermissions for study libraryusers- can they also planmilestones.

Chapter 7

7-2


Milestones

Milestone notes

No configuration or accountsetting changes required touse this feature.

Milestone notes use the sameNote Type LOV as other Notes(if enabled).

'Milestone' also includes thekey submission dates (Submitand Final Approval).

Works the same as otherNotes, any user can add anote to a milestone (user doesnot need the 'plan milestones'permission).

Any Oracle Site Activate userwith access to the study canread milestone notes.

Site Experience users cannotsee milestone notes, andmilestone notes cannot beshared with site users.

Milestone notes appear inthe notes tab, aggregatedwith other notes in reversechronological order.

Customers can now tracknotes related to specificcountry and site levelmilestones.

This feature can be usedin addition to MilestoneReplanning Reasons to furtherexplain delays or changes inmilestone completion dates.

Milestones

Milestones marked At Risk

Milestones at Risk featureneeds to be enabled in theAccount Settings.

Risk Reasons needs to bepopulated to present to usersan LOV to select from.

"Other" can be made availableas a selection, which would letthe user enter free text.

Milestones at Risk has beenenhanced to remove the at-risk icon in the UI once themilestone is completed.

New tooltip should make itmore clear why the milestoneis at-risk.

Milestones

Site milestone dashboard

N/A N/A

Site Engagement

Unified site experience

Site users will need to loginto each of their site accountsand select the "Link this<AccountName> account withsites page" checkbox. Oncea user has linked all desiredaccounts, they can login intoany of their site account anduse the "View activities forother sponsors/CRO's" buttonto review their linked accounts.

Site users can login into any oftheir site account and accessother linked site accounts.

Site Engagement

View only system role

N/A UI change only, API does notsupport at this time.

Site Engagement

Discontinue documents

N/A N/A

Chapter 7

7-3


Site Library

Drag and drop file upload

User musty simply havebusiness role with thepermission 'Enable documentupload, removal, and Typemanagement in Study Library'

All support file types aresupport just like if user uses'attach file' button instead ofdrag n drop.

Multiple files cannot bedropped into an item; an errormessage displays.

Easier experience foruploading files. Users don'thave to use finder to navigateto a file location.

Site Library

File replacement, preview, andremoval

User musty simply havebusiness role with thepermission 'Enable documentupload, removal, and Typemanagement in Study Library'

Easier experience foruploading files. Users don'thave to use finder to navigateto a file location.

Site Library

Document Type configurablelist of values

N/A N/A


CRO/Sponsor drop-downmenu

N/A N/A


Search results

N/A N/A

Other Enhancements

Microsoft .xlsm files

N/A N/A

Other Enhancements

Filter by favorite studies

N/A N/A

Other Enhancements

Branding

N/A N/A

Other Enhancements

Prioritized sites

N/A N/A

Other Enhancements

Session timeout

N/A N/A

Other Enhancements

Year validation

N/A N/A

Chapter 7

7-4

8Revision History

This section identifies published versions and associated book part numbers for theserelease notes.

Date Part Number Description

26Aug2020 F29577-06 Added hotfix 20.1.0.3(available for this release26Aug2020)

29Jul2020 F29577-05 Added hotfix 20.1.0.2(available for this release28Jul2020)

26Jun2020 F29577-04 Added hotfix 20.1.0.1(available for this release26Jun2020)

10Jun2020 F29577-03 Corrected 20.1 What'sNew Milestones section toadd missing description ofnew icon for changedmilestone dates. Added NewKnown Issue – MilestonesCHK-30426

10Apr2020 F29577-02 General Availability releasenotes

30Mar2020 F29577-01 Pre-General Availability(Feature Brief) version

8-1