cloud service oracle® health sciences site select release ... · intermittently, feasibility...

Oracle® Health Sciences Site SelectCloud ServiceRelease Notes

Release 20.1F29584-05May 2020

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

F29584-05

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Contents

Preface

Documentation accessibility vi

Related resources vi

Access to Oracle Support vi

1 Release 20.1.0.2 (available for this release 18May2020)

Stability Improvement 1-1

Workflow Tasks 1-1

2 Release 20.1.0.1 (available for this release 05May2020)

What's New 2-1

Oracle Site Select LITE 2-1

Stability Improvement 2-1

Data Sources 2-1

3 Release 20.1

What's New 3-1

Account Settings 3-1

Branding 3-2

Business Partner Collaboration 3-3

Data Import 3-6

Data Integration API 3-8

Digital Signature 3-8


Site Communications 3-16

Site Profile 3-17

Site Selection 3-18

Stability Improvements 3-18

Browser Compatibility 3-19

Dashboards 3-19

iii

Data Export 3-19

Data Sources 3-19


Document Management 3-20


Site Grid 3-21

Site Profile 3-21

New Known Issues 3-22

Business Partner Collaboration 3-22

Dashboards 3-23




Site Grid 3-24

Site Profile 3-24

Workflows 3-25

Previously Reported Known Issues 3-25

Browser Compatibility 3-26

Communications 3-26

CSV Download 3-27

Dashboards 3-27

Data Disambiguation 3-27

Data Sources 3-27


Feasibility Surveys 3-28

Milestones 3-29

Notes 3-30

Oracle Site Select / Oracle Site Activate Integration 3-30



Site Grid 3-31

Site Profile 3-32

Site Selection 3-32

Study Setup 3-33

Survey Response CSV/PDF 3-33

Task Management 3-33

User Interface 3-34

User Management 3-34

Deprecated Known Issues 3-34

Site Grid 3-35

iv

Impact Analysis 3-35

4 Severity Definitions

5 Browser Support

6 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 the OracleAccessibility 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 visit http://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-select/index.html

https://docs.oracle.com/en/industries/health-sciences/site-select/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

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

1Release 20.1.0.2 (available for this release18May2020)

This section describes the content of the 20.1.0.2 hotfix release.

• Stability ImprovementThis section identifies an issue fixed in this hotfix release.

Stability ImprovementThis section identifies an issue fixed in this hotfix release.

• Workflow Tasks

Workflow Tasks

Description Ticket Severity

Intermittently, feasibility surveytask completion was recordedin the Task completion detailspopover as "Completed by" forthe incorrect user name,although the completed surveywas associated to the correctsite. This issue did not assignsurvey response data to theincorrect user.

This fix ensures that thecorrect user name is recordedand displayed in the taskcompletion details popover forthe Complete feasibility surveytask.

SEL-9733 2

1-1

2Release 20.1.0.1 (available for this release05May2020)

This section describes the content of the 20.1.0.1 hotfix release.

• What's NewThis section identifies an improvement made in this hotfix release.

• Stability ImprovementThis section identifies an issue fixed in this hotfix release.

What's NewThis section identifies an improvement made in this hotfix release.

• Oracle Site Select LITE

Oracle Site Select LITEWe revised Help documentation in Oracle Site Select LITE to reflect user interfaceenhancements introduced in release 20.1.

Stability ImprovementThis section identifies an issue fixed in this hotfix release.

• Data Sources

Data Sources


When a data sourceassociated with a study wasdeleted, all sites in the studyfrom that data source wouldalso be deleted. We changeddeletion behavior to retainsites that have moved beyondthe master list, even if there isno longer a data sourceassociated with the study.

SEL-9630 3

2-1

3Release 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.

• 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.

• Impact AnalysisThis section describes business and functional impact for Oracle Site Selectrelease 20.1.

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

• Account Settings

• Branding

• Business Partner Collaboration

• Data Import

• Data Integration API

• Digital Signature


• Site Communications

• Site Profile

• Site Selection

Account SettingsWith this release, we enhanced Oracle Site Select global navigation to group account-level items under a new “Account” drop-down menu in the global navigation bar. TheAccount menu displays only if the user is an administrator who has permissions toaccess one or more items included in the new menu, and only those items to whichthe user has been granted access display in the menu.

3-1

The Account menu includes the following items:

• Account data sources

• Data source matches

• Users and roles

• Business partner collaborator teams

• Teams

• Authentication and API configuration

With the exception of the new "business partner collaborator teams" item, the Accountmenu items listed above were previously included in the Setup or Manage menus. Thecontent of Setup and Manage menus is now:

• Setup

– Manage study details

– Site scoring

– Email templates

– Site workflow configuration

– Manage protocol documents

– CDAs, confidentiality statements, and generic documents

– Feasibility survey

– Milestones

– Manage reasons for study exclusion/disinterest

Manage

– Site communications

– Document approvals

– Study data sources

– Data source query

BrandingWith release 20.1, we finalized branding enhancements that began in release 19.4. Ingeneral, the enhancement scope included replacing "goBalto" with "Oracle" and

Chapter 3What's New

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updating several areas with blue color palette to match other areas of the application.Below is a representative example of the enhancement scope but is not an exhaustivelist of all updates.

• Oracle Site Select

– Replaced all "goBalto" references with "Oracle" in page names, drop-downmenus, tool tips, FAQs, email subject lines, error message text, etc.

– Updated drop-down menu highlighting to blue

– Updated action/confirmation buttons to blue (e.g., "Done," invitation email "Nologin" and "Login Required" buttons, etc.)

• Oracle Site Select API documentation

– Replaced "goBalto" references with references to "Oracle" where appropriate(e.g., page headings). Note that integration URLs and documented API routeheader fields were not modified as part of this enhancement effort.


– Updated branding elements on email notification (e.g., button color, logo, etc.)and removed "goBalto" references

Business Partner CollaborationWith release 20.1, Oracle Site Select introduces redesigned business partnercollaboration functionality that alters the previous implementation to provide for greaterflexibility. Now, studies are housed in the study owner account (e.g., sponsor) and

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study owners can grant collaborators (e.g., CRO users) access to studies viacollaboration team permissions.

Note:

An Oracle administrative user enables partner relationship between the studyowner account and the collaborator account. Please contact your OracleProject Manager to discuss scheduling and business requirements.

New and removed permissions

This enhancement introduces new Oracle Site Select permissions:

• Business partner collaborator user – User in the collaborator account who canbe assigned to a study owner's study

• Manage business partner collaboration users – For accounts set as a businesspartner collaborator, this permission allows for managing the users assigned the“Business partner collaboration user” permission to define to which study ownersthe collaboration users are available as a resource

• Manage business partner collaborator teams – Study owner user can definebusiness partner collaboration team permissions for collaboration users onspecified studies

With release 20.1, we removed the previously-available “Business partnercollaborator” permission from the permissions list.

Collaborator users

Collaborator users included in at least one collaboration team with study access willnow see a new “Accounts” drop-down menu in the Oracle Site Select top navigation.The menu lists the Oracle Site Select user’s “primary” account (e.g., the collaboratoraccount to which the user authenticates) as well as the study owner account(s) towhich the user has been assigned to a team with study access.

The Accounts drop-down menu allows the collaborator user to quickly swap toassigned Oracle Site Select studies. When the collaborator user chooses:

• the “primary” collaborator account, the Studies drop-down menu includes onlythose studies to which the user is permissioned within the primary account andteams and permissions granted in the primary account remain in place

• a study owner account, the Studies drop-down menu includes only those studiesthe user is permissioned to access (as defined by the applied collaborationteam(s) for the study owner account). A collaboration user entering a studyowner's study loses all permissions and team assignments granted to the userfrom primary account (because the study owner team controls permissions in thestudy owner account). Additionally:

– A collaboration user assigned to a study owner's study and assigned to a sitethat has yet to be invited to the study will have their email address used as thereply-to email address when the site is invited to the study.

– A collaboration user assigned to a study owner's study can be assigned as areviewer for a CDA (when granted the appropriate permissions in the studyowner's collaboration team) and receives all associated CDA negotiationemails.

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– A collaboration user assigned to a study owner's study can save a study andsite level note (when granted the appropriate permissions in the study-owner'scollaboration team). The user’s name will reflect in the note's record and in theaudit log.

– A collaboration user assigned to a study owner's study, and assigned to a site,and granted the restriction of "View/manage assigned sites only" as acollaboration team from within the study-owner's account, will see only theassigned site in all site grids when viewing this study owner's study.

Note:

The collaborator user’s Oracle Site Select login method is not affected byany associated business partner account login settings. The configured loginmethod for the collaborator user’s primary account (i.e., Single Sign On(SSO) or User ID and password credentials) is enforced.

Report access

The business partner collaboration feature provides study owners with the option toallow collaborator users to access the study owner's study-level Site Progress reportsin Oracle Site Analyze. If the user has been added to a collaboration team thatincludes report access permission, the user will access the study owner report datausing the “Analyze Reports” link in the Oracle Site Select dashboard drop-down menu.The following is expected behavior for Site Progress report collaboration user access:

• The user will be created in his or her “primary” Oracle Site Analyze account not thestudy owner's Oracle Site Analyze account.

• A user who has access to reports in his or her "primary" account can accessOracle Site Analyze and also see reports associated with the study owner’sstudies (those which the user has been given Oracle Site Analyze access via acollaboration team) in addition to the reports for which the user is permissioned inhis or her "primary" account.

• A user who is not granted Oracle Site Analyze access/permission in their "primary"account can access Oracle Site Analyze and see reports associated with the studyowner’s studies for which they are given Oracle Site Analyze access via acollaboration team. This user will not see reports for studies in his or her "primary"account.

Remove the business partner collaboration

Upon request, an Oracle administrative user can remove the business partnerrelationship between a study owner and a collaborator at the study owner’s accountlevel. Doing so removes access for all collaboration users and deletes all associatedbusiness partner settings for the account association. The following is the expectedbehavior:

• All collaboration users from that collaborator with access to the study owner'sstudies lose access

• All collaboration teams defined in the study owner's account are removed/deletedfor that collaborator

• All study owner studies with that collaborator are toggled off for business partnercollaboration and the chosen collaborator is removed/reset to blank

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• If toggled back on, all collaboration teams, partnerships, modals, and chosencollaborators reset to blank

• The study owner is removed from the collaboration partner's drop-down menu ofstudy owners

Data ImportDiscontinued records

Oracle Site Select users who manage data sources can now upload a data source thatincludes records flagged as “discontinued” at the institution, investigator, or site levels.When flagged as discontinued, Oracle Site Select filters all sites correlated to theinstitution/investigator/site/trial-site from master list generation, except as describedbelow.

When multiple data sources exist for a study, data source priority as well as recordupdates (e.g., changing a discontinued setting from “true” to “false”) may allow thedisplay of a discontinued site in the master list/nominate bucket. The following listdetails expected behaviors for this feature with release 20.1:

• A site currently in the nominate bucket that later has the discontinue flag set totrue remains in the nominate bucket unless another action, such as changing thepriority of study data sources, triggers the rebuild of the master list.

• If the discontinue flag for the institution/investigator/site record is false and the siteis nominated and moved beyond the nominate bucket, and later the discontinueflag is updated to true, Oracle Site Select will maintain the site record in the sitegrid and preserve the underlying data that contributes to the site record from theoriginating data sources (regardless of site profile record). In this case the site'sinvestigator name will be formatted in maroon text with an accompanying alert icon( ) displays in the grid.

Note:

A site profile record that shares a master profile ID with an institution/investigator/site will be filtered based on the criteria above only when adata source with the discontinue flag set to true is attached to the study.

• The master list will not automatically regenerate if an attached data source has theinstitution/investigator/site discontinue flag set to true and the flag is later updatedto false. However, if an Oracle Site Select user triggers master list regeneration(e.g., by changing the priority of study data sources) the site will be filteredaccording to the expected behavior described above.

• When two data sources are attached to a study and the higher priority data sourcehas the discontinue flag set to true, the site is filtered from nomination/master listalong with any associated site profile record. However, when two data sources areattached to a study and the higher priority data source has the discontinue flag setto false, but the lower priority data source has the flag set to true, the site/siteprofile record is not filtered from nomination/master list.

• A site record with preferred and/or preselected site set to true and discontinue setto true will be included in the master list provided the preferred site and/orpreselected site check box setting is enabled on the study parameters page. Therecord from the CSV where preferred_site=true and/or preselected_site=true will

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be the record that persists. Again, in this case, the site's investigator name will beformatted in maroon text with an accompanying alert icon ( ) displays in the grid.

These records provide hover over tool tip text and display the discontinue reason, ifavailable. Users can also optionally include an institution/investigator/site discontinuereason column in the grid, if preferred.

Relabeled "Last import date"

Because data source activity can now refer to either an import or a delete action, onthe "Account data source management" page, we relabeled the "Last import date"column to "Last Activity." We also updated the associated import data page to updatethe "Last import details" section label to "Last activity details."

This modification also applied to the Datasource and Composite Datasource CountsAPI response. We've updated the response to replace last_import_date withlast_activity_date. We updated Oracle Site Select API documentation to reflect thischange as well. Oracle Site Select users can access the updated information from the"API documentation" link in the Oracle Site Select global navigation.

Boolean default values

With this release we modified application of Oracle Site Select default column valuesfor composite data sources. Now, when a standard Oracle Site Select Boolean columnhas a default value set, and the column is being used with a datasource, when a siterecord is imported into that datasource but does not specify a value for that Booleancolumn, the column's default value will be used.

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Data Integration APIFor composite data sources, new DELETE calls for trial and trial site endpoints allowcustomers to physically delete data that should not exist in Oracle Site Select (e.g.,data uploaded/created in error).

• Trial – This call physically deletes a trial record and all associated trial site recordsfrom a datasource

• Trial Site – This call physically deletes a single trial site record from a datasource

We updated Oracle Site Select API documentation to include the new trial and trial siteDELETE routes. Users can access this information from the "API documentation" linkin the Oracle Site Select global navigation to view request requirements, successfuland failed response examples, and route options.

Digital SignatureRelease 20.1 includes multiple digital signature feature enhancements that simplify theprocess and provide sites with improved guidance on signature steps.

Site initiated digital signature transaction

Site users can now initiate a CDA digital signature transaction when:

1. The CDA workflow task is enabled for digital signature

2. The CDA does not have an assigned site signer

3. The CDA is not currently in a “Pending review” or “Pending final review” status and

4. No other active digital signature transaction exists for the study-site

When all four of the above conditions are true, Oracle Site Select LITE will displaymessaging that the user will receive a link via Adobe Sign email to digitally sign thedocument. The messaging displayed in Oracle Site Select LITE will also note the userhas the option to manually upload a signed CDA, if preferred. If the site user choosesto initiate the transaction, default private message text will be included in the AdobeSign transaction as follows below (this private message text will not display in OracleSite Select LITE):

• Site signer: You initiated this digital signature for study: <study name> on: <digitalsignature transaction creation date>

• Counter signer: The site user <site user who created the transaction> createdthis digital signature transaction on <digital signature transaction creation date> forthe study: <study name>.

When a workflow task does not specify a default counter signer, Adobe Sign createsthe transaction with only the site user who initiates the transaction. If a CDA workflowtask does specify a default counter signer, the Adobe Sign transaction includes thesite signer as the initiating Oracle Site Select LITE user and then the workflow-definedcounter signer, in that order.

If Adobe Sign fails to successfully create the transaction, the following error messagesdisplay in Oracle Site Select LITE:

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• Counter signer is not valid: "There was a problem creating the digital signaturetransaction. No valid counter signer specified. Please contact your studyadministrator to resolve the issue."

• Other issue: “There was a problem creating the digital signature transaction. Youmay try again later or contact your study administrator to resolve the issue.”

Note:

A site user may not initiate a digital signature transaction on a CDA returnedvia the action "Site resubmission required.” This is by design, as the OracleSite Select user choosing that action is assumed to require the site toprovide edits before allowing site signature.

Document action modal

Because some organizations do not use counter signatures for CDAs, we removed therequirement that Oracle Site Select users specify a counter signer in the Documentaction modal. We also added email address to the modal's Site Signer and CounterSigner drop-down menus to help users choose the correct signer.

Workflow task configuration

We enhanced CDA workflow task configuration to provide a field where an Oracle SiteSelect user can optionally specify an individual as the default assigned CDA countersigner. When populated, the individual’s name automatically populates in theDocument action modal’s Counter Signer field with an asterisk preceding the name.The Oracle Site Select user can still include an optional, free-text comment for theassigned counter signer, if preferred.

If the configured default counter signer is ineligible for counter signature (e.g., useraccount lock, insufficient permissions, etc.), the Document action modal displays anerror.

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Oracle Site Select LITE messaging

Note:

Learn more about the new Oracle Site Select LITE home page in the OracleSite Select LITE redesign section of these release notes

When a CDA has been sent to a site for digital signature (i.e., the Adobe Signtransaction is pending), the CDA’s task panel in Oracle Site Select LITE replaces the“Submit” button and instead displays two different text messages depending uponwhether or not the user is the assigned site signer.

Text displayed user assigned to digitally sign the CDA:

“You have been assigned as the digital signer for this document.

Please check your email for a document link from Adobe sign. You will be required tolog in with your Adobe Sign credentials to complete the signature process.

If you are new to Adobe sign, an account has been created for you. Please check youremail to activate your account before proceeding with the signature process.

If this is in error, please contact your study administrator.

You can still choose to manually sign, scan and upload a copy of the documentinstead.”

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The “upload” text (underlined for reference in the last line of the message above) is ahyperlink that opens the CDA upload modal. If the assigned digital signature signerchooses to manually upload a signed CDA, the user does not have to download themost recent CDA before uploading a wet ink signed CDA.

Text displayed to site user who is not the assigned site signer:

“This document has been assigned to <Assigned User> at <Assigned User Email> fordigital signature. If this is in error, please contact your study administrator.

You can still choose to manually sign, scan and upload a copy of the documentinstead.”

The “upload” link (underlined for reference in the last line of the text above) opens theCDA upload modal if the site user chooses to manually upload a signed CDA insteadof following the digital signature process. For this unassigned site user, the CDAupload does not require a CDA download when the CDA is pending a digital signature,and the site user can download the most recent CDA template and comment/upload a"wet ink" CDA – even if the user is not the digital signature assigned signer.

Oracle Site Select LITEOracle Site Select LITE redesign

With enhancements made in this release, the Oracle Site Select LITE landing pagenow has a new design and provides sites with additional study and workflow taskinformation. Oracle Site Select users can now include free text study workflowinformation of up to 3,000 characters. The workflow information statement, which isconfigured on the Oracle Site Select “Manage site workflow configuration” page,displays just above the site’s assigned tasks. By default, the first two lines of textdisplay, and if additional information exists beyond the first to lines, the site user canclick “read more” to expand the statement panel. When no study information text hasbeen saved for the workflow, the panel is not visible to site users.

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We also redesigned the workflow task area to optimize use of horizontal space, andwe removed the previous subway style progress graph. Now, workflow tasks listvertically on the left side of the page, and site users can quickly evaluate task progressusing the color coded and enumerated key displayed above the task list.

For each selected workflow task, a detail panel displays to the right. The panelincludes task information previously available to site users (e.g., task name, age, andaction), and with this release we also added "Task information." Task information is anoptional, descriptive free text of up to 2,000 characters that an Oracle Site Select usercan configure on the Oracle Site Select “Manage site workflow configuration” page.Like the workflow information text described above, the Task information area doesnot display in the detail panel if the individual workflow task has no text configured.

We also made a minor user interface change to the institution name displayed at theupper right of the Oracle Site Select LITE home page. The name now displays in blacktext with an increased font size.

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Responsive design

With this release, we added responsive design updates to the Oracle Site Select LITElogin page and all pages under the “Need help?” section of the login page. The pagesnow adjust text orientation and input options to screen sizes that correspond to smallerdisplays, such as those on mobile devices.

Single Sign On (SSO) for sites

With this release, Oracle Site Select introduces Single Sign On (SSO) authenticationfor site users. SSO authentication allows sites to access their studies via integrationbetween Oracle Site Select and an identity provider (IDP) application (e.g., acustomer-managed portal).

When the "Enable Select Lite" option has been enabled on the Study Details page,Oracle Site Select users who have permission to access the Authentication and APIconfiguration page will configure SSO for sites in the "Authentication options" sectionof the page.

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When a site accesses Oracle Site Select LITE via SSO authentication, studies towhich the site has access are limited to those in which the site has been invited toparticipate within the logged-in account. However, by design, site users have theability to log in to Oracle Site Select LITE manually to access studies in anotheraccount, if necessary.

Upon timeout or manual logout, Oracle Site Select LITE users who logged in:

• With SSO are redirected to their IDP

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• With user name and password are redirected to the Oracle Site Select LITElogin page

Note:

The user profile "Forgot password?" feature was not modified with the SSOfor sites enhancement and continues to function as it did previously for userswho log in to Oracle Site Select LITE using user name and passwordcredentials. The "Forgot password?" feature does not allow sites to managetheir IDP password.

Site user self-unlock

Now it’s easier for Oracle Site Select LITE users to unlock their accounts whennecessary (e.g., when a site user's account is locked due to repeated failed loginattempts). With this release, we introduce self-unlock, which provides options for theuser to unlock his or her account via email password reset.

Email notification

The locked user receives an email with the subject “Your Oracle Select LITE accounthas been locked,” and the email includes a timed link to a password reset page.Because this email is not sent to the user in the context of any study, it will not supportemail template preferences and will transmit from the generic Oracle Site Selectsystem admin account email address.

Login page

• Login page messaging informs the user that the login credentials are not valid anddirects the user to links in the “Need help?” section

• “Need help?” section “Forgot your password?” link allows the user to request anemail with password reset instructions

• “Need help?” section “Trouble accessing your account?” link allows the user torequest an email with instructions for resetting account access

Both “Need help?” links above require the user to reset the account password.

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Note:

For security reasons, login pages no longer specify that a login failed due tothe account being locked. The message displayed for both Oracle Site SelectLITE and Oracle Site Select users now states that the email address and/orpassword are incorrect.

Email-verified Oracle Site Select LITE account activation

We enhanced site user account activation to now require email verification for accountcreation. When a site who accessed Oracle Site Select LITE using a study invitation“No login” link (i.e., user is “Logged in as guest”) clicks the “create account” option inthe drop-down menu below the “Logged in as guest” menu:

1. Oracle Site Select LITE sends an account creation link to the site user’s email, and

2. The site user is automatically redirected to an email verification page.

The “Verify your email…” page includes a statement in red text that specifies the emailaddress where Oracle Site Select LITE sent the account creation link. The user canthen locate the email, click the account creation link in the email, and proceed withsetting an account password prior to login. If the user did not receive the email, theaccount creation link can be resent by entering the email on the "Verify your email..."page and clicking Resend.

Site CommunicationsOracle Site Select customers now have the option to specify text to replace the default"Log in required" button text in emails sent to sites. Users who have permission toaccess the Authentication and API Configuration page can specify up to 20alphanumeric characters of custom button text. Special characters are also allowed,and Oracle Site Select will preserve text case. Rich Text is not supported.

Chapter 3What's New

3-16

All site-facing email notifications that include an Oracle Site Select LITE login optionwill have the text for the login button specified by the setting on the Authentication andAPI configuration page. These emails include, but are not limited to:

• Site welcome invitation

• New site user email digest

• CDA requires resubmission

• CDA final approval

Site ProfileIRB Coordinator email address field helper text now correctly describes expectedbehavior when an Oracle Site Select user updates one or both fields in the Site Profile,Contacts tab. Now, the helper text displays as follows:

"Updating the IRB Coordinator's email address could affect active studies.

Please note: Updating the email address will send a new email digest with links foreach study this user is associated with. Invitations sent to the former email address (ifany) will no longer be valid and the associated Select lite account will be removed. Ifyou are changing your own email address, you will need to log into Select lite usingyour new invitation email."

Chapter 3What's New

3-17

Site SelectionWith this release we enhanced all workflow status popovers and the "Accessed SelectLITE" popover in the Site progress tab to reflect the historical name of the user whocompleted the action. This enhancement ensures that even if a user's name changes,the popover displays the user name as is was at the time of the action. We also addedemail as a column in the Site progress workflow task completion popover.

Stability ImprovementsThis section identifies issues fixed in this release.

• Browser Compatibility

• Dashboards

Chapter 3Stability Improvements

3-18

• Data Export

• Data Sources


• Document Management


• Site Grid

• Site Profile

Browser Compatibility


In Internet Explorer 11,scrolling down the study listcaused the top result to behidden by the currentlyselected study.

SEL-7789 3

Dashboards


The Site counts dashboarddisplayed inaccurate chartdata and data load wasdelayed.

SEL-9043 3

Data Export


If a site was in the FinalAcceptance bucket state, dataexports using the"selected_at" value could haveincorrectly reflected the datethe site was finalized andcould instead have reflectedthe last date of a site profileupdate.

SEL-8669 3

Data Sources


Users were unable to deletedata sources that had a veryhigh number of records.

SEL-8805 3


3-19

Digital Signature


CDAs sent for digital signaturebut uploaded by the site with awet ink signature incorrectlyshowed as a "D signature" inthe Final Review tab ofmanage document approvals.

SEL-8695 3

Document Management


When a workflow includedboth CDA and ConfidentialityStatement activities, and theCDA included a fileattachment with data mergefield placeholders, theplaceholder fields were notpopulated with study siteprofile data as expected whenOracle Site Select LITE usersopened the document.

SEL-9008 3

Site Communications


An email address added to aPrincipal Investigator via datasource, not site profile, shouldnot have received a finalacceptance email, as the finalacceptance email should havebeen limited to the scope ofthe site profile.

SEL-8945 3

The notification email sent tosite users when their sitereceived a site communicationincorrectly populated therecipient's name in the firstsentence. Instead of "... <piname> at <institution name>,"the first sentence in thenotification populated"<recipient name> at<institution name>."

SEL-9019 3

Site users were unable tocreate a Oracle Site SelectLITE account using the "Youhave been added as a sitecontact" email notification.

SEL-9103 3


3-20


When the email templaterecipient was set to PrincipalInvestigator + Clinical TrialCoordinator, and a user addeda new Institution staff in thesite profile, and the user thenadded that staff member to theStudy Contacts, the study-specific email invitation did notreflect the assigned user asthe sender of the email asexpected.

SEL-9339 2

Site Grid


Text did not display for anysite, Principal Investigator, orInstitution column when usersadded columns to the site gridon step 3 (select), Surveyanalysis tab.

SEL-8884 3

Site Profile


After a user successfullysaved an institution staffmember's information, andthat staff member wassubsequently removed fromthe Study contacts tab, if thestaff member's name waschanged and the staff memberwas re-added to Studycontacts, the grid did notreflect the updated name uponsaving.

SEL-8581 3

After adding all available usersto the grid on the Studycontacts tab, the "Add" buttonwas not disabled as expectedand users could erroneouslyadd multiple empty rows.

SEL-8674 3


3-21


When the email templatepreferences were set to "Boththe Principal Investigator andthe Clinical Trial Coordinator"and there was an institutionstaff designated as "CTC" inthe Study contacts tab for aninvited site, that CTC user didnot receive email notificationsas expected for messagessent via site communicationsportal.

SEL-8713 3

When the email templatepreference was set to"Principal Investigator" only,the Add button on the Studycontacts tab was not enabledso that users could add newlyinvited site users whenappropriate.

SEL-9114 2

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

• Business Partner Collaboration

• Dashboards




• Site Grid

• Site Profile

• Workflows

Business Partner Collaboration


A collaboration user who losesaccess to a study owneraccount will be stuck in thestudy owner's account (i.e.,unable to access his or her"primary" account).

Workaround: Log out and logback in to access the primaryaccount.

SEL-9482 3

Chapter 3New Known Issues

3-22

Dashboards


When a bar on the Site countsdashboard "Cycle timeaverages across study" graphis too high, the hover-over popup that displays above the baris hidden.

SEL-9173 3

Digital Signature


When a CDA workflow taskhas an inactive user assignedas a default counter signer,Oracle Site Select LITE userswill receive an error whenattempting to initiate a digitalsignature transaction, and theCDA task is no longeractionable in Oracle SiteSelect LITE. Within OracleSite Select, under DocumentApprovals, the CDA moves toRequires Review status.

Workaround: Acting on behalfof the site, a Oracle SiteSelect user can upload thedocument for the CDA task,after which a Oracle SiteSelect user can re-initiated theCDA transaction from the CDAdocument approval page.

SEL-9525 3

Document Management


When two workflows arecreated using the default"Standard + no CDA" workflowor "Standard + confidential"workflow, the user receives anerror when attempting toupload the document on theManage CDAs, confidentialitystatements... page.

SEL-9018 3


3-23

Oracle Site Select LITE


Text in a workflow task panel's"Task information" sectiontruncates with an ellipsis after2,000 characters, and whenthe text contains very longwords, users are unable toexpand the text to view the fullword.

SEL-9219 3

In some instances, text in aworkflow task panel's "Taskinformation" section does nottruncate with an ellipsis whenthe text exceeds two lines, butwhen the user clicks on thetext to expand, the full textdisplays.

SEL-9220 4

Site Grid


When a user clicks "Senddecline" in the Finalization/Declined bucket, the progressspinner label incorrectly reads"Sending acceptanceemails..." instead of "Sendingdecline emails."

SEL-9178 4

The Site Notes tab does notdisplay as designed whenusers "View notes" fromActions in step 3 (select),Invited bucket.

SEL-9072 3

Site Profile


On the Study contacts tab, the"Role" drop-down menu doesnot honor country-specificemail recipient templatesettings. Instead, it applies thedefault email templatesettings.

SEL-9072 4


3-24


When populating theInstitution phone and/or faxnumber fields in the siteprofile, there is no indicationthat both the number and typefields must be populated tosave the change in site profile.

SEL-9275 3

Workflows


When creating a new workflowthat includes a Genericdocument task, the help(question mark) icons do notdisplay help text as designed,and task option labels andcheckboxes for an unassignedworkflow display in gray(meaning they are noteditable) when they shoulddisplay in black (editable) foran unassigned workflow.

SEL-9504 3

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

• Browser Compatibility

• Communications

• CSV Download

• Dashboards

• Data Disambiguation

• Data Sources


• Feasibility Surveys

• Milestones

• Notes

• Oracle Site Select / Oracle Site Activate Integration



• Site Grid

• Site Profile

• Site Selection

Chapter 3Previously Reported Known Issues

3-25

• Study Setup

• Survey Response CSV/PDF

• Task Management

• User Interface

• User Management

Browser Compatibility


When using the Chromebrowser on Windows only,dragging fields in the datasource mapping tool makesthem difficult to see untildropped onto another field.

SEL-2042 4

When using the InternetExplorer 11 browser, on theManage Workflow page, userscannot select text or positionthe cursor anywhere in a textfield using the mouse.

Workaround: To select text,use Ctrl-A or tab into the fieldfrom another field.

SEL-2642 3

If a Oracle Site Select LITEuser copies and pastes the“No login” link from aninvitation email into a Chromebrowser incognito window, theuser is then unable to uploada signed CDA from OracleSite Select LITE.

SEL-4737 3

When using the Chromebrowser and viewing the Shortlist site grid, the grid does notremain aligned when scrolling.

SEL-5531 4

Communications


When a registered Oracle SiteSelect LITE user is locked outof his/her account, Oracle SiteSelect displays a notice oflockout status on the loginpage, but no email is sent tothe user who invited the siteinforming the individual thatthe Oracle Site Select LITEuser account is locked.

SEL-6546 3


3-26

CSV Download


When users download a CSVfrom the Investigator or Sitestab on the Nominate step,dropped list, the CSV displaysa “Declined by” columninstead of “Dropped by”column.

SEL-5375 4

Dashboards


Intermittently, the“Participating?” and “4thinvitation sent” columns do notdisplay on the email invitationspage.

SEL-5384 3

Data Disambiguation


After resolving a record matchon the Resolve data sourcematches page, the PI emailfield continues to displayinstead of dropping out of viewas designed.

SEL-4950 3

Data Sources


The account dataadministrator is preventedfrom removing a public datasource, but the remove buttondoes not currently reflect adisabled state when choosinga public data source.

SEL-4525 4

Oracle Site Select does notblock account deletion whenan account has existingprivate data sources, whichcan result in orphaned datasources after account deletion.

SEL-4788 3


3-27


Users receive an error whenattempting to delete anunpublished data source, andthe unpublished data sourcethen changes to publishedafter the error.

SEL-4913 3

Document Management


After approving a documenton the Document approvalspage, Requires approval tab,a success message shoulddisplay.

SEL-5341 3

If a CDA or generic documenthas not been downloaded orsubmitted for a study, thetarget graphs on theDocument approvals page donot display.

SEL-5395 4

Workflow and task names arenot displayed on theDocument approvals page asexpected when viewing acountry-level genericdocument.

SEL-5749 3

When a user submits ageneric document on behalf ofa site, the user is not given anoption to include a commentwith the document, asdesigned.

SEL-8672 3

Feasibility Surveys


When attempting toreauthorize the Oracle SiteSelect account withSurveyMonkey, users arererouted to Oracle Site Selectinstead of SurveyMonkey andaccount edits are not saved.

SEL-4419 3

The words “feasibility survey”are not displayed in the tool tipfor incomplete workflows.

SEL-5703 3


3-28


For Survey Monkey star ratingtype questions, Oracle SiteSelect incorrectly parsesincoming data.

Please refrain from usingthis question type until thisissue is resolved.

SEL-5784 4

When a user completes asurvey using the Chromebrowser in Incognito mode, atruncated screen withhorizontal and vertical scrollbars displays instead of thesurvey completion screen.

SEL-8057 4

When a survey includes morethan one page of scorablequestions, the survey scoringtool does not allow users toexpand the last surveyquestion on the page (i.e.,question 10) to display thequestion point value fields.

Workaround: Expand thesecond to last question(question 9) so the UI expandsdown. Expand question 10(the last question). Now the UIhas space to show the scoremapping for question 10.

SEL-8742 2

Milestones


It is not possible to directlydelete text values in any fieldon the Manage Milestonespage.

Workaround: To change atext value, select the value inthe field and overwrite it with anew value.

SEL-2474 3

Country level milestones donot automatically populatewhen adding dates to thestudy.

SEL-3831 3


3-29

Notes


Site notes are not available inthe site communication portalwhen a user clicks the Notesicon.

SEL-7703 3

In Internet Explorer 11, thenotes dialog does not displayexpected helper text, "Enter anew study note" in the lowerpart of the dialog.

SEL-7738 4

Oracle Site Select / Oracle Site Activate Integration


When the maximum numberof sites (400) are migrated inbulk to a new or existing studyin Oracle Site Activate, thestatus icons for each site donot reflect a successfulmigration until the page isrefreshed.

SEL-3630

SEL-3631

3



Authenticated Oracle SiteSelect LITE users will see an"Attach" button in theDocument Library that onlypartially displays, but is stillfunctional.

SEL-2492 3

In Internet Explorer 11, whena user updates site details andclicks Done, the user is notredirected to the Home page,as expected.

SEL-4963 4

When a site selects theDownload link for a CDA, theActions menu is not availableas expected and the hover-over tool tip directs the site todownload the document.

SEL-6493 3


3-30

Site Communications


Sortable columns on the sitecommunications table do notinclude a column header iconindicating they are sortable.

SEL-2654 3

The Oracle Site Select sitecommunications portal did notdisplay site notes as designedwhen a user clicked the notesicon.

SEL-7703 3

Site users are unable to createa Oracle Site Select LITEaccount using the "You havebeen added as a site contact"email notification.

Workarounds:

1. Use the Oracle SiteSelect LITE link copyfeature (introduced inpatch release 19.4.1) tosend an email invitation,which will be sent from"[email protected]"sender. The No login linksfunction as expected inthis email.

2. Resend the emailinvitation to users. The Nologin link works in theinitial and resent emailinvitations.

SEL-9103 3

Site Grid


On step 3 (select), SiteProgress sub-tab, the site gridcolumn heading for "Workflowclose date" does not displayas expected.

SEL-6612 3


3-31


When a site is assigned aworkflow that includes theVerify site interest or Verifysite interest again task, andthe site indicates “No” for thetask, the previous task isdisplayed as the lastcompleted task in the site grid,rather than the Verify siteinterest/Verify site interestagain task.

SEL-6900 33

On step 3 (select), when userssort the site grid by CDAStatus column and there aremultiple pages of sites in thegrid, the number of sitesdisplayed per page isinconsistent.

SEL-7294 4

On step 3 (select), Siteprogress tab, the icondisplayed in the "DisinterestReason" column should bedisabled for sites that haveexpressed interest or have notyet answered.

SEL-8108 4

Site Profile


Helper text above the PI andCTC email fields in the siteprofile does not correctlyreflect email communicationslogic for email addressupdates.

SEL-8733 3

When multiple "Additionalstaff" users have been addedto the Institution Contactssection, the staff names arenot properly aligned in theuser interface.

SEL-8826 4

Site Selection


Users are not prevented fromreversing site finalization whenthe site has already beenmigrated to Oracle SiteActivate.

SEL-5775 3


3-32

Study Setup


Reordering the list of sitedecline and disinterestreasons does not immediatelydisplay the updated list.

Workaround: Refresh thepage.

SEL-6200 3

On the workflow configurationpage, when the study has atleast one workflow in use anda new workflow, when a userupdates the new workflow andreturns to the in use workflow,an individual workflow task nolonger displays when the userattempts to drag it to a newposition.

Workaround: Refresh thepage.

SEL-8207 3

Survey Response CSV/PDF


In the survey response PDF, ifthe site’s selected answer fallsjust before a page break, thecheck mark indicating theselected answer displays atthe top of the next page.

SEL-6529 4

Task Management


Visiting the Manage milestonepage before Workflowconfiguration has been set willdisplay a blank milestonespage. Clicking Done on thispage will remove the task fromthe list even thoughmilestones have not been set.

SEL-2225 3


3-33

User Interface


When users manually reducebrowser window size,horizontal scroll bars do notexpand the full width of thewindow to allow access to allcontent on the page.

SEL-4158 4

When creating or editing a siteworkflow configuration, taskorder numbers do not properlyalign if the workflow includes aGeneric document task.

SEL-4224 3

On the CDA approvals page,the CDA box border linesappear/disappear when a userchanges the browser zoomlevel.

SEL-4994 4

When selecting columnsunder the “Site” section, thefocus is on the bottom of theexpanded view instead of thetop as designed.

SEL-5086 4

Site grid columns becomemisaligned when users scrollup and down.

SEL-5196 3

On the Manage study detailspage, the Country,Specializations, andTherapeutic Areas drop-downselection boxes remain openwhen the user navigates awayto a different element on thepage.

SEL-5524 3

User Management


Roles pop-up displaysdifferent roles when searchingby user vs. role.

SEL-7972 3

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). Weremoved the item from the known issues list.

• Site Grid

Chapter 3Deprecated Known Issues

3-34

Site Grid


Task completion details arenot displayed in CDA taskpopover window if the relateduser changes their emailaddress.

SEL-8145 4

Impact AnalysisThis section describes business and functional impact for Oracle Site Select release20.1.

Enhancement Enablement Setting Impact

Account Settings No configuration needed, thisis driven by user permissions.

Users can see this menu itemif they have a permission thatapplies to one of the items inthe Account menu, i.e.• Account data sources• Data source matches• Users and roles• Business partner

collaborator teams• Teams• Authentication and API

configuration

Branding N/A N/A

Business PartnerCollaboration

• Oracle admin user needsto enable businesspartner collaboration atthe account level betweenthe study owner and thecollaborator.

• Oracle admin user needsto add the collaborator tothe study owner's study.

• The collaborator userneeds 'Business partnercollaborator user'permission and needs tobe assigned to the studyowner's account.

• A collaborator user needsto be assigned to aCollaboration team underthe study owner's accountto view studies under thestudy owner's account.

The collaborator users (e.g.,CRO users) will see theirprimary account and study theowner's account (e.g.,Sponsor's account) under theAccount drop-down menu.

Pages impacted:Manage external collaborationteams page and ManageCollaborations page

Data Import

Discontinued records

N/A No impact unless customeruses feature.

Chapter 3Impact Analysis

3-35


Data Import

Relabeled "Last import date"

No configuration needed. Users who view the Accountdata source managementpage will see the column labelupdated to say 'LASTACTIVITY'

Data Import

Boolean default values

N/A No impact, behavior is asexpected and per specificationof defaults

Data Integration API N/A N/A

Digital Signature

Site initiated digital signaturetransaction

Document action modal

Workflow task configuration

Oracle Site Select LITEmessaging

• Oracle admin user needsto enable digital signaturefor the account in order tosee the digital signatureoption in the workflows.

• 'Allow digital signatureson CDA documents' isenabled by default fornew workflows. Users candisable this if they do notrequire digital signaturefor that workflow.

• Also, as part of theworkflow setup, the usercan select the defaultcounter-signer (ifapplicable).

• Users with the 'CDACounter-signer'permission will beavailable to be assignedas a counter-signer forthe document

Users setting up workflowshave the ability to enabledigital signature for the CDAdocuments, and will also havethe ability to set a defaultcounter-signer (if applicable).

Counter-signer is nowoptional.

Site users will be able toinitiate a digital signatureaction from directly withinOracle Site Select LITE.

Pages impacted:• Site workflow

configuration• Document approvals• Oracle Site Select LITE


Redesign

N/A N/A


Responsive design

N/A N/A


Single Sign On (SSO) for sites

N/A No impact unless used


Site user self-unlock

No configuration needed. Site users will not need tocontact Oracle support tounlock their account.

Pages Impacted:Oracle Site Select and OracleSite Select LITE login page.


Email-verified Oracle SiteSelect LITE account activation

No configuration needed. Sites users will have to verifytheir email before setting upthe password for their OracleSite Select LITE account.

Pages impacted:Verify your email to completeaccount creation

Site Communications N/A N/A


3-36


Site Profile N/A N/A

Site Selection N/A N/A


3-37

4Severity 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.You experience a complete loss of service.The operation is mission critical to thebusiness and 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, ordocumentation 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.

4-1

5Browser 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. Below arecurrent certified and supported browsers.

Certified browsers – Certified browsers undergo full testing for new features andregressions. Browser related issues found after release are prioritized for fixes infuture patches or releases.

Supported browsers – Supported browsers undergo focused testing on commonly-used pages. We also address all browser related critical and blocker issues thatoriginate in our applications.

Application Release Certified Supported

Oracle Site Select 20.1 Chrome and IE 11 Not applicable

Oracle Site SelectLITE

20.1 Chrome and IE 11 Edge and Firefox

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

5-1

6Revision History

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

Date Part Number Description

18May2020 F29584-05 Added hotfix 20.1.0.2(available for this release18May2020)

07May2020 F29584-04 Corrected Data Sourcesstability improvementdescription in 20.1.0.1 hotfixnotes

05May2020 F29584-03 Added hotfix 20.1.0.1(available for this release05May2020)

10Apr2020 F29584-02 General Availability releasenotes

30Mar2020 F29584-01 Pre-General Availability(Feature Brief) version

6-1

cloud service oracle® health sciences site select release ... · intermittently, feasibility...

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