13 Business Partner Collaboration

Oracle Site Select business partner collaboration functionality uses a model in which the study owner account (e.g., sponsor) houses studies and the study owners then grant collaborators (e.g., CRO users) access to studies via collaboration team permissions.

An Oracle administrative user enables the partner relationship between the study owner and collaborator accounts. Please contact your Oracle Project Manager to discuss scheduling and business requirements.

Permissions

Oracle Site Select uses the following business partner collaboration user permissions to allow and restrict study and report access:

• Business partner collaborator user – A user in the collaborator account who can be assigned to a study owner's study
• Manage business partner collaboration users – For accounts set as a business partner collaborator, this permission allows for managing the users assigned the Business partner collaboration user permission to define to which study owners the collaboration users are available as a resource
• Manage business partner collaborator teams – A study owner user can define business partner collaboration team permissions for collaboration users on specified studies

Collaborator users

Collaborator users included in at least one collaboration team with study access will see an “Account” drop-down menu to the left of the "Study" drop-down menu. The menu lists the Oracle Site Select user’s “primary” account (e.g., the collaborator account to which the user authenticates) as well as the study owner account(s) to which the user has been assigned to a team with study access.

The Account drop-down menu allows the collaborator user to swap to assigned Oracle Site Select studies. When the collaborator user chooses:

• the “primary” collaborator account, the Studies drop-down menu includes only those studies to which the user is permissioned within the primary account, and teams and permissions granted to the user in the primary account remain in place
• a study owner account, the Studies drop-down menu includes only those studies the user is permissioned to access (as defined by the applied collaboration team(s) for the study owner account). A collaboration user entering a study owner's study loses all permissions and team assignments granted to the user from the primary account (because the study owner team controls permissions in the study owner account). Additionally:
  • A collaboration user assigned to a study owner's study and assigned to a site that has yet to be invited to the study will have their email address used as the reply-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 a reviewer for a CDA (when granted the appropriate permissions in the study owner's collaboration team), and this user receives all associated CDA negotiation emails.
  • A collaboration user assigned to a study owner's study can save a study and site level note (when granted the appropriate permissions in the study-owner's collaboration team). The user’s name will reflect in the note's record and in the audit log.
  • A collaboration user assigned to a study owner's study, assigned to a site, and granted the restriction of "View/manage assigned sites only" as a collaboration team from within the study owner's account, sees only the assigned sites in all site grids when viewing this study owner's study.

Note:

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

Report access

Study owners may allow collaborator users to access the study owner’s study level Site Progress reports in Oracle Site Analyze. Suppose the user has been added to a collaboration team that includes report access permission. In that case, the user will access the study owner report data using 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 their “primary” Oracle Site Analyze account – not the study owner's Oracle Site Analyze account.
• A user who has access to reports in their "primary" account can access Oracle Site Analyze and also see reports associated with the study owner’s studies (those which the user has been given Oracle Site Analyze access via a collaboration team) in addition to the reports for which the user is permissioned in their "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 study owner’s studies for which they are given Oracle Site Analyze access via a collaboration team. This user will not see reports for studies in their "primary" account.

Remove a business partner collaboration

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

• All collaboration users from that collaborator with access to the study owner's studies lose access
• All collaboration teams defined in the study owner's account are removed/deleted for that collaborator
• All study owner studies with that collaborator are toggled off for business partner collaboration and the chosen collaborator is removed/reset to blank
• If toggled back on, all collaboration teams, partnerships, modals, and chosen collaborators reset to blank
• The study owner is removed from the collaboration partner's drop-down menu of study owners