In Clinical Operations Vaults, using the Study Person object lets you leverage the flexibility of Dynamic Access Control (DAC) for documents without having to manually create hundreds or thousands of User Role Setup records. This feature automates the creation of User Role Setup records according to rules specific to your Vault. Using this feature, you can configure a system where Site or Country Managers easily maintain their own team rosters, supporting a quicker study startup process and easier upkeep.
To set up the feature:
- Enable DAC for any roles with which you’ll use this feature.
- Verify that the Study Team Role and Role Dependency objects include any fields used for matching on the User Role Setup object.
- Create Study Team Role object records.
- Optional: Create Role Dependency object records within each Study Team Role record.
- Set up access control for Study or Country Managers.
Note: This feature is only available on Clinical Operations Vaults.
Matching Object Field Setup
When setting up Study Person, the Study Team Role and Role Dependency objects must include any fields that the User Role Setup object uses for matching. If this isn’t the case, create new fields on these objects.
Note: You should not create new fields referencing Study, Study Country, and Study Site.
To define matching fields:
- Find fields on the User Role Setup object.
- Note the field names, for example,
- Navigate to the Study Team Role object configuration.
- Create new object fields corresponding to the fields on User Role Setup. Vault maps fields to each other using the field name, so the first part of the name (before the
__vsuffix) must match, for example,
document_type_group__von User Role Setup corresponds to
document_type_group__con Study Team Role.
- If you’re using role dependencies, repeat this process on the Role Dependency object.
Note that you can edit some Study Team Role record fields (Name, Description, Monitoring Visit Participant, and Link) even when they are referenced by a User Role Setup record.
The Study Team Role object records define the business role’s primary document role, while Role Dependency records define one or more secondary document roles. For example, Site CRA’s primary document role is Editor on documents for a specific study site. Site CRA has two role dependencies: (1) Viewer on documents for that site’s parent country and (2) Viewer on documents for that site’s parent study.
You can restrict the assignment of Study Team Roles based on Person Type and/or Security Profile. When you attempt to save a record, Vault performs validation checks to prevent users from creating Study Person records with disallowed combinations.
How to Set Up Study Team Roles
To set up records for Study Team Role:
- Navigate to the Study Team Roles record list page, usually from Admin > Business Admin.
- Click Create.
- Define a name for the Study Team Role.
- Select a Level for the role: Study, Country, or Site. When users create study team assignments, they’ll define a specific value at this level. For example, Site CRA uses Level = Site, so users setting up an assignment would select a study, study country, and site.
- Select an Application Role. When creating study team assignments, the user in the assignment would have the corresponding document role on documents that match at the defined level. For example, Site CRA uses Application Role = Editor, so users with that assignment would have Editor access on documents with the same site as their assignment.
- Optional: Select an Allowed Person Type for this role. If entered, Vault only allows users with this Person Type to be added to this role.
- Click Save.
Note: For security reasons, the maximum number of Study Team Roles allowed in a Vault is 300. If you attempt to create an additional Study Team Role and there are already 300 records in your Vault, Vault issues an error message and does not allow you to continue.
To set up records for Role Dependency:
- Under Role Dependencies, click Create. You should still be within the Study Team Role record that you just set up.
- Select a Level for the secondary role: Study, Country, or Site. When users create study team assignments, define a specific value at this level. Rather, Vault will use the related records. For example, Site CRA uses Level = Country for one of its role dependencies, so users setting up an assignment would select a site and Vault automatically knows the related country.
- Select a Target Application Role. When creating study team assignments, the user in the assignment would have the corresponding document role on documents that match at the defined level. For example, Site CRA’s role dependency uses Level = Country and Application Role = Viewer, so users with that assignment would have Viewer access on documents with the parent country of the selected site from their assignment.
- Click Save.
How to Set Up Security Profile Role Constraints
To set up constraints for a role based on a user’s Security Profile:
- Under Study Team Role Constraints, click Create. You should still be within the Study Team Role record that you just set up.
- Enter a Name.
- Select the desired Security Profile.
- Click Save.
Syncing Study Person with Principal Investigator
Optionally, you can Enable Sync PI Field with Study Person under Admin > Settings > Application Settings > eTMF Features. This feature allows Vault to update the Principal Investigator field of a Study Site record when a user creates a new Study Person for that Study Site with the Principal Investigator role. Likewise, it allows Vault to automatically create a new Study Person record for a Study Site if a user updates the Principal Investigator field to a Person for whom the Study Site does not already have a Study Person record.
If your organization wants Study or Country Managers to handle team assignments in Vault, those users need to be able to manage the Study Person records. In Vaults that don’t use custom security profiles, these users will need the standard Business Admin profile to create any object records, but we recommend using custom security profiles to provide more granular access control.
Start by copying the Document User profile and permission set to create a new Study Manager profile. Edit the new permission set to grant the following permissions:
- Object: Study Person: Create
- Object: Study Person: Edit
- Object: Study Person: Delete
Object Record Sharing
If you want to ensure that Study Managers can only create and edit assignments for their own studies, you can enable Dynamic Access Control on the Study Person and Study objects.