Study Personnel
A Study Person record attaches a Person to a study (and optionally a country/site), with a Study Team Role and start/end dates. The study team is the source of study contacts and drives role-based expected-document generation.
Create from Admin Setup → Study Personnel:
| Field | Notes |
|---|---|
| Person | The person (required); pick from the global directory or create inline |
| Full Name | Filled in automatically |
| Study | The owning study (required) |
| Study Country / Study Site | Cascading study → country → site selection |
| Study Team Role | Team role (required), e.g. Study Manager, Contributor, CRA |
| Grant Access to Related Records | When checked, the system creates a User Role Setup record granting access to related records |
| Start / End Date | Assignment dates |
Note
Checking Grant Access to Related Records is the key step that lets team members actually open study data; without it the person is registered as a contact only.
Role changes drive role-based expected documents: the Expected Documents section on the detail page shows the EDL Items generated for that role. Common actions:
| Action | Purpose |
|---|---|
| Create Study Contact (and In Bulk) | Quickly create study contacts |
| Resend Study Invitation (and In Bulk) | Resend the study invitation |
| Make Inactive | Remove the person from the team (history kept) |
| Retrigger EDL Item Creation | Regenerate expected documents after a role change |
User Role Setup
User Role Setup (URS) is a system-managed record-level security object: one record represents "this user has this role in this study/country/site context". It is usually created automatically — for example when Grant Access to Related Records is checked on a Study Person; administrators review and maintain it under Admin Setup → User Role Setup.
| Field | Notes |
|---|---|
| User | The granted user |
| Role | The granted role (e.g. study_manager, contributor) |
| Study / Study Country / Study Site | The scope, cascading |
| Blinding | Blinding scope (e.g. Blinded / Unblinded) |
| Name | Auto-numbered: DAC-{######} |
Note
URS underpins Vault record-level security (dynamic access control). To change team access, adjust the Study Person's Grant Access and role rather than hand-editing URS records.
Troubleshooting
| Symptom | Suggestion |
|---|---|
| Team member can't see study data | Confirm Grant Access to Related Records is checked and the team role matches study sharing |
| Expected Documents section is empty | The role hasn't triggered generation; run Retrigger EDL Item Creation |
| Odd URS records | They are system-maintained in most cases; verify Grant Access and role setup before editing manually |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Study Person: Create, Read, Edit | Maintaining the study team and contacts |
| Object actions | Study Person: Create Study Contact, Resend Study Invitation, Retrigger EDL Item Creation | Contacts, invitations, expected-document generation |
| Object | User Role Setup: Read (Create, Edit) | Viewing (managing) record-level grants |
Clinical Application Administrator fully manages Study Personnel and URS; Document Contributor is read-only on Study Personnel.