What each study role can do
Each person on a study has one role, chosen when they are invited. The role decides which pages they see, what they can change and whether they can see treatment arms. Site roles also need to be assigned to one or more sites.
The roles
| Role | What it is for | Needs a site? |
|---|---|---|
| Study Owner | Full control over study settings and the team. Blinded, and does not enter clinical data. | No |
| Study Manager | Runs study operations across all sites: settings, team and sites. | No |
| Administrator | User accounts, role assignment and training records. Blinded, with no clinical data access. | No |
| Trial Manager | Operational oversight: read-only on set-up, but can run reports, queries and exports. | No |
| Data Manager | Data quality: reports, exports, queries, freezing and locking data. | No |
| Sponsor | Sponsor representative with view-only, blinded access. | No |
| Medical Monitor | Safety oversight, with access to unblinded data. | No |
| Pharmacovigilance / PV + MedDRA Coder | Adverse event monitoring and reporting; the combined role also codes events with MedDRA. | No |
| Medical Coder | Codes verbatim terms to MedDRA. Blinded, with no access to personal details. | No |
| Lab Manager | Manages lab reference ranges and reviews lab data. | No |
| Translation Manager | Manages translations of questionnaires and participant-facing text. | No |
| CRA | Monitors assigned sites and verifies source data. | Yes |
| Principal Investigator | Medical oversight and sign-off at the site. | Yes |
| Sub-Investigator | Clinical assessments at the assigned site. | Yes |
| Study Coordinator | Enrollment and data entry at the site. | Yes |
| Pharmacist | Dispensing, returns and destruction records for study drug at the site. | Yes |
| Unblinded Administrator | Maintains the unblinded kit list and randomization list. Kept apart from the blinded team. | No |
| Unblinded Statistician | Unblinded exports and analysis datasets; can prepare the randomization and kit lists. | No |
| Depot Manager | Depot inventory, shipments and supply accountability. | No |
| Read-Only Auditor | Views all data for a regulatory audit. | No |
Blinded and unblinded roles
Most roles are blinded: they never see a participant's treatment arm, block sizes or the randomization list. Only the Unblinded Administrator, Unblinded Statistician, Medical Monitor and Depot Manager see that information. Read what blinding hides for the details.
See exactly what a role can do
Open Settings > Team.
Click ⋯ on the person's row and choose View Permissions.
You see their role, whether it needs a site, and every permission grouped by area.
Questions
Can a Study Owner enter data or randomize participants?
No. The Study Owner manages the study but, to keep duties separate, cannot enter or edit clinical data, randomize, dispense study drug or unlock data. Site roles and data managers do that.
Who can give someone the Study Owner role?
Only a Study Owner. Other team managers can only give roles whose access they already hold themselves.
Can I give someone temporary access?
Yes. Set Access until when you invite them, or later with Set Access End Date. Their access ends automatically after that day.
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