Closing a study is a multi-step process designed to secure your data, finalize the audit trail, and prevent any new consenting activities.
Follow these steps to ensure a compliant study wrap-up:
1. Stop New Participant Enrollment
Before archiving data, you must ensure no new participants can be invited.
Deactivate Recruitment Links: If you are using a public enrollment portal or landing page reach out to Castor Support and request deactivation
Notify Sites: Communicate with all site investigators to ensure they have stopped sending manual email invitations.
2. Archive Consent Forms
To prevent any further signatures on active documents:
Navigate to the 'Consent forms' tab.
Locate your active ICFs.
Click the three dots menu (Options) and select 'Archive'.
Note: Once a form is archived, it cannot be un-archived, so ensure all pending signatures are collected first.
3. Finalize Participant Records
Ensure the status of every participant is accurately reflected for the final audit trail.
Check Pending Signatures: Follow up on any "In Progress" statuses.
Withdraw or Archive: For participants who did not complete the study, use the 'Mark as withdrawn' or 'Archive' options in the Participant list to update their status.
4. Export Final Data & Audit Trails
Per regulatory requirements (such as 21 CFR Part 11), you must maintain a copy of the audit trail.
-
Export Audit Trail:
Go to the 'Audit trail' tab
Use the 'Export' button to download a full CSV/Excel log of every action taken in the study.
Download Signed Documents: Ensure all signed ICFs are exported.
5. Revoke User Access
Once data is exported and the study is finalized:
Navigate to 'Users & Roles'.
Manage existing users and revoke access for site staff who no longer require entry.
Retain a "Read-Only" or "Study Admin" role for a central coordinator if long-term platform access is required.
6. Switch the Study Status
- For this request please contact Castor Support, once all the steps from above have been completed.