Once a study is complete, we recommend performing the following actions:
1. Data & System Lock
Lock All Participants: Lock all study records to prevent further edits or data additions across the entire database.
Medical Coding Cleanup (if applicable): Archive any empty coded repeating data instances.
Disable Active Data Collection: Navigate to the study Settings tab and set the study status to 'Not Live'.
2. Data Archival & Export
Export Full Study Data: Generate and download a full copy of the study data to ensure the sponsor/investigator retains a complete, timestamped archive including:
Raw study data
Metadata
Full audit trail
3. User Access & Permission Management
Revoke Non-Admin Access: Remove access for all general users and non-administrative site staff.
Restrict Admin Rights: Study Admins should remain as the only active users, restricting their own permissions strictly to essential administrative rights:
View
Export
Manage Records
Manage Settings
4. Integration Decommissioning & Archival
Decommission Services: Notify your Project Manager or Castor Support to decommission the medical coding integration or external services.
Archive Study: Study Admins (with Manage Settings rights) can archive the study from the My Studies overview.
Note: Archiving removes the study from the default view for all users, preventing accidental access while allowing admins to locate or un-archive it if necessary.
5. Regulatory Compliance & Data Retention
Data retention aligns directly with Castor’s Quality Management System (QMS) policies:
POL-QISMS-04: Document Management and Data Retention Policy
SOP-SUP-03: Data Archival and User Deactivation Procedure
This workflow ensures full compliance with ICH-GCP E6(R2), FDA 21 CFR Part 11, and applicable local clinical trial data privacy regulations throughout the trial lifecycle.