Archiving is the process to initiate the long-term storage of the essential documents following the completion of a clinical research study. Use the following checklist to ensure that your study is ready for archival:
Study Tasks and Workflow: Run reports to ensure that all study tasks and workflows are complete.
- Study Documentation:
- Check for any draft documents in the library that may need to be finalized in order to add to the eBinder.
- Ensure that the eBinder contains all essential documents.
- Ensure that all essential documents have been monitored and have a Monitoring Status of Complete (No Issues).
Study Participants: If applicable, run reports to ensure that all participants are no longer active on the study.
Partner Organizations: Set all partner organizations to Inactive.
External Users: Set all study monitor assignments to Inactive.
Products: Set all study products to Inactive.
- Study Team Assignments:
- If not using Digital Delegation, set all study team members to Inactive.
- If using Digital Delegation:
- Archive Study:
- Set the state of the study to Archived.
- If you’re a SiteVault Enterprise customer with the Vault Archive feature enabled and configured for your vault, move the study-specific documents to the Vault Archive.
- Export Study Documentation: If applicable, export study documents per your site’s record-keeping SOPs.