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:

1. Study Tasks and Workflow: Run reports to ensure that all study tasks and workflows are complete. Include tasks such as eSignatures or training tasks.
2. 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.
3. Close Out Visit is Completed by Monitor:
   • Ensure that all essential documents have been monitored and have a Monitoring Status that indicates that a review is not required and/or there are no open issues. Note that Organization and Person Profile documents such as CVs or Medical Licenses will not have a Monitoring Status.
4. Supersede Documents:
   • Once the Monitoring Status indicates that review is not required and/or there are no open issues, the document can be moved to the Superseded state to remain consistent with the study status.
   • This should not be completed for any Organization and Person Profile Documents.
   • If using Digital Delegation, the document will automatically update when the study team assignments are updated to inactive and the PI approves.
5. Study Participants: If applicable, run reports to ensure that all participants are no longer active on the study.
6. Study Organizations: Set all study organizations to Inactive.
7. External Users: Set all study monitor assignments to Inactive. This should be done after the closeout visit as monitor assignments in the Inactive state will not be able to access documents to complete review.
8. Products: Set all study products to Inactive.
9. Study Team Assignments:
   • If not using Digital Delegation, set all study team members to Inactive.
   • If using Digital Delegation:
     • Except for the PI, set all study team members to Inactive.
     • Set all study responsibilities to Inactive.
     • Send inactive assignments to PI for approval.
     • Once approved, set the PI to Inactive on the study.
     • Ensure that the Delegation of Authority (DOA) document has been monitored.
10. Archive Study: Set the state of the study to Archived.
11. Export Study Documentation: If applicable, export study documents per your site’s record-keeping SOPs.