Clinical Basics: eTMF supports the one-click archiving of studies, including study documents, document audit trails, and study-related records after a clinical trial is complete.
Archival Reports
Before you archive a study, run several reports to check the status and completeness of all components of the study.
TMF Archival: All Documents: Check for completeness by ensuring that all expected documents have been uploaded to the TMF.
TMF Archival: All Unapproved Documents: Check for any documents that may still need to be approved prior to Archival.
TMF Archival: All Open Quality Issues: Locate any Quality Issues that need to be closed prior to Archival.
Unclassified Documents: This report shows all documents that have not yet been classified for a given Study.
Archive a Study
Select Initiate Study Archival from the Actions menu of a Study that fits the completeness criteria.
If all study documents and milestones are valid, Vault initiates the archival job and makes the following updates:
- The Study, its Study Countries, and its Study Sites move to the Archived lifecycle state
- All study documents are archived
If you attempt to Initiate Study Archival for a Study that does not meet all requirement criteria, Vault will notify you with an overview of the blocking issues.
If a Study Site closes before a Study, move the site to the Closed state. You can add new content to binders when a Study Site is closed because the Status is still Active.
Unarchiving Documents
Clinical Admins can unarchive a document by reactivating it from the study’s Actions menu.