Vault supports the one-click archiving of studies, including study documents, document audit trails, and study-related records after a clinical trial is complete. User permissions control access to and management of archived studies, data, and documents.
Note: This feature requires configuration by an Admin before you can archive studies and study documents, access archived studies, and manage archived studies in your Clinical Operations eTMF Vault.
Archiving a Study
Select Initiate Study Archival from the Actions menu of a Study that fits the following criteria:
- No documents related to the target Study are checked out
- No documents related to the target Study are under legal hold
- No documents related to the target Study are in an active workflow
- No documents related to the target Study are unclassified
- All Milestones related to the target Study contain Actual Finish Dates
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
- EDLs, EDL Items, and Milestone Items move to Inactive
- The following study-related records move to Inactive:
- Metrics
- Metrics Over Time
- Procedure
- Procedure Definition
- Site SAE Tracking
- Study Site Location
- Subject
- Subject Visit
- Visit Definition
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.
Note: Inactive sites (sites with no subjects enrolled) remain in the Inactive lifecycle state after the Study moves to Archived.
Re-Archiving a Study
You can re-archive a study by moving it back to the Closing state and re-executing the Initiate Study Archival action. This may be helpful if a large number of documents or records were created since the Study was archived or if the archival job encountered errors and did not fully complete.
Archiving Documents Reused Across Studies
Vault creates study-specific snapshot copies of all documents used across multiple studies and archives only those copies. The snapshot copy is archived and the original document remains in your Library. The snapshot includes:
- The source file
- Relevant document versions
- The source document audit trail
- All metadata except system-managed fields that Vault populates for each document
The Study field on the snapshot copy includes only the archived study. Vault removes the archived study from the Study field on the original document. Note that snapshots of placeholders do not include audit trails.
Archiving CrossLinked Documents
If the study contains CrossLinked documents originating in another Vault, Vault creates snapshot copies of those documents at the moment of archival. The snapshot is not a CrossLink and so does not reflect changes made to the document in the other Vault after the study is archived.
Managing Archived Studies
View Archive Permission
Users with the View Archive permission can view archived documents and see archived studies in Study picklists. However, they cannot create new references to archived studies via an object record or document, nor can they edit archived documents.
Manage Archive Permission
Users with the Manage Archive permission can add, change, and delete references to archived studies via an object record or document. You can’t edit archived documents but can unarchive a study by reactivating it from the study’s Action menu so that you can edit the study documents. You must have this permission to edit records related to archived studies.
The following study-related records require the corresponding View Archive, or Manage Archive permission to view and/or edit the object records respectively:
- Agreement
- Central Monitoring Event
- Clinical Trial Notification / 治験届
- Clinical User Task
- CTN Data / 治験届関連情報
- CTN Data Change Log
- CTN Site IP/ 治験施設治験薬情報
- Distribution Task
- Enrollment Status Log
- Expected Document
- Expected Document List
- Fee
- Fee Schedule
- Fee Schedule Template
- Fee Template
- Informed Consent Site Effective Tracking
- Informed Consent Tracking
- Issue
- Metrics
- Metrics Over Time
- Milestone
- Monitored Informed Consent Form
- Monitored Metrics
- Monitored Subject
- Monitored Subject Visit
- Monitoring Compliance
- Monitoring Event
- Payable Item
- Payee Override
- Payment Request
- Procedure
- Procedure Definition
- Response
- Review Comment
- Selected Site
- Site Fee
- Site Fee Definition
- Site SAE Tracking
- Study
- Study Arm
- Study Communication Log
- Study Country
- Study Organization
- Study Person
- Study Product
- Study Site
- Study Site Location
- Study Team Assignment
- Subject
- Subject Visit
- Template EDL
- Template Expected Document
- Trip Report Question Response
- Trip Report Template
- User Role Setup
- Visit Definition
Unarchiving Studies
Users with the Manage Archive permission can unarchive a study by reactivating it from the study’s Actions menu so that you can edit the study documents. Note that an Admin must configure Atomic Security in order for users to perform this action.
Accessing Archived Documents via the Study Person Object
Users with the Manage Archive permission can create Study Person records for archived studies to enable access to archived documents.
Limitations
Though you can perform individual steps to undo specific parts of the Study Archival process, there is no singular action to reverse them all at once. We recommend establishing business processes for your organization to ensure that studies are archived appropriately.