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 in an active workflow
- No documents related to the target Study are unclassified
- No documents related to the target Study are in the Planned state
- All Milestones related to the target Study contain Actual Finish Dates
Note: Vault can archive studies with related documents under legal hold. When archived, the documents remain under legal hold.
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
- Vault archives all documents associated with the Study at the time the archival job runs
- 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
When you archive studies that include documents reused across multiple studies, Vault creates study-specific, uneditable snapshot copies of those documents and archives only the copies. The original documents remain in your Library where active studies can continue to use them. Any updates to the Library versions will not affect the archived copies.
The snapshot includes:
| Component | Snapshot Behavior |
|---|---|
| Source File & Versions | Copies the source file and all document versions where the Study field includes the study being archived. |
| Lifecycle & Doc Type | Snapshot copy version maintains the Lifecycle State and Document Type from the original document. |
| Renditions | Copies all document renditions from the original document. |
| Metadata | Copies all metadata from the original document, excluding system fields. |
| Relationships | Recreates outbound document relationships from the original document onto the snapshot copy in addition to a relationship to the original parent document. |
| Attachments | Recreates the attachments from the original document on the new corresponding snapshot version of the document. |
| Audit Trails | Copies the audit trail of the original document and is made available as a standard rendition labeled “Historical Audit Trail”. Snapshots of placeholders do not include audit trails. |
| Sharing Settings | Recreates original documents Sharing Settings, including manual role assignment access. |
On the snapshot copy of the document, the Archive field is set to Yes and the Study field on the snapshot includes only the archived study value. Vault removes the archived study from the Study field on the original document.
Archiving CrossLinked Documents
If the study contains CrossLinked documents originating in another Vault, Vault creates snapshot copies of those documents during archival. This snapshotting process automatically applies to documents where the Crosslink field is set to Yes. The original CrossLinked document remains in the Library.
CrossLinked documents with a single Study value on the latest version keep the Study-related reference fields when Vault creates a snapshot. Vault creates the snapshot copy as a regular document, not a CrossLink document, and only populates the Study field with the archived study. This allows Vault to remove the archived study value from the Study field on the CrossLinked document in the Library without creating a new document version.
Once a user archives a Study, Vault deletes CrossLinked documents from the Library when only the archived Study is tagged across all versions of the document. This prevents orphaned documents once snapshots copies are archived.
Once Vault archives the study, the archived snapshot does not reflect changes made to the document in the other Vault.
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.