# Archiving Studies

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][1] control access to and management of archived studies, data, and documents.


<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: This feature requires <a href="/en/lr/66651/">configuration by an Admin</a> before you can archive studies and study documents, access archived studies, and manage archived studies in your Clinical Operations eTMF Vault.</p>
    </div>
  </div>
</div>



## Archiving a Study {#archiving}

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_](/en/lr/8561/) state
  * All _Milestones_ related to the target _Study_ contain _Actual Finish Dates_

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: Vault can archive studies with related documents under legal hold. When archived, the documents remain under legal hold.</p>
    </div>
  </div>
</div>



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](/en/lr/34126/) 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_.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: <em>Inactive</em> sites (sites with no subjects enrolled) remain in the <em>Inactive</em> lifecycle state after the <em>Study</em> moves to <em>Archived</em>.</p>
    </div>
  </div>
</div>



### 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](/en/lr/23143/) 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 {#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](/en/lr/66651/#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](/en/lr/61542/) 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.

 [1]: #managing-archived-studies
