Configuring for Study Archival (eTMF)

Vault supports the one-click archiving of studies, including study documents, TMF-related objects, and audit trails, to allow for supervision after a clinical trial is complete. This feature requires some configuration before users can archive studies and access archived studies.

Configuration Overview

• Contact Veeva Support to enable Study Archival in your Vault. Note that this also enables the Lifecycle for Study, Study Country, and Study Site feature. If this feature is not already enabled in your Vault, you will need to complete additional configuration to manage TMF objects with lifecycles.
• Optional: Configure the Initiate Study Archival user action on appropriate Study object types.
• Configure the Initiate Study Archival user action on relevant Study lifecycle states.
• Configure Atomic Security for the Initiate Study Archival user action on the Study object.
• Configure cascading archive from Study Countries to Study Sites.
• If applicable, remove legacy archival configuration.
• Grant archival-related permissions to the appropriate users.

The Initiate Study Archival user action is automatically available on the Closing lifecycle state of Studies for users with the Manage Archive permission but can be configured on other states.

Configuring the Initiate Study Archival User Action

You can configure the Initiate Study Archival user action on specific types of the Study object:

1. Navigate to Admin > Configuration > Objects > Study > Object Types.
2. From the Object Types tab, click Actions.
3. From the Actions menu, click Edit Object Type Actions.
4. Select the checkboxes to assign the Initiate Study Archival user action to specific object types.
5. Click Save.

Study Object Types

You can configure the Initiate Study Archival user action on specific types of the Study object. We suggest using Initiate Study Archival for the Action Label.

Study Lifecycle States

Configure the Initiate Study Archival user action on all applicable Study Lifecycle states. We suggest using Initiate Study Archival for the Action Label.

Atomic Security for the Study Archival Action

You must configure Atomic Security for the Initiate Study Archival user action on the applicable Study Lifecycle states so that only the appropriate users can access the action:

1. Navigate to Admin > Configuration > Object Lifecycles > Study Lifecycle > States > and click on the applicable state in the States section.
2. In the Atomic Security: Actions section, click Edit.
3. Set the default State Behavior to Hide for the Change State to Archive and Initiate Study Archival actions.
4. To allow your archivists to execute the Change State to Archive and Initiate Study Archival actions, click + Role Override.
5. In the dialog, select the appropriate Application Role and click OK.
6. Set the override behavior for the Change State to Archive and Initiate Study Archival actions to Execute for the archivist role.
7. Navigate to Admin > Configuration > Object Lifecycles > Study Lifecycle > States > Archived and click Edit in the Atomic Security: Actions section.
8. Set the default State Behavior to Hide for the Re-activate Study action.
9. To allow your archivists to execute the Re-activate Study action, click + Role Override.
10. In the dialog, select the appropriate Application Role and click OK.
11. Set the override behavior for the Re-activate Study action to Execute for the archivist role.

Transitioning to the New Study Archival User Action

1. Navigate to Admin > Configuration > Objects > Study > Actions > Initiate Study Archival (archive_study__v) and click Edit.
2. Update the Label to “Initiate Study Archival (Legacy)” to easily differentiate it from the new Initiate Study Archival user action and click Save.
3. Configure the new Initiate Study Archival user action on all applicable Study Lifecycle states.
4. Configure the new Initiate Study Archival user action on appropriate Study object types.
5. Copy any existing Atomic Security configurations on the Initiate Study Archival (Legacy) user action to the new Initiate Study Archival user action.
6. Navigate to Admin > Configuration > Objects > Study > Actions > Initiate Study Archival (Legacy) and click Edit.
7. Change the Status to Inactive and click Save to inactivate the legacy user action.
8. Navigate to Admin > Settings > Application Settings and click Edit.
9. In the eTMF Features section, set the Enable Archive Study from Any State option and click Save to enable the new Initiate Study Archival user action. Note that when you enable this feature, Vault will automatically hide the Initiate Study Archival (Legacy) user action from all Study object types and lifecycles, so make sure you have already copied over all Atomic Security configurations to the Initiate Study Archival (archive_study_all_states__v) user action before completing this step.
10. Configure the new Initiate Study Archival on the appropriate Study object types and lifecycle states.

Configuring Cascading Archival from Study Country to Study Site

You can configure your Vault to automatically archive Study Sites when the associated Study Countries move to the Archived lifecycle state. Note that you must do this for Vault to archive Study Sites and Study Countries when the archival job runs:

1. Navigate to Admin > Configuration > Object Lifecycles > Study Country Lifecycle and click on the Archived state in the States section.
2. In the Entry Actions section, click Edit.
3. Click Create Entry Action.
4. Select Change related object lifecycle state from the actions dropdown menu.
5. For Related Object, select Study Sites.
6. For Change State To, select Archived.
7. Set the Conditions on Related Records checkbox.
8. For Condition, select Exclude related records in the following lifecycle states.
9. For Related Record’s State, select Not Selected
10. Click Save.

Removing Legacy Archival Configuration

If your Vault includes existing configurations or business processes that have helped you to archive content before enabling the Study Archival feature, we recommend reviewing those configurations and removing them where they are no longer applicable. For example, an “archived” document lifecycle state and supporting archival workflow and business processes.

Related Permissions

Users can complete all steps in this article with the standard Business Admin, System Admin, or Vault Owner security profile.

If your Vault uses custom security profiles, your profile must grant the following permissions:

Type	Permission Label	Controls
Security Profile	Application: Search: Manage Archive	Ability to execute the Initiate Study Archival action on Study records, upload documents to archived studies, create new records associated with archived studies, and edit metadata for archived studies.
Security Profile	Application: Search: View Archive	Ability to view archived documents. Note that users with View permission must also have a role on the archived document to view the document.
Security Profile	Objects: Study: Object Action Permissions: Initiate Study Archival: View	Ability to view the Initiate Study Archival action on Study records.
Security Profile	Objects: Study Archival Initiation: Read, Create, Edit, Delete	Ability to execute the Initiate Study Archival action on Study records. Note that this permission only applies to the legacy Initiate Study Archival (archive_study__v) user action.
Security Profile	Tabs: Archive: View	Ability to access the Archive tab.