Why would you archive a study?

Global clinical trial regulations define requirements for retaining clinical trial documents (archiving). These regulations require that, at the conclusion of a study, relevant records and their audit trails must:

• Be retained for a period of up to 25 years (year requirement varies by region)
• Be protected from unauthorized changes
• Have “suitably restricted” access, yet be readily available for inspection purposes
• Provide for identification, version history, search, and retrieval

When should a study be archived?

A study should be archived once all work is finished and all study records are accounted for and complete.

Who can archive a study?

Research Organization and Site Administrators

Can I reverse an archived study back to active?

No, the archival process cannot be reversed.

Who can access an archived study?

Site Administrators retain access to studies in all statuses. Administrators can reactivate or create new Study Team or Monitor and Auditor assignments.

How long will SiteVault retain archived study data?

Per our Terms of Service, Veeva will retain all documents for at least 25 years regardless of the timeframe reflected in the Retention Period End Date field.

What happens when a study is archived?

See the Study Archival Automated Actions on the Study Archive Overview page.

Can I archive an individual document into an archived study?

In SiteVault, entire studies are archived, not individual documents. When a study document is found after archival or a document is unarchived for an update, the entire study is archived again to add it back to the archive.

The Archive Document action listed in a document’s All Actions menu is a system tool that is not used in SiteVault. This action can archive a document for a study that has not yet been archived, protecting the document by removing it from all users’ visibility. Should this action be selected in error, contact Site Support.

Can I use the Archive Document action in a document’s All Actions menu?

In SiteVault, entire studies are archived, not individual documents. When a study document is found after archival or a document is unarchived for an update, the entire study is archived again to add it back to the archive.

The Archive Document action listed in a document’s All Actions menu is a system tool that is not used in SiteVault. This action can archive a document for a study that has not yet been archived, protecting the document by removing it from all users’ visibility. Should this action be selected in error, contact Site Support.