Background

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:

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

SiteVault’s archival process meets the above requirements and can serve as an electronic archive for clinical research sites.

Study Archive Timing

A study should be archived once all work has been completed and all study records are accounted for.

Accessing 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.

Retention Timeframe

When an Administrator initiates an archival, they are required to complete the End of Study Date field. They can also complete the Retention Period field, which defaults to the maximum of 25. These fields generate the Retention Period End Date, which is the End of Study Date + the number of years reflected in the Retention Period field. The Retention Period End Date can be used by your organization to identify studies that can be fully deleted from SiteVault (contact Support for more information). 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.

Study Archival Automated Actions

The Study Archival action is comprised of automated study status checks and several attestations that the action initiator (Site Administrators) must complete. Once the action is initiated, the following study components are affected: