Study Archive Overview | SiteVault Help

Note The Study Archive action cannot be reversed. A study in the Archived state cannot move to another state.

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:

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

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:

Component	Description
Study Status	The study status is changed to Archival in Progress during the archival process. If the archival system process fails to complete successfully, then the study will remain in this status and you should contact Support. The study status is changed to Archived once all system processing has been successfully completed.
Notifications	If an archival fails, Site Support will need to assist you. In this instance, the initiator and Site Support are notified. Site Support will complete the needed steps and request that you initiate the archival again. For more information, see Study Archive Failures.
Study Documents	All study documents are removed from the library and are only visible from the Study eBinder. When viewing a document in the Document Viewer, a file box icon displays next to the file name. All study documents become uneditable while in Archived or Archival in Progress statuses. Site Administrators can add a document to an archived study. For more information, see Add a Document to an Archived Study.
Study eBinder	Studies in the Archived or Archival in Progress states display their study status and Study End Date. The ability to upload to the study from the Study eBinder is removed.
Multi-Study Documents	Multi-study documents are associated with multiple studies within SiteVault and reflect these studies in the Study document field. Each version of each multi-study document associated with the study prompts a new, study-specific document with a new Document Number. This document is a snapshot of the original document. The original documents are available for review in the new document’s Relationship menu, and the original audit trail is attached to the new document. For more information, see Study Archive and Multi-Study Documents.
Note to File	A Note to File document is generated and added to the study. This document summarizes the archival process (ex. the initiator, time to process, document count, etc.). The document count included in the Note to File document does not include the Note to File document itself. For information on studies archived multiple times, see Rearchive a Study.
Study Participants	All Participants are removed from the study. New Participants cannot be created.
Study Team Assignments	All members of the Study Team are moved to the Inactive state. New Study Team Assignments can be created, and existing assignments can be reactivated.
Monitors and Auditors	All Monitors and Auditors are moved to the Inactive state. New Monitors and Auditors can be created and existing assignments can be reactivated.
Study Organizations, Products, and Responsibilities	Cannot create new Organizations, Products, or Responsibilities.
Monitoring Issues	Any open Monitoring Issues are canceled.
eConsent	eConsent cannot be enabled.
Digital Delegation	Digital Delegation cannot be enabled.