Archived Studies Access

Archived studies remain accessible to Site Administrators at all times. Site Administrators can grant access to those who need to review or audit an archived study.

Site Administrators can make the following access changes:

• Reactivate or create new Study Team Assignments, allowing site staff to review study details in preparation for an audit.
• Reactivate or create new Monitor and Auditor Assignments, granting the audit team access to the archived study in the Study eBinder.

Original Document Audit Trails for Multi-Study Documents

Multi-study documents are documents associated with more than one study. During the archival process, SiteVault copies each version of a document associated with the archived study and creates new, study-specific ‘snapshot’ documents for each version.

To assist with the audit process, the original documents are listed in the new documents’ Relationship menus, and the original audit trails and eSignatures are attached to the new documents in Document Files > Renditions. For more information on multi-study documents see Study Archive and Multi-Study Documents.

Archived Studies Reporting

When creating a Document report, users have the option to base the report on documents for archived studies only. To use this option, select Archived Documents from the Document Scope section.