Note Sites should decide based on their internal processes and agreements with sponsors or contract research organizations (CROs) what type of source documents and information to store and share in SiteVault.
You can use SiteVault to store and maintain source documents and make them available to monitors for review.
- Source Documents Definition: “All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).” - ICH Guideline for GCP
- Certified Copy of a Document Definition: “A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original.” - ICH Guideline for GCP
- Performing Copy Certification: You can use SiteVault to perform Copy Certification on source documents. For more information, see Copy Certification of Documents.
- Source Document Lifecycles: Source documents in SiteVault follow the Draft to Current - Source and Draft to Final - Source lifecycles.
- Editing Source Documents: Once finalized, only Site Administrator users can edit the fields on source documents.
Monitor Review Workflow
The following flowchart illustrates the site and monitor review workflow:
SiteVault
