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

SiteVault provides the option for finalized documents to be classified as certified copies. It is up to the site/organization to determine which documents are required to be certified copies. A document is considered a copy of source if it has been downloaded from an electronic source or electronic health record (EHR) system or if it has been scanned before being uploaded to SiteVault. A document is considered an original source document if this is the file where the data was originally captured (for example, if a .DOCX file was completed during the visit).

Step 1: Create a New Draft

A finalized document can be certified as a copy by creating a new draft, and then certifying the document as a copy during finalization

1. Access the document in the Document Library.
2. From the All Actions menu, select + Create Draft.

   

3. Select the file creation method.

   

4. Optionally, provide a description.
5. Select Create.

Step 2: Finalize and Certify as Copy

1. Access the document in the Document Library.
2. From the All Actions menu, select Change Status to {XXXX}, where XXXX is the document type’s final status.

   

3. Select a Document Date.
4. Optionally, provide a description.
5. From the Additional Actions dropdown, select Perform Copy Certification.

   

6. Select Save.