As you add documents to SourceDrive, you can upload them as “Certified Copy”.
What is Certified Copy?
When certifying documents in SourceDrive, you attest that the source document is an exact copy, having all of the same attributes and information as the original. SourceDrive requires this statement with your electronic signature to comply with FDA regulations in 21 CFR Part 11. Once certified, this digital copy is viewed as equivalent to the original source and source data verification can be performed against the certified copy. For this reason, it's recommended that all subject-related documents are uploaded as a certified copy.
Certification is on by default, but you can override this and upload a document without certification if you wish. To do so, simply click the "Certified Copy" toggle to slide it to the off position. The toggle should appear grey. This toggle is on (and colored teal) by default.
Certifying a Document on Upload
- Upload the document(s) and leave the "Certified Copy" toggle on.
- When you upload as Certified Copy, you will see an additional screen where you are asked to certify and electronically sign a statement that the document you are uploading is an unaltered document.
To save time, you can upload multiple documents and certify them all in one signing action:
If you agree with the statement, enter your PIN, a four-digit number. If you have not yet set your PIN, have forgotten it, or wish to revoke your previous PIN, use the “Request PIN email” link.
- Click “Certify” to complete the upload and certify workflow. Per FDA, this document would not be now an equivalent to the original.
If you did not mean to certify this document, before clicking "Certify" you can always click “Edit Selections” to go back to the edit details step and turn the certification toggle off.