Let’s do a quick compare and contrast between FDA and GCP definitions to understand better what is possible with Source Data.

Critically, both definitions address changes from paper to electronic; FDA in a specific parenthetical, and GCP in a general sense about “type of media used.” They both care about having the same information verified, though FDA requires a dated signature, whereas GCP allows “a validated process.”

So, what does this mean?

One common practice that falls apart under this analysis is the wholesale printing of EHR records. Unless EHR records are being certified after printing, they don’t fall under the definition of Source Data asserted under FDA guidance or GCP. Uncertified EHR printouts are not valid source.

Another implication is that electronic Certified Copies are valid source. For example, if you were to scan a paper-originated source document and then certify it with a Part 11 compliant signature process, you would have a regulatory-compliant clone. If a monitor could access that source remotely, it would be EXACTLY AS IF they were on site. It also means that entire studies could be digitized, certified, and compliant with record retention requirements.

How are you using Certified Copy?


This post is part of our series,  “Using Certified Copy in a Clinical Trial”.
Posts in this series:
Part 1: The Paper Problem
Part 2: What is Certified Copy?
Part 3: What’s Possible with Certified Copies of Source Data?

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