Part 3: What’s Possible with Certified Copies of Source Data?

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… Read More

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