As we talked about in part 1 of this blog series, paper presents an ongoing source data monitoring challenge, especially for multicenter clinical trials. Certified Copy exists as a regulatory mechanism by which we can replace paper records with electronic ones – or prevent them from being printed at all. To understand HOW, let’s examine this where it begins: at the source (literally).

FDA’s guidance Electronic Source Data in Clinical Investigations defines “Source Data” as: “All information in original records and certified copies of original records of clinical findings, observations, or other activities (in a clinical investigation) used for the reconstruction and evaluation of the trial. Source Data are contained in Source Documents (original records or Certified Copies).”

Interesting! We knew this about source, but that mention of Certified Copies? Intriguing.

What about ICH-GCP? E6 R2 defines “Source Data” as: “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).”

Again, we find a mention of certified copies! Double intriguing.

What is “Certified Copy”? According to FDA guidance, such as Electronic Source Data in Clinical Investigations, Certified Copy is defined as: “A copy (paper or electronic) of original information that has been verified, as indicated by a dated signature, as an exact copy, having all of the same attributes and information as the original.”

Or, if we examine the addenda to ICH-GCP E6 R2, we find that a definition of Certified Copy has been added: “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.”

Looking at this, we know that Source Data is valid as a Certified Copy. Very interesting!


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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