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At long last — Draft FDA guidance on Part 11 compliance

The Food and Drug Administration, continuing its long tradition of issuing timely guidance, has issued a draft guidance about 21 CFR Part 11 — the regulation pertaining to the use of electronic records and electronic signatures in clinical investigations. A summary of the draft guidance is available here.

The comment about “timely guidance” should be read using the sarcasm font. This draft guidance relates to a final rule published in 1997 (yes, 20 years ago). Draft guidances and a policy document pertaining to that rule have previously been published, but were withdrawn in 2003, with the FDA announcing in August of that year that it would “reexamine” part 11. Thirteen lightning-quick years later, we finally have updated draft guidance. Just think about how much the technology this rule and guidance adress has changed in that time. Remember the smartphones we carried back in 1997 and used to transmit medical information? No? We don’t either, now that you mention it. Oh, that’s because there were no smartphones in 1997.

But we digress. Paper clinical trial records are quickly going the way of the dinosaur, or of paper IRB records. Investigators involved in FDA-regulated research will have to become familiar with FDA requirements pertaining to electronic recordkeeping. Note that the FDA will accept comments on the draft guidance through Aug. 21.