US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.

US FDA is updating its guidelines on compliance to "Part 11" electronic signature and record rules for clinical trials to catch up to today's technology, but the agency emphasizes in new draft guidance that it will maintain its "narrow and practical interpretation" of the rules, including continued enforcement discretion in certain areas.

The agency issued a draft guidance June 20 to update from a 2003 guidance interpreting the...

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