FDA Title CFR 21 Part 11 outlines expectations for use of digital signatures and electronic data capture and storage in place of paper based documentation and “wet signatures.” The intent of CFR 21 Part 11 is to increase confidence in the security, authenticity, integrity, and validity of data that is submitted to the FDA. Part 11 typically applies to FDA-funded drug and device studies; however, there are a number of considerations when trying to determine if Part 11 requirements must be met for an investigator-initiated trial. Meeting Part 11 requirements involves a much higher degree of clinical trial planning and resourcing in order to review and validate electronic systems and to develop and document compliant study processes and procedures. Ultimately, study teams needing to meet Part 11 requirements will need to work closely with institutional clinical research leadership when taking on these more intensive regulatory responsibilities.
The Trial-CARE Part 11 Services Unit is available to meet with investigators to discuss their study, determine the need for Part 11 compliance, and provide overall project management services or other support, if needed.
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