Clinical Data Management News & Insights

Regulatory Considerations Expert Group reviews draft FDA Guidance

June 19, 2023

The ACDM Regulatory Considerations Expert Group have reviewed and submitted comments on the recent draft FDA Guidance: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers.

The guidance provides an overall overview about the most relevant key points to consider on the use of electronic systems, electronic records and electronic signatures in clinical investigations. It also provides recommendations regarding the requirements, under 21 CFR part 11, under which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

This guidance has been open for public consultation and the Regulatory Considerations Expert Group have provided feedback to the FDA on some points that may need further clarity, on behalf of the ACDM. The final guidance is expected to be released once the FDA have reviewed and agreed on implementation feedback received for the whole international clinical trials community.

The ACDM Regulatory Considerations Expert Group looks at providing guidance information on a number of areas surrounding regulations. If you are interested in joining, find out more here: https://acdmglobal.org/regulatory-considerations-dmeg/