Regulatory Considerations Expert Group reviews draft FDA Guidance
Date: 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/
Explore More News
Welcome The Institute of Cancer Research – Scientific Computing as a corporate member
The Association for Clinical Data Management (ACDM) is delighted to welcome The Institute . . .
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are as essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
