The JNPMEDI Global Research Center distributes the "Electronic Systems, Electronic Records and Electronic Signatures in Clinical Investigations Questions and Answers." of the U.S. Food and Drug Administration(FDA)'s guidance in Korean.
This guidance includes 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.
And also, this guidance addresses the applicability of 21 CFR Part 11 requirements for electronic systems and information technology (IT) services used to create, modify, maintain, archive, retrieve, or transmit an electronic record as well as for the use of digital health technology (DHT) to remotely acquire data in a clinical investigation.
Based on this guideline, JNPMEDI expects that the evolving uses of electronic records, electronic systems, and electronic signatures in clinical investigations is important for FDA and other regulators in its assessment of the authenticity, integrity, and reliability of data submitted in support of marketing applications or submissions.
Comments and suggestions regarding this draft guidance will be collected within 60 days of publication by the FDA.
This document can be downloaded in the link as below: https://mvn.do/translations/2023-03-fda-eclinical-systems-qna