Public Release: English Translation of V2.00 of Japan EDC Management Sheet

Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued the first version of EDC Management Sheet in 2013 to ensure the computerized system used in clinical trials comply with the electronic records and electronic signatures guideline as well as the GCP regulations. This sheet is reviewed at the time of PMDA reviews and inspections.

You can download the original in Japanese from: https://www.pmda.go.jp/review-services/inspections/reexam-reeval/0005.html

Japan Pharmaceutical Manufacturers Association (JPMA), an organization representing the research-based pharmaceutical industry operating in Japan, volunteered to translate the EDC Management Sheet  V1.0 into English, and posted it on their website.  In July 2021, PMDA made minor changes and issued v2.00 of the EDC Management Sheet.  JPMA made clear they would not translate it this time.  The eClinical Forum thought it a good idea to translate it to contribute to the industry.  JPMA generously agreed for the eClinical Forum to build upon their v1.00 translation as a basis.  Also, JPMA requested to make it clear that JPMA was not involved in the v2.00 translation.