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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.
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(04/11/2025 - 06/11/2025)
(04/11/2025 13:00 - 06/11/2025 15:00)
Registration for the eCF Asia Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.
The workshop will be available for in-person participation only. There will be a networking/social event in the evening. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here
Registration for the eCF Europe Autumn Hybrid Workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Medidata in London, UK, on November 4-6, 2025
The workshop will be available for both in-person participation and remote access. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 in-person seats depending on your membership type and as allocated by your eCF Primary Representative. Remote access of the live-streamed workshop is available gratis to all staff from eCF Member companies. Click to get more information on the planned topics.
Technology Showcase: eClinical Solutions: elluminate Assist – AI-driven SDTM study data analysis assistant
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors. Any member can participate that has an interest in the topic area. Any eClinical Forum Member may suggest or present a Technology Showcase. READ MORE for details on this Technology Showcase.