WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

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

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.

JP2.00EN2.01 (July 4, 2022) - Minor changes in cells C36, C85 and D51 of [Operational Procedure] worksheet

Documents to download

Print
Tags:
Rate this article:
No rating

NOT A MEMBER?

Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
«August 2022»
MonTueWedThuFriSatSun
2526
HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022

HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022

We are pleased to announce our next Workshops:

- Europe: Uppsala, Sweden on 4-6 October 2022 kindly hosted by Viedoc Technologies

- Asia-Pacific: Tokyo, Japan on 25-26 October 2022 kindly hosted by Bristol-Myers Squibb

- Americas: North Wales, Pennsylvania on 14-16 November 2022 kindly hosted by Merck & Co.

The workshops will be available for face-to-face and remote participation. We will soon be in touch with registration details but in the meantime please save the dates in your calendar.

We are building exciting agendas for the meetings. If you can contribute or have topics to propose, then please get in touch.

Read more
2728293031
12
Views & News -- August 2022

Views & News -- August 2022

We send a monthly email newsletter to our members to keep them abreast of eCF Views (items on our online members-only discussion board) and eCF News (upcoming events, activities of our project teams, etc). If you would like to be included in the monthly e-newsletter mailing, please send a note to Webmaster3@eclinicalforum.org.   Click "Read More" to see this month's "Views & News"!

Read more
345
eClinical Forum APAC Workshop

eClinical Forum APAC Workshop

This meeting is kindly hosted by Bristol Myers Squibb and held in a facility near the Tokyo Station.  We are currently accepting suggestions for agenda topics and/or presenters in the areas of  Decentralized Clinical Trials, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.

Read more
67
8910
Birds-of-a-Feather Round Table Discussion:  Measuring Clinical Trial Data Quality

Birds-of-a-Feather Round Table Discussion: Measuring Clinical Trial Data Quality

We will be discussing the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management.

Read more
11121314
15161718192021
22232425262728
2930311234

Upcoming events Events RSSiCalendar export