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.

 

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)
«May 2024»
MonTueWedThuFriSatSun
2930
eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

Read more
1
eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

Read more
2
eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

Read more
345
6789101112
13
13/05/2024

Assessing Investigator Site File Systems for Clinical Research

A brief overview of who should use the eCF's newest assessment tool ... and why. This article can be viewed or downloaded by clicking "read more".

Read more
141516171819
20
Japanese translation of eSRA V2024

Japanese translation of eSRA V2024

Version 2024JP1 (20-May-2024)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

Read more
212223242526
272829303112
3456789

Upcoming events Events RSSiCalendar export