CDISC-Annotated CRF Repository in Japanese

A Summary of the Project

The Japan Agency for Medical Research and Development (AMED) was established in 2015 for the advancement of medical discoveries that make life better for everyone. Working under the Prime Minister’s Cabinet and national ministries, AMED provides a single avenue for researchers and institutions seeking funding for medical research and development.

The AMED funded a project, "Gap analysis for promotion of CDISC standards implementation in academia (2019/7/1-2022/3/31)" as a part of "Research on regulatory harmonization and evaluation of pharmaceuticals, medical devices, regenerative and cellular therapy products, gene therapy products, and cosmetics."

Aims of the project are to:

1. Survey the status and analyze gaps in CDISC implementation among academia.

2. Survey the status and analyze gaps in cooperation between academia and private companies on CDISC standards.

3. Develop an annotated CRF public repository to fill in the known gaps in academia.

"" has been developed for Aim #3 of the project. Only aCRFs from actual clinical research/trials are accepted for the repository. Currently aCRFs and define.xml from two GCP trials are submitted and posted on the website (July 2020). We are expecting academia to utilize the real aCRFs for their implementation of CDISC standards.

aCRF Public Repository Development Process

We have developed:

  • The specification of the website for the repository
  • The instructions for aCRF submitters
  • The workflow for submission, review and posting to the website
  • Beta version of the repository, which has been up and running at since July 2019.

Who Did the Work?

AMED project members (Aim #3):

  • Principal Investigator: Toshiki I. Saito , National Hospital Organization Nagoya Medical Center
  • Co-investigator: Takahiro Kiuchi, The University of Tokyo
  • Co-investigator: Matsuo Yamamoto, National Hospital Organization Nagoya Medical Center