Drug Evaluation Committee Explanation of the CDASH standard that defines data items for case report forms
Clinical Evaluation Subcommittee Data Science Subcommittee Electronic Standard for Medical Information Expert Committee
December 2011
The Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee, Japan CRO Association, and the Japan CDISC Coordinating Committee / CDISC Japan User Group have expressed the following opinion: "The introduction of CDISC, a common global data standard, into the Japanese clinical trial environment will enable more efficient and rapid operations and the acquisition of higher quality data. This will be the basis for creating an environment in which world-class clinical trials can be conducted. And this idea can be shared with all other parties involved in clinical trials. Explanation of CDASH, which defines data items for CRFs, was provided among the CDISC standard groups so that all those involved in clinical trial-related work can visualize and understand the CDISC standards. This will also make it possible to foster discussion in Japan about operational methods and suggestions for improvement. This document consists of a general explanation of data standards and Explanation of individual data items defined by CDASH. The former is an Explanation for all interested parties, while the latter is for those who actually use CDASH, and should be referred to when designing a CRF or preparing a guide for filling out a CRF. We hope that all parties involved will read this document. We hope that this document will encourage active discussions among all parties involved.
Explanation of the CDASH standard that defines data items for case report forms (595KB)