Drug Evaluation Committee Explanation of the CDASH standard that defines data items for case report forms
Clinical Evaluation Subcommittee Data Science Subcommittee Electronic Information Subcommittee
December 2011
The Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association, the Japan CRO Association, and the Japan CDISC Coordinating Committee / CDISC Japan User Group have agreed that "the penetration of CDISC, the universal data standard, into the Japanese clinical trial environment will enable more efficient and rapid operations and the acquisition of high-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. In order to help all those involved in clinical trial-related work to visualize and understand the CDISC standards, we provided an explanation of CDASH, which defines data items for CRFs, among the CDISC standard groups. 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 an explanation of individual data items defined by CDASH. The former is intended 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 CRF entry guide, and should be read by investigational sites even before actually seeing a CDASH-compliant CRF. We hope that all parties involved will read this document. We hope that this document will stimulate active discussions among all parties involved.
Explanation of the CDASH standard that defines data items for case report forms (595KB)
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