Drug Evaluation Committee Quality Control-Fraud Detection Prevention
Data Science Subcommittee
December 2023
On July 5, 2019, ICH E6 (R2) became Step 5 in Japan, clearly stating that the implementation of a Quality Management System (QMS) into clinical trials and research is the responsibility of the sponsor. During this period, the Data Science Subcommittee of the Committee on Drug Evaluation of the Japan Pharmaceutical Manufacturers Association (hereafter referred to as the Data Science Subcommittee of the Pharmaceutical Manufacturers Association of Japan) released "Central Monitoring: Investigation of Risk Indicator and Fraud Detection" in December 2020. The results were compared with those of QMS and RBM. As a result, fewer companies have introduced FD than QMS and RBM. The TF decided to conduct another survey of member companies, a vendor survey, and a literature survey in 2019 and beyond. In addition, specific FD methods will be introduced to encourage the actual implementation of FD methods. We hope that this report will serve as a reference for promoting FD, RBM, and CSM in each company and, by extension, help improve the quality and ensure the transparency of clinical trials.
Japan Pharmaceutical Manufacturers Association
Committee on Drug Evaluation, Data Science Subcommittee
Continuing Task Force 5-1 for FY2023
Quality Control - Fraud Detection Prevention (1,134 KB)
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