Drug Evaluation Committee Central Monitoring Fact-finding Survey on Risk Indicator and Fraud Detection
Data Science Subcommittee
December 2020
ICH E6 (R2) became Step 5 in Japan on July 5, 2019, and the Ministry of Health, Labour and Welfare, Consumer Health Bureau, Drug Evaluation and Control Division has issued guidance on ICH E6 (R2), which has been incorporated into domestic regulations. The guidance clearly states that the sponsor is responsible for implementing the Quality Management System (QMS) into clinical trials and research. For this reason, we conducted a questionnaire survey of member companies of the Data Science Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and a literature review of published papers to investigate the implementation status of central monitoring methods for monitoring risks in clinical trials and Fraud Detection methods for monitoring research misconduct. Based on the results, we will introduce the current implementation status of the Risk Indicator, its thresholds (Thresholds), and Fraud Detection at each company as examples of detailed settings, as well as the status of publications in the literature.
In addition, in order to implement RBM, various systems that enable monitoring of clinical trial progress and risk control status have been developed by analytical software vendors in recent years. In addition, monitoring CROs are now offering contract services to support the implementation of RBM based on such systems. For this reason, with the cooperation of the Japan CRO Association and other organizations, we asked several CROs and vendors who introduced their systems to us to provide information, and we present the characteristics of the systems and services we interviewed from the companies that cooperated with us.
We hope that this document will help to refine the RBM practiced by each company and improve quality through the implementation of a clinical QMS.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation, Data Science Subcommittee
FY2019 Task Force 3 Central Monitoring
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