Drug Evaluation Committee Toward Utilization of Structured Data in Notification of Clinical Trials
Electronic Standard for Medical Information Expert Committee
TF3-2 of the EI subcommittee organized and examined the possibility of utilizing the data contained in clinical trial notifications in multiple administrative procedures such as jRCT registration, application for approval, and post-approval procedures from a practical perspective.
Against the background of international trends represented by ICH M11 and the increase in international joint clinical trials, there is a need to improve the efficiency and quality of operations starting from clinical trial notification data. The purpose of this study is to achieve both efficiency and quality assurance in operations starting from clinical trial notification data.
In addition to presenting specific information that can actually be reused under the current system and the issues that arise in doing so, we also discussed the possibility of using data design and generation AI with an eye to the future.
By sharing the organization and suggestions obtained through this study, we hope to deepen common understanding, including industry and government, and link this to future practical discussions and examinations.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee Task Force 3-2
Toward Utilization of Structured Data in Notification of Clinical Trials