Drug Evaluation Committee Explanation of Basic Items for Utilization of eTMF (electronic Trial Master File) and TMF Metrics
Electronic Standard for Medical Information Expert Committee
March 2022
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Electronic Standard for Medical Information Expert CommitteeTask Force 3 aims to promote the use of electronic TMF (electronic Trial Master File) and TMF Metrics in Japanese pharmaceutical companies. Explanation of the basics for the use of eTMF (electronic Trial Master File) and TMF Metrics" has been prepared as a tool to support the introduction and promotion of eTMF and TMF Metrics.
The TMF Metrics Explanation is separate from the main document and is intended to be used for internal training and other purposes. The TMF Metrics Explanation is separate from the main body of the document and covers a wide range of topics, from Explanation of the TMF Metrics to preparation for evaluation using the TMF Metrics to specific calculation methods.
We hope that this document will be of assistance to those who are working on the spread and effective use of electronic and eTMF systems.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee 2021 Task Force 3