Drug Evaluation Committee Explanatory material on the basics of utilizing eTMF (electronic Trial Master File) and TMF Metrics
Electronic Information Subcommittee
March 2022
The Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee Electronic Information Subcommittee Task Force 3 aims to promote the use of electronic systems, eTMF systems and TMF Metrics in Japanese pharmaceutical companies. The document is a tool to support the introduction and promotion of eTMF (electronic Trial Master File) and TMF Metrics.
The TMF Metrics Explanatory Material is separate from the main document and is intended to be used for internal training and other purposes. The explanatory material on TMF Metrics is separate from the main body of the report and covers a wide range of topics, from explanations of TMF Metrics to preparation for evaluation using TMF Metrics and 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, Committee on Drug Evaluation
eTMF Information Subcommittee, Task Force 3, FY2021
Toward the Utilization of eTMF and TMF Metrics (584KB)
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