Drug Evaluation Committee Mapping List of Clinical Trial Documents in Japan to Trial Master File Reference Model Ver3.0 Revised March 2020
Electronic Information Subcommittee
March 2020
In March 2016, Task Force 3 of the EI Subcommittee (TF3) released a mapping list of clinical trial-related documents in Japan to the TMF Reference Model (Ver. 3.0). With the release of this mapping list, we proposed that clinical trial-related documents in Japan can be managed by classification corresponding to the TMF Reference Model, and that document management can be made more efficient by promoting the use of overseas eTMF systems, for example.
Meanwhile, four years have passed since the release of the eTMF Reference Model, and the number of companies that have introduced and started operating electromagnetic storage of clinical trial-related documents and TMF management using the eTMF system in Japan has increased since the previous mapping study, and operational results have been accumulated. Therefore, the EI Subcommittee TF3 has conducted a review (revision) of the current mapping list by investigating and verifying problems in the current actual operation.
The result of the review was a "Mapping List of Japanese Clinical Trial Documents to the TMF Reference Model," which was revised based on a survey of the actual operation of the mapping list in the companies to which the EI Subcommittee TF3 members belong and discussions with related organizations, as well as a "Cover List" that summarizes the targets and policies when mapping. The "Cover Letter" summarizing the mapping targets and policies was compiled as a deliverable.
The version of the TMF Reference Model to be mapped remains the same as Ver. 3.0 at the time of the previous mapping (Ver. 3.1.0 was released in September 2018; however, since there were no major changes in artifacts and other content, we decided to keep the version as Ver. 3.0).
TMF We hope that by recommending and promoting the common use of the Reference Model, we can help improve the efficiency of TMF management in the industry as a whole.
Mapping List of eTMFRM and Japanese Clinical Trial Documents Revised March 2020 (502KB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables