Drug Evaluation Committee Points to keep in mind regarding the electromagnetic storage of clinical trial-related documents
Electronic Information Subcommittee
March 2016
In recent years, pharmaceutical companies have begun to consider introducing dedicated systems for electronic storage of clinical trial-related documents in electromagnetic records (eTMF). However, there is a lack of studies from the perspective of pharmaceutical companies on what kind of system is best suited for each company and what issues need to be addressed in order to introduce such a system.
In addition, the eTMF uses a list of clinical trial-related documents called the DIA Reference Model, but the process of assigning (mapping) clinical trial-related documents to this list in Japan is currently conducted by each company, and there is no uniformity among companies. As a result, when storing or transferring clinical trial-related documents to medical institutions, contract research organizations (CROs), or at the time of co-development, it takes a lot of effort to re-map the documents, which is not originally necessary. With the cooperation of the members of the DIA subcommittee, who have experience in classifying Japanese clinical trial documents to the DIA Reference Model, we have compiled a cover letter summarizing the current mapping of Japanese clinical trial documents to the DIA Reference Model and the policy for mapping as a deliverable. This document was developed with the cooperation of the members of the DIA Reference Model Committee.
We hope that this document will be helpful to companies when establishing/operating eTMFs.
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