Drug Evaluation Committee Creating Efficient CSV Documents Using Vendor Documents
Electronic Information Subcommittee
April 2024
CSV is essential when using computerized systems in clinical trials, because while the creation of CSV documentation is the responsibility of the pharmaceutical company as the system owner, the vendor's responsibility in SaaS and other CSV is increasing, and the materials created by the vendor in documentation are becoming more important, There is a need for more efficient documentation using materials provided by vendors who have built systems.
In order to resolve the above issues, Task Force 4 of the Digitization Information Subcommittee has prepared explanatory materials for vendors and reference materials on how to efficiently create CSV documents.
We hope that this document will serve as a reference for efficient creation of CSV documents at each company.
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As of December 2023The explanatory materials are provided in pptx format so that they can be modified by users, but they are also available in pdf format in consideration of the possibility of garbled characters depending on the viewing environment.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Electronic Information Subcommittee, Task Force 4, 2023
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