Drug Evaluation Committee Creating Efficient CSV Documents Using Vendor Documents
Electronic Standard for Medical Information Expert Committee
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 the system.
Electronic Standard for Medical Information Expert CommitteeIn order to resolve the above issues, Task Force 4 has prepared materials that can be used as reference materials to explain to vendors and how to efficiently create CSV documents.
We hope that this document will serve as a reference for the efficient creation of CSV documentation at each company.
- *The 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 Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee 2023 Task Force 4