Drug Evaluation Committee Efficient Creation of CSV Documents Using Vendor Materials
April 2024
CSV is mandatory when using computerized systems in clinical trials. While the creation of CSV documents is the responsibility of the pharmaceutical company as the system owner, vendors—particularly those providing SaaS solutions—are assuming an increasing share of CSV responsibilities. As a result, the materials prepared by vendors are becoming increasingly important for documentation. Therefore, there is a growing need to create documents more efficiently by utilizing materials provided by the vendors who built the systems.
Electronic Standard for Medical Information Expert CommitteeTo address the above challenges, Task Force 4 has prepared explanatory materials for vendors and reference materials on efficient methods for creating CSV documentation.
We hope this material will serve as a useful reference for companies seeking to create CSV documentation efficiently.
- *The explanatory materials are provided in PPTX format so that users can modify them; however, we are also publishing them in PDF format to account for the possibility of garbled text depending on the viewing environment.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee FY2023 Task Force 4