Drug Evaluation Committee Transparency checklist for de-identified/anonymized data sharing -From a checklist prepared by TransCelerate
Data Science Subcommittee
November 2024
This report is based on the "CLINICAL DATA SHARING: A PROPOSED METHODOLOGY TO ENABLE DATA PRIVACY WHILE IMPROVING SECONDARY SECURITY" released by TransCelerate BioPharma Inc. in August 2023. IMPROVING SECONDARY USE" and the "Transparency Checklist" in its Appendix. When sharing clinical trial data with data users (researchers), it is recommended that information be provided on what de-identification/anonymization has been applied to the data (variables) being shared. TransCelerate's transparency checklist can be used not only to check what de-identification/anonymization has been applied to shared data, but also to provide information on what de-identification/anonymization methods have been applied by filling in the columns of the checklist, which can be provided to data users for appropriate understanding and use of shared data. The Data Science Subcommittee FY2023 Continuing Task Force 2 provided explanations in Japanese on how to include in the transparency checklist to promote understanding of clinical trial data sharing, including Explanation of de-identification/anonymization methods. We hope that this report will help promote understanding of the use of data in Japan.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee 2023 Ongoing Task Force 2