Drug Evaluation Committee Transparency checklist for de-identified/anonymized data sharing -From a checklist prepared by TransCelerate
November 2024
This report is based on “CLINICAL DATA SHARING: A PROPOSED METHODOLOGY TO ENABLE DATA PRIVACY WHILE IMPROVING SECONDARY USE,” published in August 2023 by TransCelerate BioPharma Inc.(hereinafter “TransCelerate”) in August 2023, titled “CLINICAL DATA SHARING: A PROPOSED METHODOLOGY TO ENABLE DATA PRIVACY WHILE IMPROVING SECONDARY USE,” and the “Transparency Checklist” in its Appendix.When sharing clinical trial data with data users (researchers), it is recommended to provide information on what de-identification or anonymization measures were applied to the shared data (variables).Using TransCelerate’s Transparency Checklist not only facilitates verification of the de-identification and anonymization applied to the shared data but also serves as documentation of the specific de-identification and anonymization methods applied by filling out the checklist’s columns. Providing this documentation to data users contributes to their proper understanding and use of the shared data.The Data Science Subcommittee’s FY2023 Continuing Task Force 2 provided an explanation in Japanese—including details on de-identification and anonymization methods—regarding how to complete the transparency checklist to promote understanding of clinical trial data sharing. We hope this report will contribute to promoting understanding of data utilization in Japan.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Data Science Subcommittee FY2023 Continuing Task Force 2