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Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

We included regulatory documents (n=4) from the scientific literature search as well as from the gray literature search (n=13). Our results indicate that clinical trial regulatory frameworks aim to make data available for noncommercial use for researchers. We noted that clinical trial agencies lack comprehensive approaches that facilitate data sharing.

Nachiket Gudi, Prashanthi Kamath, Trishnika Chakraborty, Anil G Jacob, Shradha S Parsekar, Suptendra Nath Sarbadhikari, Oommen John

J Med Internet Res 2022;24(5):e33591