The Informed Consent Subgroup has submitted comments on EMA Draft Policy 0070. This subgroup is part of the second phase of MRCT's efforts related to Clinical Trial Data Sharing and Transparency, called "Implementation and Solutions". Members of academia, industry, and non-profits contributed to this effort. Please find the group's final comments attached here.
Proceedings are posted under "Resources" for the Clinical Trial Data Sharing and Transparency Conference, co-hosted by the MRCT Center and the Petrie Flom Center of Harvard Law School. For those in attendance, they will serve as a good reminder of the potential data sharing models developed by four MRCT working groups.