An ad hoc committee of the Institute of Medicine will conduct a study to develop guiding principles and a framework for the responsible sharing of clinical trial data. For purposes of the study, the scope will be limited to data gathered under randomized controlled clinical trials, and data sharing will include both unilateral disclosure of data, e.g., by a research sponsor or regulator (data transparency), and exchange of data among more than one organization or sector, whether or not those data are ultimately made public. Specifically, the committee will: