A compliance officer for a start-up biologic company that is planning to launch its first clinical trial. Before the trial begins, the company wants to develop a comprehensive policy explaining what data from the trial will be made available to other researchers or the general public, either routinely or on request. The compliance officer is asked to draft a memo that explains the issues the company should consider and presents your recommendations as to the most desirable approach.The memo should include a discussion of how other companies have addressed these issues, as well as any applicable legal requirements in the U.S. and the E.U.