How was the Policy for Data Management and Data Sharing developed?

The sharing of clinical research data is a complex issue, and we arrived at this policy through careful deliberation, listening to stakeholders and a commitment to learning by doing. This included obtaining public comment on the Policy; consulting an Expert Advisory Group convened by PCORI for their experience with data sharing issues; conducting a Pilot Project that brought together data repository organizations with PCORI Awardees to assess technical and operational challenges related to implementing this Policy; and speaking with other funders and regulatory agencies about their experiences in developing data sharing guidance and policies.