What Is PCORI’s Policy for Data Management and Data Sharing and How Does It Apply to This PFA?

Fundamentally, the Policy articulates PCORI’s expectation that Awardees make the data from their PCORI-funded research projects available to third-party requestors. Importantly, it provides funding to our Awardees for their time and effort in preparing the data to be shared. The Policy includes details about what data certain Awardees will be expected to deposit into a designated data repository and when that data would be available for third-party requests. It describes the data request process, the criteria used to assess the scientific merit of the requests, and the independent committee that will review data requests. Please refer to the Policy webpage, data sharing FAQs, and the PFA for more information on PCORI’s Policy for Data Management and Data Sharing.

For awards made under the PLACER funding mechanism, awardees will only be required to deposit the Full Data Package if the study proceeds to the full-scale study phase. Studies transitioning successfully to the full-scale study phase will have the data sharing milestones added to the full-scale study phase milestone schedule as part of the negotiation of the contract modification. The Full-Scale Study Phase Data Safety and Monitoring Plan should ensure compatibility with PCORI’s Policy for Data Management and Data Sharing with respect to institutional policies and informed consent language.