Beginning with Cycle 3 2018, the PCORI Contract for Funded Research will include express obligations to comply with the terms of this Policy. Applicants funded through the Pragmatic Clinical Studies and Targeted Funding Announcement mechanisms will be required to deposit the Full Data Package (or required data elements, as applicable) in a PCORI-designated repository. Applicants funded through the Broad Funding Announcement (Assessment of Options, Improving Healthcare Systems, Addressing Disparities, Communication and Dissemination Research, Improving Methods) will be required to maintain the Full Data Package for seven (7) years.
A full data management and data sharing plan for the proposed research project will not be evaluated at the application stage; however, such a plan will be required and must be submitted to PCORI as part of the Full Protocol if an award is made. As described in the Policy, the plan must adhere to the PCORI Methodology Standards for Data Integrity and Rigorous Analyses, specifically Standard IR-7.