When will PCORI include the data sharing milestones and budget into the awardee contract?

For required awardees Cycle 1 2019 – Cycle 3 2021, PCORI will contact awardees directly to include data sharing milestones into the contract via a contract modification and address the related data sharing budget materials post contract execution. Starting with Cycle 1 2022 required awardees, data sharing milestone will be included in the contract prior to contract execution while the data sharing budget will be addressed closer to the DFRR due date.

Note: For awards made under a 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 contract modification. Data sharing milestones should NOT be included in the PLACER feasibility milestone schedule at the time of initial contract execution.