How many co-PIs are acceptable? Could there be three, including two co-PIs who are running the clinical trial plus one co-PI who represents the Data Coordinating Center (DCC)?

It is PCORI policy across all research award mechanisms that no more than two PIs (dual-PIs) can be named on an application. When proposing an application with dual-PIs, you must designate one individual as the Contact PI. The Contact PI is responsible for submitting the application and will serve as PCORI’s primary point of contact for all communication. PCORI asks that you rely on the Leadership Plan Template (embedded within the Research Plan Template) to describe the significance of each individual’s role on the leadership team (Dual PIs, and Co-Is) to capture the scope of their responsibilities in decision-making, management, and advisory consultation.  

For the PLACER PFA, PCORI requires that the Principal Investigator (PI) of the DCC and the PI of the Clinical Coordinating Center (CCC) be named and serve as dual-PIs to promote parity, scientific independence, and autonomy of clinical, data management, and analytical input into study decisions. If other arrangements are proposed, applicants must seek prior approval from PCORI to ensure the co-equal and independent voices of the CCC and DCC in trial design, conduct, and oversight. Please use relevant sections of the research plan template to demonstrate DCC parity, scientific independence, and autonomy in study decisions.