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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 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, Co-PIs, and Co-Is) to capture the scope of their responsibilities in decision-making, management, and advisory consultation. 

While we recommend the PI of the DCC to be a dual-PI on the LOI/Application, it is not a requirement. It is, however, strongly encouraged. Should an applicant choose to name the leader of the DCC as a Co-Investigator rather than a Dual-PI, it will be incumbent upon the applicant team to provide strong evidence that this arrangement will ensure the independent and co-equal voice of the DCC in research design and oversight functions. Please use relevant sections of the research plan template to demonstrate DCC parity, scientific independence, and autonomy in study decisions.

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