The PLACER PFA recommends a dual-PI arrangement for this PFA where one PI is based at the data coordinating center; a strong justification is required for any alternative to this arrangement. Given the size, complexity, and anticipated risks of the research sought by PCORI under PLACER, any stakeholder proposed to serve as Dual-PI would need to be exceptionally well-qualified and experienced in clinical trial leadership. Stakeholders without such extensive qualifications can nonetheless make significant contributions in PLACER trials by serving as Co-Investigators or in other leadership roles within the governance or management structure of the study.
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