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What is the purpose of the Study Advisory Committee (SAC)?

The intent of the SAC described in the PFA is to ensure that a broad spectrum of stakeholders and
patients advise and assist the research team with further refinement of the study questions, outcomes,
and protocols. These stakeholders and patients must include national or regional organizations that
represent, at minimum, patients and/or families with lived experience, relevant clinicians, payers, and
health plans. Other representation may be recommended in collaboration with PCORI, including
individual patients with lived experience and other relevant stakeholders, including scientific and
methodological experts. However, PCORI understands that engagement structures and approaches vary
widely.

Other engagement approaches, such as forming stakeholder groups, panels, task forces, working
groups, and other bodies and/or involving individual patient and stakeholder partners in various ways,
are also permissible to employ, either in addition to or instead of the formation of the SAC. The SAC
provision is not meant to require that a separate governance and/or advisory entity be established
beyond the study governance and advisory structure the awardee has planned if an applicant already
has an approach for including the relevant, required stakeholders and patient partners. For clarification
in your application materials and for purposes of merit review, please indicate which body or structure is
filling the requirements of the SAC, including the requirements for in-person meetings at least two times
per year, and appropriate budgeting.

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