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Although Letters of Support are not required at the LOI stage, do applicants need to confirm all study sites, especially if one is choosing between a few but needs to have more time regarding visibility and buy-in?

While PCORI is receptive to applicants engaging in a longer process to set up clinical partners, it is not necessary that they are all confirmed in the LOI. However, you should speak to the likely clinical partners and document this within your LOI, including details on characteristics within that site. There is potential that the clinical sites could affect your sample size, and we would want to know that (as well as any changes) between the LOI and application stage.

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