The PCORI Research plan is a key component of an application submission; is directly tied to the executed contract; and contains an overview of the study aims, PICOTs (where applicable; most Methods projects do not include PICOTs), and approach for conducting the study. Once the contract is executed, any changes made to the PCORI Research Plan must be approved by PCORI prior to implementation.
The study protocol is a document that describes how a clinical research study will be conducted (the objective(s), design, methodology, statistical considerations, and organization of the study) and ensures the safety of the study participants and integrity of the data collected. The study protocol is approved by the study institution and associated IRB, as necessary. Any protocol changes that impact the PCORI Research Plan must be discussed and approved by PCORI. The study protocol might also be included as a key deliverable of a PCORI study milestone.