Estimated Time per Activity* Day 0 CMU IRB RELIANCE IRB Submission & Review Process PPI submits IRB Application [or IRB Amendment] and RI(s) IRB documentation to the Reviewing IRB PPI/RI(s) secure all Departmental, School and Institutional approvals (e.g., other regulatory committee approvals) required at their institution. Reviewing IRB HRP staff conduct initial pre-review/ assessment; works with the PPI to have protocol “IRB Ready” PPI working with Reviewing IRB obtains approvals from the Reviewing institution. RI(s) at Relying site secures approvals from Relying institution. 3–14 days 1-3 days Reviewing IRB sends the “IRB ready” protocol to Relying IRB(s) to identify any substantive and/or local issues 3-14 days Relying IRB(s) sends comments to Reviewing IRB 5-23 days Reviewing IRB reviews protocol, if approved provides approved documents to Relying IRB(s) For New IRB Applications Only PPI at Reviewing Site may initiate research if all institutional requirements are met (e.g., contract finalized) Relying IRB reviews IRB-approved documents and confirms that other applicable institutional requirements are met. Submits IRB Reliance Letter to the Reviewing IRB. Releases institutionspecific IRB-approved documents to RI(s). RI(s) at Relying Site may initiate research if all institutional requirements are met (e.g., sub-contract finalized) 3-14 days *NOTE: Timeline estimates do not include PPI/ RI(s) response time, IRB determinations requiring revisions and/or resubmission, and review timelines for other regulatory committees. The Project Principal Investigator or ‘PPI’ is the primary individual responsible for submission of required applications and reports to the Reviewing IRB. The Relying Investigator or ‘RI’ is the Principal Investigator or Lead Researcher (LR) at the Relying institution.