Title: Protocol Deviations Handling and Reporting Procedure Introduction and Purpose: Protocol deviations in clinical research, whether from the clinical research protocol, Good Clinical Practice (GCP) guidelines, or applicable federal regulations, have the potential to jeopardize the safety and rights of study participants and compromise the scientific integrity of the study. Therefore, it is crucial to identify, address, and correct deviations when possible, as well as to establish preventive measures to mitigate future occurrences. Deviations must be documented in accordance with GCP guidelines and reported to the Institutional Review Board (IRB) following the procedures outlined in this Standard Operating Procedure (SOP) and in compliance with IRB policies and procedures. The deviation reporting guidelines provided in this SOP pertain to studies overseen by the clinical site IRB. For studies under a Central IRB (CIRB) or another IRB of record, both the CIRB or IRB-specific dev...