Certified Clinical Research Associate (CCRA) Practice Exam 2026 – All-in-One Guide to Master Your Certification!

When an investigator plans to deviate from the protocol, obtaining approval from both the sponsor and the Institutional Review Board (IRB) is essential. This requirement is rooted in the need to ensure that any changes made to a study protocol are ethical and within regulatory compliance.

The sponsor, who oversees the study, must have insight into changes that could affect the study's validity or the safety of the subjects involved. The IRB's primary role is to safeguard the rights and welfare of the study participants, thus they must evaluate whether the deviation will significantly increase any risks or alter the ethical considerations initially approved.

Additionally, obtaining this approval helps ensure that all changes are documented and reported as necessary, maintaining the integrity of the research and aligning with regulatory expectations. In contrast, verbal consent from subjects does not grant the necessary oversight for protocol deviations, nor does documentation from fellow investigators suffice for ethical or compliance purposes. Lastly, while approval from regulatory authorities might be necessary in specific situations, it does not replace the requirement for prior approval from both the sponsor and the IRB in most cases of protocol deviation.