Certified Clinical Research Associate (CCRA) Practice Exam

Investigators must report any deviations from the protocol to the sponsor and the Institutional Review Board (IRB) as soon as possible. This is essential because such deviations could have implications for participant safety, study integrity, or regulatory compliance. Timely reporting allows the IRB and sponsor to assess the significance of the deviation, decide if any corrective actions are necessary, and ensure the study continues to meet ethical standards and regulatory requirements. Early notification is important for maintaining transparency in the research process and upholding the rights and welfare of participants. By promptly reporting deviations, investigators allow for an evaluation of the potential impact on the study's outcomes and participant safety, which is a critical responsibility as part of ethical research conduct. Other options may not provide the necessary action. Informing participants of the deviation, for instance, might be warranted in some cases, but it does not fulfill the obligation to report to oversight bodies. Waiting until the next scheduled meeting could delay critical action that may be needed immediately, while merely documenting the deviation without further action does not ensure that appropriate oversight addresses safety and compliance issues.