Certified Clinical Research Associate (CCRA) Practice Exam

Which of the following statements is accurate regarding investigators and study conduct?

1. Investigators can delegate all responsibilities without supervision

2. Investigators are ultimately responsible for trial conduct

3. Investigator responsibilities are limited to data collection

4. Investigators have no role in participant safety

The correct answer is: Investigators are ultimately responsible for trial conduct

The statement that investigators are ultimately responsible for trial conduct is accurate and reflects the foundational principle of research ethics and good clinical practice. Investigators play a critical role not only in the planning of a study but also in its execution and oversight. This includes ensuring the integrity of the research, adhering to protocols, managing study staff, and, importantly, safeguarding participant welfare throughout the trial. The accountability of investigators is essential to maintaining ethical standards and ensuring that studies are conducted with the utmost diligence. Their oversight extends to every aspect of study conduct, making them essential in addressing any issues that arise during the trial. The incorrect options highlight misunderstandings about the responsibilities of investigators. For instance, while investigators can delegate certain tasks, they cannot delegate their overall responsibility, which includes ensuring that everyone involved in the study adheres to established protocols and regulatory requirements. Investigator responsibilities extend far beyond mere data collection and include critical aspects like participant safety, informed consent, and the ethical conduct of research.