Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

In clinical trials, while specific tasks may be delegated to various personnel, the ultimate responsibility for ensuring compliance with regulatory standards, trial protocols, and ethical guidelines remains with the investigator. The investigator is the individual who has the overall oversight of the study and is accountable for the integrity of the trial and the welfare of the participants.

The investigator must ensure that all team members are adequately trained and competent to perform their assigned tasks. They are also responsible for maintaining the accurate documentation required by regulatory authorities and for ensuring that the trial adheres strictly to both the approved study protocol and applicable laws and regulations. This encompasses not only compliance with Good Clinical Practice (GCP) guidelines but also adherence to policies specific to the institution or the ethics boards involved.

The other roles, such as the clinical trial coordinator, research scientist, and regulatory affairs officer, while important in their contributions to the trial’s conduct, do not hold the same level of overarching responsibility for compliance. They play supportive or specialized functions, but the investigator bears the full legal and ethical responsibility for the trial’s successful conduct and compliance.