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

The investigator plays a crucial role in the clinical trial process, including the assessment of adverse events. Determining the severity of an adverse event is primarily within the scope of the investigator’s responsibilities because they are trained and qualified to evaluate the clinical significance of the event based on their medical knowledge and experience.

The investigator has firsthand knowledge of the study participants, their medical histories, and the study protocol. This context allows them to assess the seriousness of the adverse event accurately. They make clinical judgments about the event's impact on the patient's health and safety, which is essential for ensuring that appropriate measures are taken to protect participants and comply with regulatory requirements.

While site staff and the sponsor may have roles in adverse event reporting and management, it is the investigator who ultimately assesses the severity. Therefore, the investigator's assessment is vital for reporting to regulatory authorities and ensuring the safety and ethical conduct of the study.