Certified Clinical Research Associate (CCRA) Practice Exam

What is the Investigator's role during a trial team meeting regarding SAE reports?

1. To encourage extended reporting timelines

2. To instruct on timely reporting to the Sponsor

3. To discuss trial budget concerns

4. To monitor participant eligibility

The correct answer is: To instruct on timely reporting to the Sponsor

The Investigator's role during a trial team meeting regarding Serious Adverse Event (SAE) reports is to instruct on timely reporting to the Sponsor. This responsibility is crucial because timely reporting ensures that the Sponsor can adequately assess the safety and integrity of the trial. The Investigator plays a vital role in maintaining communication with the Sponsor and ensuring that all safety concerns are reported promptly, which is essential for patient safety and regulatory compliance. This interaction helps in the evaluation of the risks associated with the investigational product and aids in necessary adjustments to study protocols or participant management. While the other options may reflect responsibilities related to clinical trials, they do not align with the specific duties of the Investigator concerning SAE reports. Encouraging extended reporting timelines could compromise the response to potential safety issues. Discussing trial budget concerns or monitoring participant eligibility, although important aspects of trial management, are not directly relevant to the specific task of SAE reporting. Therefore, the focus on instructing timely reporting aligns with the critical nature of ensuring participant safety and adhering to regulatory requirements.