Certification for IRB Professionals (CIP) Practice Exam

What should an investigator do after discovering a serious, unanticipated adverse drug experience in a clinical trial?

1. Send a letter to the study sponsor

2. Report the adverse drug experience in a timely manner

3. Wait for further investigation before reporting

4. Inform the participants immediately in person

The correct answer is: Report the adverse drug experience in a timely manner

When an investigator discovers a serious, unanticipated adverse drug experience during a clinical trial, it is critical to report the adverse event in a timely manner. Prompt reporting is essential for several reasons: 1. **Patient Safety**: Quick communication about adverse events helps to ensure the safety of participants and allows for timely interventions if necessary. 2. **Regulatory Compliance**: Regulatory authorities require that investigators report serious adverse events within specified timeframes to ensure ongoing oversight of the study and its safety. 3. **Data Integrity**: Early reporting contributes to maintaining the integrity of the study data, allowing the sponsor and regulatory bodies to assess risks and benefits continuously throughout the trial. 4. **Informed Decision-Making**: Timely reports allow sponsors and study monitors to make informed decisions about the continuation of the trial, potential modifications to the protocol, or implementing additional protective measures for participants. In contrast, other options either delay necessary action or are insufficient in addressing the situation adequately. Sending a letter to the study sponsor might not fulfill the urgency required in reporting such serious experiences. Waiting for further investigation before reporting creates unnecessary risks and potentially compromises patient safety. Informing the participants immediately in person, while it may be important to communicate findings, does not replace the formal requirement