How should an investigator respond after discovering a serious adverse event during a clinical trial?

How should an investigator respond after discovering a serious adverse event during a clinical trial?

• A. Do not report it to the IRB.
• B. Report the event if there are multiple occurrences.
• C. Report it timely in accordance with IRB procedures.
• D. Include it in the annual review report only.

Answer: (C)

The proper response for an investigator who has discovered a serious adverse event during a clinical trial is to report it timely in accordance with the Institutional Review Board (IRB) procedures. This is crucial because serious adverse events can have significant implications for patient safety, ongoing trial validity, and regulatory compliance. Timely reporting ensures that the IRB can assess the risk to participants and determine if there needs to be an adjustment in the study protocol, additional monitoring, or other actions to protect the participants’ welfare. It is a part of ethical research conduct to keep the oversight body informed about any events that could impact the health and safety of the participants or the integrity of the trial. This approach aligns with regulatory requirements and ethical guidelines that govern clinical trials, emphasizing the importance of transparency and expedited communication with oversight bodies.

The proper response for an investigator who has discovered a serious adverse event during a clinical trial is to report it timely in accordance with the Institutional Review Board (IRB) procedures. This is crucial because serious adverse events can have significant implications for patient safety, ongoing trial validity, and regulatory compliance.

Timely reporting ensures that the IRB can assess the risk to participants and determine if there needs to be an adjustment in the study protocol, additional monitoring, or other actions to protect the participants’ welfare. It is a part of ethical research conduct to keep the oversight body informed about any events that could impact the health and safety of the participants or the integrity of the trial.

This approach aligns with regulatory requirements and ethical guidelines that govern clinical trials, emphasizing the importance of transparency and expedited communication with oversight bodies.