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

When an investigator discovers a serious, unanticipated adverse drug experience in a clinical research trial, the appropriate course of action is to report it in a timely manner according to the policies set forth by the Institutional Review Board (IRB). This is critical for several reasons.

Firstly, the IRB is responsible for ensuring the safety and welfare of participants involved in research. Reporting adverse experiences quickly allows the IRB to assess the information and determine if any changes to the study protocol, informed consent documents, or participant monitoring plan are necessary. It ensures ongoing oversight of the study and immediate steps can be taken to protect participants.

Secondly, regulatory bodies like the FDA require prompt reporting of serious adverse events. This ensures that there is a record of issues that may affect not only the current study participants but also informs wider clinical practice and future research endeavors.

In contrast, other options suggest delayed or insufficient reporting, which does not align with best practices for patient safety and ethical research conduct. Reporting as part of a continuing review does not address the urgent need for immediate action following a serious adverse event. Furthermore, disregarding the report because the adverse experience is deemed common diminishes the importance of tracking severity and unexpected outcomes and could lead to harmful consequences for participants. Lastly, reporting