Under which conditions must the sponsor submit an IND safety report to the FDA?

The correct answer is that the sponsor must submit an IND safety report to the FDA when the event is serious, unexpected, and drug-related. This requirement is grounded in the regulatory framework governing clinical trials, which emphasizes participant safety and the need for timely reporting of adverse events.

A serious adverse event (SAE) is one that results in significant outcomes such as death, life-threatening situations, hospitalization, disability, or congenital anomaly. An event is considered unexpected if its nature or severity does not align with the information previously provided in the investigational new drug (IND) application or product labeling. Additionally, for an event to be classified as drug-related, there must be a reasonable possibility that the drug contributed to the occurrence of the adverse event.

When these criteria are met, it is crucial for sponsors to report these findings to the FDA promptly, facilitating their assessment of the safety profile of the drug and enabling necessary actions to protect participants in ongoing and future studies. Reporting such events ensures regulatory oversight and encourages transparency, helping maintain public trust in clinical research.

In contrast, the other answer choices do not fully capture the regulatory requirements for submitting IND safety reports. Reporting only severe events disregards the importance of unexpected and drug-related criteria. Subject requests and investigator identifications do