What must be reported to the sponsor regarding adverse events?

• A. Only events required for regulatory filing, regardless of protocol.
• B. Only mild events that do not affect safety.
• C. Adverse events and abnormal test results required for safety evaluations should be reported according to the protocol.
• D. All events must be reported in real-time to the patients only.

Answer: (C)

The key idea is that safety reporting to the sponsor is defined by the study protocol. Investigators must report adverse events and abnormal test results that the protocol specifies as safety-related. This reporting supports ongoing safety evaluation, risk assessment, and regulatory submissions. Serious adverse events typically require prompt reporting, with follow-up information as it becomes available, and abnormal laboratory or diagnostic results that impact safety are included if the protocol requires them. It isn’t necessary to report every event, nor is it appropriate to report only to patients; the sponsor needs the safety data according to the protocol, so safety monitoring can be managed appropriately.