Adverse events and/or laboratory abnormalities identified as critical to safety evaluations should be reported to the sponsor according to what?

• A. Immediately to sponsor, without protocol-specific times.
• B. Only at the end.
• C. Only if the sponsor asks.
• D. In accordance with the protocol's specified time periods and sponsor requirements.

Answer: (D)

Safety reporting is governed by predefined timelines in the study protocol and the sponsor’s safety procedures. When adverse events or lab abnormalities are identified as critical to safety, they must be reported to the sponsor within the timeframes the protocol specifies and in line with the sponsor’s requirements. This ensures timely safety assessment and appropriate regulatory communication. Reporting immediately without protocol timing would bypass those designated windows, reporting only at the end would delay safety review, and reporting only if the sponsor asks would ignore the investigator’s obligation to follow the protocol. The correct approach is to follow the protocol’s specified time periods and sponsor requirements.