SAEs that do not require immediate reporting are identified by the protocol.

• A. The protocol may identify certain SAEs that do not require immediate reporting.
• B. All SAEs require immediate reporting.
• C. SAEs should never be reported.
• D. SAEs must be reported only at the end.

Answer: (A)

In protocol-based safety reporting, the protocol can specify that certain serious adverse events do not require immediate reporting. This allows the study to focus expedited reporting on events that truly need urgent attention, while other SAEs are captured through routine safety monitoring or periodic summaries. The correct choice reflects that the protocol may identify which SAEs do not need immediate notification to sponsors or regulators.

Driving this point home: expedited reporting is reserved for events that are serious, unexpected, and related to the investigational product, or otherwise require prompt action. Not all SAEs fall into that category, so the protocol may designate some as non-urgent. The other statements imply universal immediate reporting or no reporting at all, or reporting only at the end, which contradicts how safety reporting is actually structured in GCP.