What population is typically used for safety analyses in a GCP-compliant trial?

• A. Per-protocol population only
• B. Efficacy population only
• C. Safety population including all randomized participants who received at least one dose
• D. Only those who completed the trial

Answer: (C)

In safety analyses, you want to capture every potential adverse effect connected to exposure to the investigational product. That means including all participants who were randomized and actually received at least one dose of the study drug. This safety population, sometimes called the safety analysis set, ensures that adverse events are not missed from those who dropped out early or didn’t fully adhere.

Other approaches focus on efficacy or on those who completed the trial, which can bias safety signals by excluding people who were exposed to the drug but didn’t finish or didn’t follow the protocol. Hence, the correct choice is the safety population including all randomized participants who received at least one dose.