What should an investigator do upon learning that a subject has been in a car crash resulting in injury?

An investigator is responsible for ensuring the safety and well-being of study subjects and must report all relevant adverse events that occur during a clinical trial. In this scenario, upon learning that a subject has been in a car crash resulting in injury, the correct course of action is to document the event and report both injuries as adverse events.

This approach aligns with Good Clinical Practice (GCP) guidelines, which require that any significant health events involving study subjects are captured thoroughly, regardless of whether they are directly related to the treatment or not. The goal of reporting such events is to monitor the overall safety profile of the study drug and to protect future subjects.

By documenting the event and reporting it, the investigator ensures that the sponsor and regulatory authorities have complete information regarding the health of the study subjects, facilitating a comprehensive risk assessment and ensuring the integrity of the clinical trial process. This accountability is crucial not only for the immediate safety of subjects but also for the ongoing evaluation of the treatment being studied.