Who is responsible for determining the causality of a serious adverse event in a clinical trial?

The principal investigator is primarily responsible for determining the causality of a serious adverse event (SAE) in a clinical trial. This role involves overseeing the conduct of the trial and ensuring the safety and well-being of the participants. The principal investigator must assess whether the SAE is related to the investigational product or the study protocol, based on clinical judgment and a thorough understanding of the trial's objectives and procedures.

Causality determination involves a careful evaluation of the circumstances surrounding the adverse event, including the timing of the event in relation to the administration of the study drug, background medical history, and any other potential contributing factors. The principal investigator collaborates with the study team, but ultimately, the responsibility for this crucial assessment lies with them, as they have the expertise and authority to make informed clinical decisions regarding participant safety.

The other roles in a clinical trial, such as the emergency department nurse, the pharmacist, and the study coordinator, may provide important support and information, but they do not have the final authority to determine causality for SAEs. Their involvement is essential for managing care and reporting but does not equate to the primary responsibility held by the principal investigator in this context.