When tasks are delegated in a clinical trial, who remains accountable for those activities?

• A. The delegated party becomes solely responsible.
• B. No one is responsible.
• C. The sponsor or investigator retains overall responsibility for their respective activities.
• D. The IRB takes over responsibility.

Answer: (C)

Delegation doesn't wipe away accountability. In good clinical practice, you can assign specific tasks to qualified people or organizations, but the sponsor or investigator remains ultimately responsible for the conduct of those activities. They must ensure that delegated tasks are performed correctly, by trained personnel, with proper oversight and documentation. If anything goes wrong, the sponsor or investigator must address it and maintain control over the trial’s integrity and participant safety. The IRB protects participants’ rights and welfare, but it does not take over day-to-day trial responsibility. So, the person or entity overseeing the study retains overall accountability for the activities they delegate.