What is the requirement for informing all persons assisting with the trial about the protocol and duties?

• A. It is optional if they are experienced.
• B. All persons assisting with the trial should be adequately informed about the protocol, the investigational products, and their trial-related duties and functions.
• C. Only the primary investigators need to know the protocol.
• D. Informing staff is required only if the trial is high risk.

Answer: (B)

The requirement being tested is that everyone involved in the trial must be adequately informed about the protocol, the investigational products, and their trial-related duties and functions. This ensures that all personnel understand the study procedures, their own responsibilities, and safety considerations, which supports participant protection and reliable data.

This training and information flow is mandated by GCP at the start of the trial and whenever protocol or procedures change, so every person helping with the trial can perform their tasks correctly and consistently, regardless of their prior experience or the perceived risk level of the study.

Saying it’s optional for experienced staff, limited only to primary investigators, or required only for high-risk trials would miss the obligation to inform and train all personnel involved in trial-related activities.