What should be documented regarding the responsibilities of coordinating and participating investigators before starting the trial?

• A. They should be documented.
• B. They need not be documented.
• C. They can be informal verbal arrangements.
• D. They should be approved after trial start.

Answer: (A)

Before starting a trial, the responsibilities of the coordinating investigator and the participating investigators must be documented in a written arrangement. This lays out who is responsible for each key task—protocol compliance, obtaining informed consent, supervising trial procedures, data collection and documentation, safety reporting, and how duties are delegated to trained staff—and defines how they interact with the sponsor. Having these duties in writing ensures clear accountability, proper training, and appropriate delegation prior to enrollment, which is required by GCP. Verbal arrangements or delaying documentation until after initiation do not meet regulatory expectations.