Which of the following documents is maintained by a PI to ensure compliance with sponsor...

The PI is responsible for maintaining training records of site personnel, which demonstrate compliance with the sponsor’s requirements for conducting the trial. Proper documentation of training ensures that all team members are knowledgeable about the protocol and study procedures.

GCP guidelines mandate that the PI maintains adequate records to demonstrate that all personnel involved in the study are properly trained and qualified.

"Training records of site personnel must be maintained to verify that the team is adequately trained on the protocol and their specific responsibilities."

Objectives:

Maintain training compliance.

Document personnel qualifications for quality assurance.