In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions...

The Principal Investigator (PI) holds ultimate responsibility for ensuring that all study-related functions are conducted by qualified and trained personnel. The PI must verify that staff have the necessary qualifications and training to perform their assigned tasks as outlined in the protocol. This responsibility is crucial for maintaining compliance with GCP and ensuring data integrity.

According to GCP guidelines, the PI must ensure that all staff assisting with the trial are adequately trained and qualified for their roles.

"The investigator is responsible for ensuring that all persons assisting with the trial are qualified by education, training, and experience to perform their respective tasks."

Objectives:

Maintain compliance with GCP requirements.

Ensure qualified personnel conduct study tasks.