Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?

In a multi-center clinical trial, the Sponsor-Investigator holds ultimate responsibility for the overall conduct of the study. This includes ensuring compliance with the protocol, maintaining data integrity, and overseeing all participating sites. The Sponsor-Investigator must ensure that each site follows the same procedures and standards to maintain consistency across the trial.

According to GCP guidelines, the Sponsor-Investigator must take responsibility for all aspects of a multi-center trial, including site coordination and data management.

"The Sponsor-Investigator assumes ultimate responsibility for the conduct of a multi-center clinical trial, ensuring protocol compliance and data consistency."

Objectives:

Maintain accountability across multi-center sites.

Ensure uniformity in trial conduct.