Which statement best describes sponsor obligation in investigator selection?

• A. Investigators select themselves
• B. The Sponsor is responsible for selecting investigators/institutions
• C. The IRB selects investigators
• D. The Regulatory Authority selects investigators

Answer: (B)

In GCP, the sponsor bears the responsibility for selecting investigators and trial sites. This means the sponsor must identify and qualify investigators and institutions that have the appropriate qualifications, expertise, facilities, and resources to conduct the study in accordance with the protocol, GCP, and applicable regulations. The sponsor should verify that investigators have the necessary training, experience, and ability to enroll and follow participants, maintain required records, and ensure participant safety and data integrity. By taking charge of site and investigator selection, the sponsor can ensure consistent oversight, adequate monitoring, and proper implementation of the study across all sites. Investigators do not select themselves, the IRB does not choose investigators, and regulatory authorities do not select investigators, so the sponsor’s role here is essential and distinct.