Who is responsible for assessing and selecting service providers in clinical trials?

• A. The regulatory authority.
• B. The sponsor.
• C. The investigator.
• D. The ethics committee.

Answer: (B)

In clinical trials, the sponsor is responsible for selecting and assessing service providers. The sponsor initiates, funds, and oversees the study and must ensure that vendors such as CROs, laboratories, imaging centers, and other contractors are qualified to perform their assigned tasks in line with the protocol, GCP, and regulatory requirements. This includes conducting vendor qualification and due diligence, assessing capabilities and quality systems, and establishing contracts that specify oversight, monitoring, data integrity, and subject protection. The investigator runs the trial at the site under the sponsor’s oversight, the ethics committee reviews the protocol and informed consent, and regulatory authorities grant approvals and oversight, but they do not handle the day-to-day selection of service providers. Therefore, the sponsor holds the responsibility for assessing and selecting service providers.