Who is responsible for selecting investigators/institutions?

• A. The Investigator
• B. The Sponsor
• C. The IRB
• D. The Regulatory Authority

Answer: (B)

The sponsor is responsible for selecting investigators and study sites. This responsibility ensures that qualified investigators and adequate facilities are in place to conduct the trial according to the protocol and GCP, with capable personnel, proper resources, and the ability to maintain data integrity and participant safety. The investigator at the site then executes the study under contract with the sponsor, while the IRB/IEC focuses on ethics and participant protection, and regulatory authorities oversee compliance and approvals rather than making site or investigator selections. So, the sponsor’s role in identifying and qualifying investigators and institutions best fits how trials are set up and governed.