In multi-center trials, who is responsible for organization and selection of coordinating investigator(s)?

• A. Sponsor
• B. Investigators
• C. IRB
• D. Regulatory Authority

Answer: (D)

The sponsor is responsible for organizing and selecting coordinating investigator(s) in a multi-center trial. The sponsor oversees the overall conduct of the study, defines the study structure, and appoints a coordinating investigator (or a team) to manage trial activities across all participating sites. This role ensures consistent procedures, training, data collection, safety reporting, and communication with site investigators, so everyone works toward the same protocol and quality standards. The site investigators carry out the study at their own sites under the guidance of the coordinating investigator, while IRBs/ECs provide ethical review at each site, and regulatory authorities oversee compliance and approvals rather than organizing the trial’s coordinating structure.