Prior to supplying investigational product to a trial site, what must the sponsor obtain?

• A. All required documentation
• B. Appointment of a monitor
• C. A market license
• D. Insurance coverage

Answer: (A)

Before shipping investigational product to a trial site, the sponsor must have all required documentation in place. This ensures the site is legally and ethically authorized to conduct the study and that there are complete records to support the trial's conduct, safety, and accountability. Essential items typically include regulatory approvals and ethics committee/IRB clearance, the protocol and any amendments, the investigator brochure, informed consent forms, and site-specific documents like the delegation of authority log, investigator qualifications, and the signed investigator agreement. Having everything ready up front protects participants, supports proper monitoring and auditing, and keeps the trial in compliance with GCP. Without complete documentation, providing the investigational product would be inappropriate and potentially unsafe.