What is required to ensure timely delivery of the investigational product to investigators?

• A. The sponsor ensures timely delivery of IP to investigators
• B. Investigators arrange delivery times
• C. Delivery timing is approved by regulatory authority
• D. Delivery times are not important

Answer: (A)

Timely delivery of the investigational product to investigators is the sponsor’s responsibility. In GCP, the sponsor plans, procures, ships, and tracks IP to sites, ensuring it arrives on schedule, arrives in the correct condition, and is documented with proper lot and chain-of-custody records. This coordination keeps the study on its timeline and helps protect participant safety and data integrity. Investigators handle IP once it arrives at the site, following protocol and storage requirements, but they do not control shipment timing. Regulatory authorities oversee the overall trial and approvals, not the day-to-day delivery schedule. Delivery times are important; assuming otherwise would risk protocol deviations and interruptions.