How should investigational product(s) be used according to the investigator's responsibility?

• A. In any manner as long as patient is informed.
• B. Only in accordance with the approved protocol.
• C. Only for non-clinical purposes.
• D. Can be repurposed for other trials.

Answer: (B)

Using investigational product strictly as described in the approved protocol is essential. The protocol defines who can receive the product, the exact dosing, route of administration, timing, monitoring, and all handling and safety procedures. This keeps participant safety first and ensures the trial data are reliable and interpretable. Any use outside (or modification of) the protocol introduces risks to subjects and can bias results, and would require proper approvals and amendments.

Informed consent alone does not authorize deviations from the protocol, so using the product in any other manner is inappropriate. Using the product for non-clinical purposes is outside the trial’s scope, and repurposing it for other trials would violate the current protocol and regulatory approvals.