How should investigational products be handled to ensure compliance?

• A. In a manner that aligns with treatment assignment and applicable regulations.
• B. According to the investigator's preference.
• C. Based on participant request.
• D. With no regulatory oversight.

Answer: (D)

Handling investigational products must follow the protocol and applicable regulations to protect participant safety and data integrity. This means ensuring proper receipt, storage under required conditions, labeling, and a documented chain of custody from the point of custody to administration and eventual destruction. The investigational product should be used strictly as assigned by the trial protocol and randomization, not altered by the investigator’s personal preference or by participant requests. Regulatory oversight is essential, with responsibilities shared among the sponsor, investigator, ethics committee/IRB, and relevant authorities to monitor compliance, documentation, and reporting. In short, IP handling is governed by the protocol and regulations, with robust accountability and oversight to prevent deviations that could affect safety, consent, or study validity.