How should investigational products be used in clinical trials?

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Investigational products must be used only as described in the study protocol and related trial documents. The protocol defines the exact dose, route, schedule, duration, and all handling steps, including storage, labeling, dispensing, and accountability. Supporting trial documents—such as the investigator brochure, informed consent form, standard operating procedures, and monitoring plans—provide additional safety and operational instructions. Sticking to these documents protects participant safety and ensures the integrity and reliability of the data. Deviations are not acceptable unless they’re formally approved as amendments or documented deviations with proper oversight. Using the product as the investigator wishes, based on personal judgment, or randomly without a protocol would violate good clinical practice and regulatory requirements.