Which statement about the investigational product and protocol is true?

• A. Investigational products should be used in accordance with the approved protocol.
• B. GMP is optional for investigational products.
• C. The protocol is independent of GMP.
• D. Investigational products need not follow GMP.

Answer: (A)

In clinical trials, the investigational product must be used exactly as the protocol prescribes, and its quality must be ensured under GMP. The protocol lays out how the product should be administered—dose, route, timing, duration, and safety monitoring—so following it makes the trial conduct scientifically valid and protects participants. GMP, on the other hand, governs how the product is manufactured, stored, labeled, and distributed to ensure its identity, strength, quality, and purity. Both pieces are essential: you can’t reliably study a product that isn’t manufactured to quality standards, and you can’t responsibly apply a protocol without a properly controlled product.

GMP is not optional for investigational products, and the protocol is not independent of GMP—their requirements together safeguard participant safety and data integrity.