Labeling of investigational product(s) must comply with what?

• A. Company style guidelines only
• B. No labeling requirements
• C. Comply with applicable regulatory requirement(s)
• D. Required to be handwritten only

Answer: (C)

Labeling of investigational product(s) must follow applicable regulatory requirement(s). In clinical trials, regulators require labels that clearly identify the product, its trial and sponsor information, and how it should be stored and used. A properly labeled IP minimizes mix-ups, ensures correct administration, and supports traceability and safety monitoring. Labels should include essential details such as product name, trial/identifier, batch/lot number, expiration date, storage conditions, and any handling or administration instructions, and they must be in the language required for the country where the trial takes place. Importantly, labeling must be approved by the sponsor and regulatory authorities and should not be altered or handwritten in an unapproved way.