Who may be designated to maintain records of the product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s)?

• A. The sponsor alone.
• B. The investigator/institution and/or a pharmacist or other appropriate individual designated by the investigator/institution, under supervision.
• C. The trial subjects themselves.
• D. Any site staff with no supervision.

Answer: (B)

Drug accountability and documentation for investigational products. Records of delivery to the trial site, on-site inventory, use by each subject, and the return or disposal of unused product must be kept accurately for traceability and regulatory compliance. While the sponsor provides the product, the investigator retains overall responsibility and may designate a pharmacist or another appropriate individual to maintain these records under the investigator’s supervision. This delegated arrangement ensures proper oversight, protocol adherence, and auditable documentation. Delegating to someone without supervision or to trial subjects themselves would undermine accountability, and sponsor-only record-keeping at the site is not appropriate. Therefore, the designated person can be the investigator or institution and/or a pharmacist or other appropriate individual designated by the investigator/institution, under supervision.