In an investigational drug study, what is the pharmacist's role?

• A. Conducting patient visits
• B. Managing control and distribution of investigational drugs
• C. Marketing the drug
• D. Inspecting labs

Answer: (B)

The main idea is that the pharmacist acts as the steward of investigational drugs, ensuring strict control and proper distribution throughout a study. In practice, this means running the investigational drug service: receiving the investigational product, securely storing it under the required conditions, and maintaining a meticulous chain of custody and inventory. The pharmacist dispenses the drug to investigators for eligible participants exactly as the protocol specifies, records doses and lot numbers, reconciles remaining stock, and handles the return or destruction of unused medication according to approved procedures. This role also involves ensuring labeling, regulatory compliance (such as IND requirements), and timely documentation for audits and safety reporting, all while protecting blinding and protocol integrity when applicable. Tasks like conducting patient visits, marketing the drug, or inspecting labs fall outside this function and are handled by other members of the study team.