What is the primary purpose of the Investigational Drugs Service (IDS)?

• A. Procure, manage, prepare, dispense and dispose of investigational drugs in accordance with protocol and state and federal regulations governing investigational drug activities.
• B. Develop marketing strategies for investigational drugs.
• C. Monitor patient satisfaction with clinical trials.
• D. Maintain hospital inventory of non-investigational medications.

Answer: (A)

Ensuring proper handling and regulatory compliance of investigational drugs used in clinical trials. The Investigational Drugs Service procures the study drug, securely stores and organizes it, prepares doses (often under blinded conditions), dispenses it to enrolled patients, and disposes of any unused or waste material, all in strict alignment with the trial protocol and applicable state and federal regulations. This includes maintaining accurate documentation, preserving chain of custody, monitoring storage conditions, and ensuring the drug is used only for the approved study and participants. IDS activities are coordinated with investigators, pharmacy staff, and regulatory bodies to meet IND requirements, IRB approvals, and Good Clinical Practice standards, which protects patient safety and maintains trial integrity. Other tasks like marketing investigational products, measuring patient satisfaction, or stocking only non-investigational meds fall outside this service’s primary focus.