Handling of Investigational or Unlicensed Test Articles (Drugs)- PRO121   

Procedure
 

Investigator Responsibilities

• Submits to the pharmacy for all protocols using investigational or commercially available drugs:
  • A copy of the sponsor’s protocol;
  • Investigator’s Brochure for IND studies; and
  • A completed and signed FOR217 (UAB) or FOR218 (TCHA) Release of Drugs for Human Research Use form, as applicable.
• Designates personnel who may administer the medication and ensures they have the appropriate training to administer the medication safely.
• Designates where the study drug or test article will be shipped and stored.
• Describes the dispensing procedures (i.e., written physician order or prescription).
• Indicates the mechanism by which the pharmacy will be reimbursed for services.
• Submits the executed Release of Drugs for Human Research Use form together with the IRB submission.
• Completes the IRB application eForm (FOR200), to provide appropriate information requested for investigational drugs.

Pharmacy Responsibilities

• Reviews the investigator’s protocol and the Release of Drugs for Human Research Use form to ensure the procurement, storage, preparation, distribution and control of the drug is acceptable under applicable UAB Hospital standards (see SUP407 Patient Participation in Research, Investigation, or Clinical Trials;  SUP408 Investigational Drugs, Handling and Dispensing; SUP409 PCIR Outpatient Clinic Medication Orders).
• Calculates the fee per dose or course for the investigational drug or test article to be charged to the patient, grant, or other source.
• Assists the investigator in the proper storage and distribution of the drug.
• Signs the approved Release of Drugs for Human Research Use form and returns it to the investigator.
• Refers to the Investigational Drug formulary to provide a central agency in the hospital for information on and supply of investigational drugs.
• Prepares and labels drug or test article being dispensed.
• Records an entry of all doses received, dispensed, unused, returned and destroyed in the Investigational Drug Inventory/Dispensing Log.
• Performs inventory checks on stock at regular intervals.
• Maintains records for a period of no less than two years after FDA approval/IND termination or longer, if required by the sponsor, in accordance with 21 CFR 312.62.

OIRB Responsibilities

Reviewing Staff:

• Reviews and verifies the Release of Drugs for Human Research Use form is completed and signed by both the investigator and the Director of the Pharmacy.
• Does not issue approval until the Release of Drugs for Human Research Use form is signed and approved by pharmacy and received by the OIRB.

IRB Responsibilities

• Reviews the IRB application eForm and personnel eForm to ensure that the investigator or designated personnel are qualified to dispense and/or administer investigational drugs.