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The UAB Hospital Investigational Drug Service in the hospital's Department of Pharmacy stores and distributes investigational drugs prescribed for patients hospitalized at UAB Hospital. Our investigational drug pharmacist can assist you in planning and executing clinical trials using investigational drugs. The pharmacist can also assist in the randomization and blinding process. Note: Commercially available drugs may be considered investigational if the drug is obtained by the investigator outside of the normal hospital purchasing process.

Investigators are strongly encouraged to meet with the investigational drug pharmacist prior to enrolling subjects in order to develop study-specific orders and review drug dispensing processes. Fees to assist investigators are negotiable; however, this should be done before the study is ready to be implemented.

Pharmacy Facility

We provide limited-access, locked ambient refrigerator and freezer storage for investigational drugs within the central, storeroom, and research pharmacy areas of North Pavilion.

We use appropriate workspaces within the Central Pharmacy 797 clean room for the preparation of injectable doses.

We follow Alabama State Board of Pharmacy laws regarding space, storage and labeling.

Ambient temperature is thermostatically controlled to allow for a temperature range of 68°F (20°C) to 77°F (25°C). Limited space is available for storing drugs at 2-8°C, -20°C, and -80°C. Within-range documentation is provided daily.


Study Approval

Investigators must submit protocols to the pharmacy department at the time the study is submitted to the IRB. A completed Release of Drugs for Human Use Form (FOR217) must accompany the protocol. The current version of this form is available on the IRB website. Completing this brief form provides needed budgetary and logistical information not always contained in a protocol.


Fees

When human use studies are reviewed the current fees that are recognized as applicable will be posted on the Release of Drugs for Human Use Form (FOR217).

For questions related to fees, please email Michael H. Geerts, Pharm.D., Department of Pharmacy or call 205-934-7865.


Subject Enrollment

In order to ensure that drug supplies are available at the time a subject is enrolled, the investigator or the designee must contact the investigational drug pharmacist when screening candidates for a study.


Drug Handling Activities

Prior to dispensing, the pharmacist(s) must be notified in writing of the patient’s enrollment and will be provided a written order. Drug storage, inventory maintenance, preparation and dispensing activities are protocol-specific. Documentation of dispensing will be maintained in the pharmacy until after the study is closed. Records will be transferred to the investigator after the completion of the study


Destruction of Drugs

Immediately after a dose or a prescription is prepared and dispensed, supplies used in the preparation are handled as hazardous waste. Unused drug supplies may be destroyed at the UAB Incinerator. A destruction fee will be assessed.