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Informed Consent Document Templates

SECTION 26

Investigational Drug Service/Clinical Research Pharmacy

All medications (drugs or biologics) including placebo(s) used in clinical research studies must be labeled, stored and dispensed according to federal, state and institutional policies and regulations. A completed HAC Form 104, Research Medication Data Sheet, describing key information about the medication must be submitted to, and approved by, the HAC.  If the research medication is commercially available, attach a package insert in lieu of completing administration and side effects information.

The Medical College of Georgia Health System, Department of Pharmacy, Investigational Drug Service/Clinical Research Pharmacy is responsible for the receipt, dispensing, accountability and record keeping for all investigational drugs used in research studies involving humans on the MCG campus including Georgia War Veterans Nursing Home (GWVNH).  

All medications provided to patients at the Veterans Affairs Medical Center (VAMC) Hospital will be dispensed through the VA Hospital Pharmacy.

The study sponsor must be informed that all medications used in clinical research studies are to be shipped directly to the respective pharmacy.  This information must be noted on the FDA Form 1572.  Also, the drug shipment address for MCG must be placed in Section 3 of the Form 1572 as follows:

Medical College of Georgia Hospital and Clinics
ATTN:  Clinical Research Pharmacy
1120 15th St., BI-2101
Augusta, GA  30912

If a research subject misses an appointment and the investigational medication was dispensed to the research team member, the medication must be returned to the Clinical Research Pharmacy immediately. 

If a research subject returns investigational medication (packets, bottles, tablets, capsules, etc.), the items must be returned to the Clinical Research Pharmacy immediately.

Please note that the MCGHI Clinical Research Pharmacy does charge for their services.  For more information, call 706-721-0802.

The Clinical Research Pharmacist serves on the HAC.  The Committee does not feel that it is a conflict of interest.

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February 20, 2007