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VCU Medical Center Investigational Drug Pharmacy

Investigational Drug Service at VCUMC. Approximately 135 active studies (2006)Average of 15,000 total doses per month50 IV doses per month30 chemo doses per month300 prescriptions per month5 new studies started per month. Investigational Drug Service at VCUMC. Staffed by 1.5 FTE RPh's and 1 FTE

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VCU Medical Center Investigational Drug Pharmacy

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    1. VCU Medical Center Investigational Drug Pharmacy http://www.phm.vcu.edu/ids/index.htm Robin Sculthorpe, RPh, B.S.

    2. Investigational Drug Service at VCUMC Approximately 135 active studies (2006) Average of 15,000 total doses per month 50 IV doses per month 30 chemo doses per month 300 prescriptions per month 5 new studies started per month

    3. Investigational Drug Service at VCUMC Staffed by 1.5 FTE RPh’s and 1 FTE technician Monday-Friday 9-5 After-hours dispensing by the ICU pharmacy 24-hour coverage by IDS Pharmacy via pager Contact: Robin Sculthorpe, RPh (rsculthorpe@mcvh-vcu.edu) Phone: 828-7901 Fax: 828-4402 PO Box: 980042

    4. Functions of the IDS Pharmacy Inventory Control Storage Accountability Storage of Records Packaging and Labeling of investigational drugs Meeting with study monitors

    5. Functions of the IDS Pharmacy Participation on the IRB committee Compounding of blinded doses Participation in protocol development Participation in protocol audits Drug “Locator” sheets Drug “Fact” sheets

    6. IDS Protocol Requirements Prior to opening a study, the IDS Pharmacy requires: A copy of the current protocol. A copy of the Investigator Drug Brochure (IDB) if the drug is not commercially-available. A copy of the FDA 1572 Statement of the Investigator (if applicable) or a list of physicians authorized to prescribe for the study.

    7. IDS Protocol Requirements (Continued) Prior to opening a study, the IDS Pharmacy requires: A copy of the IRB approval letter A signed copy of the IDS Charge Estimate with valid Banner index code. An estimate of the number of subjects to be enrolled and the expected duration of the study. Approximately 2 weeks to prepare for dispensing.

    8. IDS Billing The IDS Pharmacy bills investigators for its services: Study Initiation (“Startup”) fee Monthly Administration fee Dispensing fees Fees for special services Fees plus cost of acquisition of commercially-available drug(s) to be used in a study

    9. IDS Billing The IDS Pharmacy bills on a monthly basis. Bills are generated by the IDS Pharmacy and sent to the Pharmacy Business Manager for processing. Pharmacy Business Manager: Donald Price 828-5711 Box 980042 Dprice@mcvh-vcu.edu If the index code changes for a study, please let us know.

    10. IDS Billing Following verification that the index code is valid, the funds are transferred electronically via an IDT. IDS billing continues until the study is closed. The IDS Pharmacy requires written notification of study closure and final accountability of any remaining study drug(s) before the study is closed.

    11. Miscellaneous Shipping Address: VCU Health System Investigational Pharmacy / Robin Sculthorpe North Hospital / G-121 1300 East Marshall Street Richmond, VA 23298-5028

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