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Information for Investigators

INITIATION OF A CLINICAL DRUG STUDY

The IDS request a copy of the Sponsor’s protocol and Investigator’s Drug Brochure. The Research Pharmacist will review the protocol, meet with sponsor representatives, the principal investigator, study coordinator, and other study personnel to assess the potential IDS requirements. An IDS budget will be developed for the investigator to adequately plan for all necessary pharmacy cost. The Pharmacy cost should be included in the PI’s study budget to the Sponsor. A copy of the protocol should be forwarded to the Research Pharmacist at:

Investigational Drug Service

Department of Pharmacy Services
Attn: Stephen Sitzlar
Room HC-201, Medical Center
Speed Sort: 0293

COST OF USING THE INVESTIGATIONAL DRUG SERVICE

The IDS operates on a break-even basis. It charges for its actual estimated costs and is expected to “break even“ at the end of the year. The IDS prepares budgets for each study regardless of the funding source. All IDS charges are negotiable and even studies with minimal financial support can be accommodated. The over-all cost for the IDS are broken down into several categories. At the end of the budget, everything is summarized as a TOTAL figure which can be inserted into the study budget or grant proposal. If a per-subject figure is needed, the TOTAL figure can be divided by the proposed number of subjects anticipated.   

Categories of cost are as follows:

• START-UP COST: A one-time charge at study initiation. This charge is incurred regardless of whether a subject is ever enrolled into the study. This includes the cost of preparing a preparation/dispensing procedure, planning or initiation meetings, staff in-services for pharmacists and technicians, and setting up computer codes.
• RANDOMIZATION: Per subject charge for list or telephone randomization
• PREPARATION AND DISPENSING: Varies depending on the type of medication (IV bag, IV syringe, oral, chemotherapy, gene therapy), the number of doses and duration of treatment.
• DRUG COST: The cost of any FDA approved drugs or supplies purchased by the IDS for the study
• INVENTORY AND RECORDKEEPING: This includes quality assurance, monitor visits, restocking and reordering as needed, and storage of used products.
• STUDY CLOSURE: Includes return or destruction of all remaining study materials, copies of records as needed, return of any special equipment which was provided, and records archival for up to 15 years.