The Investigational Drug Service (IDS) is a team of specially-trained clinical pharmacists and certified pharmacy technicians. The IDS team supports human clinical research involving investigational products and is dedicated to helping investigators accomplish research goals while maintaining compliance with all applicable standards and regulations.
Location
The Research Pharmacy is a licensed pharmacy that dispenses medications used in inpatient and ambulatory clinical trials performed by investigators at The George Washington University.
Investigational Drug Service at The George Washington University
George Washington Medical Faculty Associates (GW MFA)
2150 Pennsylvania Ave NW, Suite 6A-404
Washington, DC 20037
Hours: Monday through Friday, 8:00 AM to 4:00 PM
Phone: 202-741-3624
Fax: 202-741-3621
Email: ids [at] mfa [dot] gwu [dot] edu (ids[at]mfa[dot]gwu[dot]edu) (preferred method of contact)
Overview of Services Provided
In addition to drug preparation and dispensing for outpatient and inpatient areas, the IDS team can provide an array of services including:
- Comprehensive clinical review of all medication orders by a Clinical Pharmacist
- Assessment of monitoring parameters
- Dose adjustments and dose calculations
- Drug-interaction analysis
- Provision of drug information to patients and healthcare team
- Assistance with clinical trial development
- Assist with protocol development (for investigator-initiated studies)
- Protocol review for feasibility
- Development of a pharmacy budget and invoice
- Review of EPIC/Beacon order sets
- Study drug accountability
- Drug and supply procurement, as needed
- Participation in initial, interim, and close-out sponsor visits
- Maintenance of blinding for blinded studies
- Record keeping and retention
- Quality assurance monitoring
Pharmacy Inventory Management & Temperature Control
Inventory Management
The Research Pharmacy can provide inventory management for investigational agents, which includes:
- Compliance with sponsor, institutional, state and federal regulations for documentation
- Inventory monitoring
- USP 795, USP 797, and USP 800 compliant preparation and dispensation of investigational product
- Destruction of investigational product
- Tracking of inventory expiration dates and re-test dates
Temperature Control
The Research Pharmacy has the capacity to store investigational product in refrigerators (2-8°C), freezers (-20°C), deep freezers (-70°C) and at room temperature (20-25°C). To ensure the proper storage of investigational and commercially available drugs dispensed as part of a clinical trial, the IDS team has established procedures for temperature monitoring. Temperatures for drugs stored within the research pharmacy are monitored 24/7 by means of a primary data logger in addition to a back-up data logger. In the event of any monitored temperature excursions, the IDS team is immediately alerted.
Drug Disposition
Disposition of study drugs will primarily be handled in accordance with applicable Federal and State regulations, Good Clinical Practice Guidelines, institutional policies, and the sponsor’s requirements. All specifics surrounding drug destruction can be found within the GW MFA IDS SOP for Investigational Drug Disposal and Destruction. The most updated version can be found on the IDS Pharmacy Policies page.
Research Pharmacy Fees
During the protocol development phase, the IDS team develops budgets to estimate the costs required to cover pharmacy expenses. Study teams should contact the IDS pharmacy early in the process to create an estimated budget prior to completion of the overall study budget. Standard fees include administrative set-up, inventory management, dispensing fees, monitoring fees, and protocol close-out. Additional fees may be charged depending on the complexity of the protocol, such as 24/7 enrollment fees (if GWUH pharmacy support is required off-hours), study drug compounding and blinding service fees, direct-to-patient shipping fees, and drug/supply fees. A proposed budget is an estimate, and if substantial changes are made to the protocol the budget may require revisions. Please contact the IDS team directly for additional information on current fee schedules.