Investigational Drug Service (IDS)
The Investigational Drug Service (IDS) at the University of Washington Medical Center (UWMC), Harborview Medical Center (HMC) and Seattle Cancer Care Alliance (SCCA) manages medications used on clinical trials conducted at these facilities. The IDS provides accountability, handling, storage, and control of investigational drugs and assures compliance with the standards of the FDA and of the study sponsor. The IDS works with investigators and with the study sponsors, providing services that include:
Ordering and receiving study drug. IDS will assume responsibility for all aspects of ordering and receiving study drug.
Maintaining drug inventories and patient dispensing records. IDS will maintain accurate records of study drugs received. IDS works with the investigators to develop dispensing procedures that comply with FDA, sponsor and medical center guidelines. Drug accountability and patient dispensing records will be available to study sponsors, investigators, and the FDA for review.
Providing secured storage of study drug. The secured facilities of the Department of Pharmacy are utilized to insure proper storage of study drugs as required by federal regulations and by study sponsors. IDS maintains freezer and refrigerator space that is monitored and alarmed to ensure proper storage conditions for investigational medications.
Labeling and packaging of study drug for patient use. Study drugs will be packaged and labeled for dispensing to study subjects in accordance with sponsor guidelines, federal and state law. Study drugs are dispensed through the established drug distribution systems of the Department of Pharmacy.
Blinding and randomization procedures. IDS will assist investigators in the development of randomization schedules and insure appropriate blinding as required by study protocols.
Providing drug information. IDS will provide health professionals with drug information regarding investigational drugs, including: adverse effects, contraindications, administration guidelines, stability, compatibility, and drug interactions
Final Drug Disposition. IDS will assume responsibility for return or disposal of unused or expired study drugs and will maintain records of these transactions.
Additional Services are available upon request including:
- Patient monitoring
- Development of patient education materials
- Assisting in emergency use protocols
- Coordination of services between UWMC and other area institutions or Coordination with other sites of collaboration on multi-site research protocols.