The Department of Pharmacy maintains an Investigational Drug Service (IDS) to support research activities at Icahn School of Medicine. The IDS is a research pharmacy charged with maintaining the control and accountability of investigational agents (FDA approved and non-approved) in compliance with Good Clinical Practices (GCPs), Good Manufacturing Practices (GMPs) and other regulations and laws as appropriate. The IDS provides dedicated research support including protocol review, storage, preparation, dispensing and education to groups and investigators engaged in research.
The IDS sets up specific procedures and systems for each clinical trial to assure maximum benefit and safety for patients enrolled in studies. The clinical coordinators are available to consult with any investigator or sponsor to discuss the logistics of conducting their trial at Mount Sinai.
All human subject trials requiring the use of medications must get authorization from the IDS prior to Program for the Protection of Human Subjects (PPHS) final approval (IDS and PPHS reviews occur concurrently). To initiate the IDS review of your protocol, please complete the IDS Review Form. Submit the signed form along with the sponsors protocol, Investigators Brochure, PPHS Form 211, Protocol Template, and Informed Consent template to the Pharmacy Directors Office, Annenberg B2, Rm 214.