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Investigational Drug Service

Investigational Drug Service

The Department of Pharmacy’s Investigational Drug Service provides broad, foundational support for clinical research activities at the Icahn School of Medicine at Mount Sinai and across the Mount Sinai Health System.

Operationally, the Investigational Drug Service is a research pharmacy that maintains the control and accountability of investigational products (U.S. Food and Drug Administration [FDA]-approved and non-approved) in compliance with regulations related to good clinical practices, good manufacturing practices, and other regulations and laws, as appropriate. We provide protocol review, procurement, accountability, temperature-controlled storage, order verification, and preparation/dispensation of investigational product, multi-site coordination, and education to institutional groups and investigators engaged in clinical research.

Our dedicated clinical pharmacy managers are available to consult with any investigator (or sponsor) to explore the logistics of conducting a clinical trial within the Mount Sinai Health System. To ensure the maximum benefit and safety for patients enrolled, the Investigational Drug Service establishes specific procedures and systems for each clinical trial.

All human subject trials requiring the use of medications must obtain authorization from the Investigational Drug Service prior to the final approval from the Program for the Protection of Human Subjects at Icahn Mount Sinai. Please note that these reviews occur concurrently.

To initiate our review of your protocol, begin by completing the Investigational Drug Service Review Form. Submit all relevant protocol and investigational product documents via Icahn Mount Sinai’s Institutional Review Board portal.

For further information on the Investigational Drug Service, please review our Information and Review Form Guidance.