The Medicine Clinical Trials Office (MCTO) currently manages more than 100 clinical trials within the Department of Medicine at the Icahn School of Medicine at Mount Sinai. Working closely with institutional committees, including the Program for the Protection of Human Subjects, the MCTO maintains compliance with all institutional, state and federal regulations throughout the course of each study. The administrative infrastructure of a Clinical Trials Office allows our investigators to obtain approval for studies in a timely manner and supports institutional compliance with regulatory requirements. Additionally, Principal Investigators and their research teams are thereby able to focus on the scientific rigor and patient care side of research.
Specifically, the MCTO provides comprehensive services to support clinical investigators with:
- Document preparation and submission to internal Department of Medicine Protocol Review Committee.
- Protocol feasibility determination in collaboration with Investigators.
- Financial Management throughout the lifecycle of the study.
- Collaboration with sponsors and/or contract research organizations to prepare all pre-award documentation, including regulatory submissions.
- Centralized processes and resources through 4 Core Teams: Regulatory Compliance, Financial Management, Clinical Coordination, and Research Operations.
- Investigator Initiated Trial (IIT) development, activation, and management.