The Tisch Cancer Institute

Clinical Trials Information for Investigators

Oversight and Review Process

The Tisch Cancer Institute (TCI) Clinical Trials Office (CCTO) has clinical research oversight over all cancer clinical research conducted at Mount Sinai. Cancer-related clinical research and trials are required to be reviewed by the Protocol Review and Monitoring Committee (PRMC). PRMC-approved projects are then reviewed by an Institutional Review Board (IRB). The CCTO works in conjunction with the Office of Research Services to facilitate research through a centralized infrastructure providing resources and expertise. 

The following Tisch Cancer Institute resources are available to investigators and research personnel.

  • ONBASE: The CCTO provides a central location for cancer protocols, a centralized database of protocol-specific data, and an updated list of active protocols for use by investigators. Onbase is an online system for retrieving key documents about our cancer clinical trials.
  • PRMS: All cancer-related clinical research studies at the Mount Sinai Health System are required to be reviewed and approved by the PRMS prior to submission to any Institutional Review Board.
  • Resource-Allocation Evaluation (RAE): Once a protocol is endorsed by the applicable Disease Focus Group (DFG) and given a priority score, the investigator can proceed with requesting CCTO resources for the direct conduct of the trial (eg: clinical research nurses and/or coordinators) by completing a Clinical Trial Feasibility form. Engaging RAE review early in the process by experienced CCTO staff improves accuracy of budgeting, addresses study logistics, reduces study time to activation, and improves the overall economics of clinical research.
  • Clinical Research Do's and Don’ts: This document aids in training of investigators and research personnel.
  • Training: If you plan to conduct research at Mount Sinai, you’ll need to complete training that complies with state and federal requirements.
  • Standard Operation Procedures: Policies are available for specific clinical research operations on the intranet.
  • Biostatistics Shared Resources: BSRF members participate actively in the design of new studies in basic science, clinical, epidemiological, survey and cancer prevention.

The following institutional resources are available to investigators:

  • How Do I: For investigators new to research, new to Mount Sinai, or embarking on a new project, this section provides answers, resources, and guidance to support you. Learn about starting your research, finding funding, submitting and managing grants and sponsored projects, obtaining necessary approvals, commercializing discoveries, and access to required training.
  • Getting Started: Find virtual guidance, training links, resource search tools, and other resources to get you started with your project at Mount Sinai.
  • Office of Research Service (ORS): Dean's Office of Research Services (ORS) has been developed to facilitate the conduct of research through a centralized infrastructure. ORS is an integrated office available to assist investigators and research personnel with regulatory oversight requirements and administrative processes for protocol development and grant submissions.
  • Institutional Research Resources: The one-page documents illustrate the research administration offices (e.g., IRB, Grants and Contracts, etc.) and research services that are available to support investigators and their research teams. Contact lists are also provided. Be sure to double-click on the name of the office or service that you would like to learn more about to visit that particular website.