Welcome to the Sylvester Comprehensive Cancer Center’s Clinical Research Services (CRS). This division forms a collection of resources to aid in the research initiatives at Sylvester. These services provide the investigator with the essentials to conduct research within the Cancer Center.
Clinical Research Services Mission Statement:
The mission of Sylvester Clinical Research Services is to provide exceptional support to Sylvester clinical investigators to facilitate leading-edge clinical research with the highest levels of expertise, compliance, and integrity to improve the lives of cancer patients.
CRS provides Clinical Protocol and Data Management (CPDM) support and a centralized office for the conduct of cancer clinical trials at University of Miami (UM). The purpose of the CRS is to provide an effective and efficient infrastructure to support Sylvester investigators in developing, implementing, and reporting on all UM cancer clinical research studies.
The specific aims of the Sylvester CRS are to:
- Serve as a central clinical research information repository that facilitates Center-wide communications, subject accrual tracking, and monitoring of the progression for all clinical studies from inception to final publication
- Assist Sylvester investigators in the timely activation and administration of clinical studies, including the preparations and communications required for scientific, ethical, financial, and operational reviews as well as ongoing support for annual regulatory reviews
- Assist investigators in screening and enrolling patients for clinical research studies
- Coordinate and ensure the completion of patient-specific study requirements
- Provide data management support for clinical research studies
- Prepare medical and research records for internal and external quality and compliance audits
- Provide training and education pertaining to the best practices in conducting clinical studies to clinical and CRS staff and new investigators
- Communicate the availability of clinical studies to Sylvester physicians, referring physicians, and the public
- Ensure that supported trials are conducted in compliance with institutional and federal regulations
Investigator resources include:
- Protocol Development
- Medical Study Start-Up
- Investigator New Drug (IND) Support
- Feasibility Review Committee (FRC)
- Protocol Review and Monitoring Committee (PRMC)
- Data and Safety Monitoring Committee (DSMC)
- Clinical Research Operations and Regulatory Support (CRORS)
- Research Compliance and Quality Assurance (RCQA)
Jonathan C. Trent, M.D., Ph.D.
Associate Director of Clinical Research
Helen Peck, R.N., M.A., O.C.N., C.C.R.P.
Executive Director, Clinical Research Services