Main Campus Clinical Trials Coordination Unit (CTCU)
The main campus CTCU provides clinical coordination and data management services for all active clinical trials (open and closed to accrual). As the primary resource for directing studies, Clinical Research Coordinators (CRCs) act as the liaison between investigators, primary care providers, study subjects, and the study sponsor. In conjunction with the investigator, CRCs and data managers screen, enroll study subjects, coordinate study related care of patients, ensure study compliance, closely monitor patients actively receiving study treatment, and capture and report data during active treatment and follow-up of patients. All CTCU staff are required to have an in-depth knowledge of protocol requirements and Good Clinical Practices as set forth by federal regulations and the International Council for Harmonization (ICH).
Satellite Services
CTCU provides research support at four satellite sites which are located both north and south of the Downtown Miami Campus. The satellite sites served by Sylvester CTCU are: Deerfield Beach, Plantation, Coral Springs, Kendall, and Coral Gables.
Regulatory Affairs
Regulatory Affairs is a centralized resource within the CTCU providing support services for all aspects of research compliance and integrity. The Regulatory Affairs support includes timely initiation and completion of study activities, Investigational New Drug (IND) preparation, and post activation support. The regulatory staff provide technical and administrative support from initial clinical trial submission to the Protocol Review and Monitoring Committee (PRMC) and Institutional Review Board (IRB) through study termination.
Pre-activation:
- Protocol Development
The Protocol Development Office is housed within the regulatory division and assists investigators with designing and developing interventional clinical trials. Support is available for investigators at any stage of a research project's development, including laying the groundwork for a new proposal.
- Study Start Up
Study Start Up (SSU) serves as a liaison between the sponsor, Pl and study team throughout the activation process. SSU regulatory analysts provide a centralized service, streamlining the collection of essential regulatory documents (including but not limited to: informed consent, protocol, Investigator Brochure, draft budget, FDA/IND acknowledgement letter, 1572, financial disclosure forms) and signatures required to expedite PRMC and IRB submission.
Post-Activation support:
Regulatory analysts prepare the required regulatory documents for all active clinical studies including continuations, closures, terminations and amendments. They liaise with clinical investigators, IRB, and study sponsors, maintain the Clinical Trials Management System to ensure all protocol-related documents are current and that informed consent documents are amended as required.
IT Capabilities
Velos eResearch is a web-based clinical trials management system (CTMS) that effectively houses all clinical trial and patient related information. It is a HIPAA-compliant, comprehensive relational database solution for managing all aspects of clinical research; providing a centralized, password-protected CTMS, easily accessible at all times.
The Sylvester Clinical Trials app for smartphones and tablets pulls clinical trial details directly from Velos and clinicaltrials.gov to provide current Sylvester open interventional clinical trial information. The app features include: protocol listings by Site Disease Group, protocol descriptions, eligibility requirements for each protocol, searching, favorites, contact information, email protocol details, and links to other cancer resources.
Leadership
Jose Lutzky, M.D.
Medical Director