Clinical Trials Core

Washington University, Saint Louis MO

Investigators

Linked publications & trials

Abstract

The SCC Clinical Trials Core (CTC) provides critical support to Siteman Cancer Center investigators for cancer clinical research. The goal of the CTC Is to facilitate translational research by providing access to an effective, efficient, and economical clinical research team highly specialized in cancer research. Comprehensive services are available through the CTC for all aspects of protocol development, regulatory submissions, study coordination, data management and education and training, all of which will be essential for the SCC's growth in translational clinical research. ¿ Protocol development staff provide expertise and research assistance in the following areas: study design; protocol and consent form development and editing; facilitating biostatistical support; development of data collection methods; and facilitating development of study-defined database tools. ¿ Regulatory services include management of all regulatory affairs. These services include protocol submission and processing; trial close-out; Protocol Review & Monitoring Committee (PRMC), Quality Assurance & Safety Monitoring Committee (QASMC), and Human Studies Committee (HSC, WU IRB) submissions; assembling IND applications to the FDA ; and interaction with other regulatory agencies and institutional offices [NIH Recombinant DNA Advisory Committee (RAC), Institutional Biosafety Committee (IBC)), Radiation Safety Committee (RSC); Radioactive Drug Research Committee (RDRC), Centerfor Clinical Studies (CCS), Office of Technology Management (OTM)] ¿ Studv coordination includes services in all aspects of trial conduct and data management, including but not limited to: trial logistics assessment; eligibility verification; study coordination; data collection; record retention; data safety and monitoring reporting; audit and monitoring preparation; adverse event assessment and reporting; and data summary completion for analysis. ¿ Education and Training of the Clinical Trials staff is provided by an aggressive orientation, training, and tracking program. Additionally, the program provides continuing education opportunities to the staff. This service is currently available to the CTC staff on an ongoing basis. The CTC also assists investigators with identifying potential funding sources, budget and contract development and other study-related activities, and provides clinical trials tools (e.g., SCC protocol Index, Web postings and electronic access to protocol documents).