St. Jude Children's Research Hospital (SJCRH) is a freestanding research institution and an NCI-funded Cancer Center. The clinical research program completes more than 2,000 new protocol enrollments per year and has registered 759 new patients in the past 12 months. There are currently 82 open therapeutic protocols and 47 nontherapeutic protocols. Before opening to accrual, all protocols are approved by the Institution's Clinical Protocol Scientific Review and Monitoring Committee and Institutional Review Board (IRB). As a part of the approval process, the IRB reviews the study monitoring plans. The responsibility for monitoring rests largely with the Central Protocol and Data Monitoring Office (CPDMO) and the external Data and Safety Monitoring Board. However, because of the growth of the clinical tdals program, in 2001 a Contract Research Organization was engaged to monitor a select group of trials. As the clinical trials infrastructure evolves, the Institution also continues to build a comprehensive education program for investigators. All investigators and key personnel must complete training before participating in research involving human subjects. Partial support is requested in this application for two areas: 1) Trial Monitoring. Funds will be used to offset some of the large CRO costs as we make the transition to full institutional staff monitoring. Funds are also requested to support one additional SJCRH monitor position to enable us to build the CPDMO staff more quickly. 2) Clinical Investigator Training. Funds will be used to enhance our broad program of investigator training. Activities include formal training sessions, invited speakers, and regional conferences. This support will enhance the protection of research subjects by helping to integrate and strengthen the monitoring and training processes at SJCRH. The balance of support for these activities during the funding year will be provided from institutional sources. SJCRH will fully fund these activities by 2004, using a combination of institutional funds, peer-reviewed grants and contracts, and pharmaceutical company support.
