Core--Clinical trials office

Vanderbilt University, Nashville TN

Investigators

Linked publications, trials & patents

Abstract

The primary mission of the Clinical Trials Shared Resource (CTSR) is to assist Cancer Center investigators develop, activate and complete scientifically valid clinical trials in an organized, cost-effective and methodologically sound manner. To enhance the efficiency of clinical trials support staff, all institutional data managers, research nurses and clerical staff engaged in cancer clinical trials activity have been consolidated into a shared resource under the direction of Dr. Barbara Murphy and Ms. Debbie Wujcik, R.N., M.S.N.. This consolidation permits pooling of support dollars as well allowing for maximum utilization of such funding. The CTSR is designed to facilitate investigator- initiated research. The major areas of responsibility of the CTSR include: 1) protocol support services including protocol activation and monitoring, 2) provision of data management services and 3) provision of research nursing support. In order to provide these services in an organized and uniform manner, services have been grouped into three categories: Core Services, Data Management Services, and Research Nursing Services. The CTSR strives to facilitate scientifically sound research programs in specific areas of investigation. This is accomplished through disease-specific and modality-specific research teams which consist of physician investigators, data managers, nurses and associated staff with an interest in specific malignancy or category of malignancies (e.g. thoracic oncology). Research teams are responsible for: 1) protocol review and program development; 2) protocol activation through the IRB and scientific review committees; 3) identification, consent and registration of eligible patients; 4) data acquisition, data management and quality control; and 5) provision of protocol information to participating VCC investigators. With the assistance of CTSR staff, physician team leaders convene regular meetings during which there is review of protocol accrual information, data management activities and workload and adverse events. In addition, the teams review and evaluate new protocols, set program and study priorities, and make decisions regarding resource allocation.