CORE--CLINICAL TRIALS SUPPORT RESOURCE

University Of Texas Md Anderson Can Ctr, Houston TX

Investigators

Linked publications, trials & patents

Abstract

The mission of the Clinical Trials Support Resource is to serve the patients, faculty, and staff of the University of Texas M.D. Anderson Cancer Center by facilitating the approval and performance of clinical research of the highest quality in an ethical and cost-effective fashion. The Clinical Trials Support Resource is supported by the Office of Protocol Research (OPR) staff and is directed by the Associate Vice President for Clinical and Translational Research and an Administrative Director and is divided into four specialized areas: Protocol Approval and Regulatory Affairs, Office of Clinical Research Quality Assurance, Protocol Data Management System, and Research Finance. The Protocol Approval and Regulatory Affairs area supports the protocol approval process for the clinical Research Committee; the Psychosocial, Behavioral, and Health Services Research Committee; and the Surveillance Committee (Institutional Review Board) to ensure that scientific and patient protection issues are adequately addressed and that the protocols are approved at the institutional level before they are submitted to the NCI for approval. The Office of Clinical Research Quality Assurance monitors the quality of research data, serves as resource in improving data management, and provides an institutional mechanism for managing issues related to research deficiencies or problems. This office works closely with the Protocol Approval and Regulatory Affairs staff to ensure that the NCI stipulations are being met and that the requirement for the PRMS designation in protocol accrual is monitored is fulfilled. The Protocol Data Management System staff supports a comprehensive database developed for clinical research personnel at M.D. Anderson Cancer Center. It provides on-line patient registration for all clinical research protocols and is primarily responsible for tracking submission, patient accrual, adverse events, annual reviews, activations, and terminations for all clinical research protocols. It too plays a critical role in the PMRS process. The Research Finance staff is responsible for overseeing the protocol activity in the Clinical Research Unit and utilizing a cost model to prospectively project the cost and charge of protocols. Although each area is involved with special projects, the primary focus of the Clinical Trials Support Resource is to ensure that the principal investigators are in compliance with federal and institutional regulations, to maintain protocol-related information for the institution, to provide protocol management services to investigators, and to refine the financial system surrounding clinical research.