CORE--CLINICAL RESEARCH MANAGEMENT

Oregon Health And Science University, Portland OR

Investigators

Linked publications, trials & patents

Abstract

Description: (Applicant's Description) The Clinical Research Management (CRM) Shared Resource provides oversight and training services for CRM personnel, maintains all protocols in a central location, advises investigators on eligibility for centralized patient registration, disseminates appropriate information for protocol development, supports centralized data management (except for data entry for individual projects) and provides quality assurance oversight of Clinical Research Specialists and Data Managers involved in the conduct of clinical trials supported by the Oregon Cancer Center. Two related components, described in subsequent sections, detail this overall activity: Protocol Specific Research Support and the Clinical Trial Scientific Review and Monitoring System. Protocol Specific Research Support is used to support innovative and translational investigator initiated Pilot/Phase I and small Phase II institutional protocols which have been reviewed and approved by the Clinical Research Review Committee (CRRC) with high priority. The Protocol Review and Monitoring System, Section 9.9 of the CCSG, is the mechanism by which proposed projects are reviewed and ongoing Cancer Center supported clinical research projects are monitored. The impetus for providing centralized services through the CRM is to ensure high quality data management and conduct for clinical research, cost effectiveness, elimination of duplicative efforts, and to provide a mechanism for fostering collaboration among investigators interested in addressing the cancer problem through innovative institutional clinical trials.