Clinical Protocol and Data Management

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CLINICAL PROTOCOL & DATA MANAGEMENT ABSTRACT The Moores Cancer Center (MCC) Clinical Trials Office (CTO) provides a centralized resource for the conduct of cancer-related clinical research at University of California San Diego (UCSD) including the affiliated Rady Children’s Hospital. The purpose of the CTO is to provide an effective and efficient infrastructure to support MCC investigators in developing, implementing, and reporting on all cancer clinical research studies at MCC. The Moores Cancer Center Clinical Trials Office provides the following services: · Serves as a central clinical research information repository that facilitates Center-wide communications, subject accrual tracking, and monitoring of the progression for all clinical studies from inception to final publication. · Assists MCC investigators in the timely activation and administration of clinical studies, including the preparations and communications required for scientific, ethical, financial, and operational reviews as well as ongoing support for annual regulatory reviews. · Assists clinicians in screening and enrolling patients for clinical research studies. · Coordinates and ensures the completion of patient-specific study requirements. · Provides data management support for clinical research studies. · Prepares medical and research records for internal and external quality and compliance audits. · Provides clinical research training and education to CTO staff and investigators related to best practices in conducting clinical research. · Performs quality assurance activities and monitors compliance with federal requirements such as study registration to clinicaltrials.gov and NCI’s Clinical Trials Reporting Program. · Communicates the availability of clinical studies to MCC physicians, referring physicians, and the public.