CORE--CLINICAL TRIALS RESEARCH OFFICE

University Of Wisconsin Madison, Madison WI

Investigators

Linked publications & trials

Abstract

The Clinical Trials Research Office (CTRO) serves as the coordinating center of the UWCCC clinical research enterprise. As such as it is organized into two complementary units, Clinical and Data, mirroring the organization of a typical national cooperative oncology group with member institutions and data management center. The CTRO provides the infrastructure for oversight, coordination, management, and monitoring of support services to facilitate UWCCC clinical research activities of the highest quality. Centralization of these activities ensures standardization in the conduct of clinical research studies across all the UWCCC clinical research programs and gains efficiency and economies of sale in providing support services. Basic services include both regulatory and Human Subjects Committee coordination and oversight; protocol implementation, activation, and closure; patient registration and randomization; protocol and patient tracking; quality assurance; and development of uniform policies and procedures. Additional and expanded services, funded by individual projects, are available to UWCCC investigators without their own clinical research support staff. These services funded protocol development, data monitoring, review and analysis, study management, data collection and program management. Services provided by the CTRO support all levels of clinical research studies from phase I through III, sponsored by a variety of funding sources; UWCCC investigator- initiated clinical trials represent a large portion of the UWCCC clinical research portfolio. The CTRO played a critical role in the inception and development of the UWCCC Protocol Database for protocol tracking and patient registration during the last grant cycle and will continue to play a major role in the implementation of a new UWCCC Clinical Research Database system for protocol-specific data collection and management in the next grant cycle. The current UWCCC Protocol Database system is indispensable in supporting the Protocol Review and Monitoring System, and the proposed UWCCC Clinical Research Database system will be critical for the integrity of all UWCCC clinical research studies.