9.1.13 CLINICAL RESEARCH SHARED SERVICE The mission of the Clinical Research Shared Service (CRSS) is to integrate and facilitate the management. Coordination and conduct of clinical research at the Arizona Cancer Center (AZCC) and to ensure that the clinical trial processes meets local, state, and federal policies and regulations. The following objecfives are designed to accomplish this mission: (1) Provide centralized administrafion and processing of clinical trial documentafion via the AZCC Clinical Administration Trials Office;(2) Provide centralized Data Management and Research Nursing services with a focus on Therapeufic trials;(3) Provide pharmacy admixture and inventory maintenance for invesfigafional agents used in peer-review clinical trials in the mulfidisciplinary clinics;(4) Aid in the development of novel formulafions or combinafions of agents for invesfigators performing pilot clinical trials;(5) Oversee and ensure quality control in the conduct of AZCC clinical trials;(6) Implement a web-based clinical trials management system (Oncore?) to facilitate peer-reviewed clinical research inifiatives and reporting. Dr. Livingston is the current Director. Ms Ma, the Associate Director of Clinical Trials, assists with day-to-day operafions of the CRSS. All clinical research-related documents flow through the AZCC Clinical Trials Office (CTO) for review, processing for further distribufion and submission, and/or maintenance in study-specific regulatory files. The CTO also coordinates and provides administrafive support for the AZCC Scienfific Review Committee (SRC, Protocol Review and Monitoring System). Clinical research activities are accomplished via disease-specific teams consisfing of clinical investigators, research nurse, clinical research coordinators/data managers along with regulatory assistants (IRB Coordinators) and other administrafive support. The AZCC Data Safety and Monitoring Board (DSMB), chaired by Dr. Dragovich, is responsible for quality assurance/quality control in AZCC clinical trials. AZCC has implemented Oncore? to manage daily clinical research operafions. Usage of the CRSS is mainly by AZCC members (77%) and spans most departments and programs. 61% of AZCC member users are with peer reviewed funding. In the period of July 2007-June 2008, The total accrual of therapeufic trials in the four NCI-defined categories is 284.
To integrate and facilitate the coordinafion and conduct of clinical research (therapeutic, prevenfion, populafion science, and translafional) at the Arizona Cancer Center (AZCC) and to ensure that the clinical trial process meets local, state, and federal policies and regulafions.
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