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The Imaging and Radiation Oncology Core (IROC) Group: A Proposed New Clinical Trial Quality Assurance Organization

D Followill

D Followill1*, M Knopp2, J Galvin3, T FitzGerald4, J Michalski5, M Rosen6, F Laurie7, E O'Meara8, S King9, (1) UT MD Anderson Cancer Center, Houston, TX, (2) Ohio State University Wexner Medical Center, Columbus, Ohio, (3) Thomas Jefferson Univ Hospital, Philadelphia, PA, (4) University of Massachusetts Medical School, Worcester, Massachusetts, (5) Washington University School of Medicine, Saint Louis, MO, (6) University of Pennsylvania, Philadelphia, Pennsylvania, (7) University of Massachusetts Medical School, Worcester, Massachusetts, (8) American College of Radiology Radiation Therapy Oncology Group, Philadelphia, PA, (9) Milton Hershey Medical Center, Hershey, PA

WE-G-141-1 Wednesday 4:30PM - 6:00PM Room: 141

Purpose: he NCI is implementing the new National Clinical Trial Network (NCTN) Program in 2014 reducing the number of existing study groups from ten to five. The NCTN Program also requires a new combined Imaging and Radiation Oncology Core (IROC) service to provide a uniform QA program.

Methods: The six existing clinical trial QA centers, Radiological Physics Center, Quality Assurance Review Center, RTOG QA Center, Image Guided Therapy Center, ACRIN Core Lab and the CALGB Imaging Core Lab have combined to form IROC. The interdependencies between diagnostic imaging and radiation therapy (RT) will be synergized in IROC eliminating duplication of services within the network and optimizing efficient and effective workflows. A major strength of this new organization will be the development of consistent standard operating procedures for all imaging and RT aspects of the NCTN as well as to facilitate a seamless flow of imaging and RT datasets across the network.

Results: IROC, administered though the American College of Radiology will provide the scientific and technical expertise in both diagnostic imaging and RT to the entire NCTN Program capitalizing on existing infrastructure and expertise at QA centers currently providing services to the NCI Cooperative Groups. IROC's organizational structure will allow the delivery of a broad array of imaging and RT QA services including Site Qualification; Trial Design Support; Credentialing; Data Management and Case Review. IROC will work closely with the leadership of each Network Group and NCI to assure them that imaging and RT data used by the Groups for protocol analysis are accurate.

Conclusion: The proposed IROC Group has hundreds of collective years of experience conducting clinical trial QA and fully understands the QA needs/dataflow requirements of clinical trials to maintain the highest quality clinical trial data that will not obscure the outcomes of clinical trials.

Funding Support, Disclosures, and Conflict of Interest: This work was supported by PHS grants CA10953, CA21661, CA029511 and CA081647 awarded by NCI, DHHS.

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