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Gynecologic Oncology Group (GOG)

Gynecologic Oncology Group (GOG). Sharon Stockman, C-CRC The University of Iowa Hospitals Iowa City, IA Chair, GOG Data Management Subcommittee. Objectives. History of the Gynecologic Oncology Group (GOG) Structure of the GOG GOG Committees GOG Data Management Data Management Education

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Gynecologic Oncology Group (GOG)

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  1. Gynecologic Oncology Group(GOG) Sharon Stockman, C-CRC The University of Iowa Hospitals Iowa City, IA Chair, GOG Data Management Subcommittee

  2. Objectives • History of the Gynecologic Oncology Group (GOG) • Structure of the GOG • GOG Committees • GOG Data Management • Data Management Education • GOG / ACRIN Collaboration

  3. History • Founded February 20, 1970 • Clinical research to benefit gynecologic cancer patients • Recognized need for cooperative group approach

  4. Multidisciplinary Organization • Gynecologic Oncologists Social Scientists • Medical Oncologists Basic Scientists • Radiation Oncologists Ethicists • Immunologists Nurses • Pathologists Data Managers • Statisticians

  5. Purpose • Improve the treatment for women with gynecologic cancer • Achieve goals through research encompassing multiple modalities

  6. National Headquarters • Administrative Office • Philadelphia, PA • Statistical & Data Center • Buffalo, NY • Finance Office • Crofton, MD

  7. Membership Structure • Full Member • Provisional Member • Probationary Member • Affiliate Member • Community Clinical Oncology Program (CCOP)

  8. Membership Standards • Patient Accrual • Eligibility and Evaluability • Data Completion • Audit

  9. Clinical Trials • Phase I, II, III • Treatment Trials • Quality of Life • Translational Research • Prevention and Control Trials

  10. Committee Structure • Administrative Committees • Scientific Committees

  11. Administrative Committees • Executive Board • Data & Safety Monitoring • Membership

  12. Scientific Committees • Protocol Development • Operations Committee • Site Committees • Ovary, Corpus, Cervix • Modality Committees • Gynecologic Oncology, Medical Oncology, Radiation Oncology, Pathology, Nursing • Special Studies Committees • QOL, Developmental Therapeutics, Cancer Prevention & Control, Experimental Medicine

  13. Data Management Organization • Data Management Subcommittee • 1 representative from each full member institution • Data Management Steering Committee • Appointed positions • Roles and Responsibilities • Data Management Working Groups

  14. Data Management Roles • DM1 (Full Member Institution) • DM2 (Affiliate Institution) • DM3 • Nurse/Data Manager • Regulatory

  15. Data Management “Electronic and Paper” Resources • GOG Website • GOG Manuals • Newsletters • Statistical Reports

  16. Data Management“Human” Resources • Administrative Office Staff • Regulatory • SAE Reporting • Statistical & Data Center Staff • Data Entry • IT User Support • Data Management Steering Committee • Parent Institution Data Managers

  17. Data Management Educational Programs • Semi-Annual Meetings • New Member Orientation • Business Meeting • Continuing Education • Joint Nursing/Data Management Meeting • Translational Research Training • Annual New Member Training Session

  18. Data Management Educational Needs • New member education • Mid-level to advanced education • Mentoring • User-friendly manual • Website resources/training tools

  19. GOG / ACRINWhat Do We Have in Common? • RECIST • Should we resist RECIST? • Clinical Trials Collaboration • ACRIN 6651/GOG#183 - Results published • ACRIN 6671/GOG#233 - Currently open

  20. GOG / ACRIN“Ultimate Commonality” • GOG – Mission Statement “ ..promoting excellence in the quality and integrity of …research in the field of Gynecologic malignancies. …in order to constantlyimprove the quality of patient care.” • ACRIN – “ACRIN’s goal is – through clinical trials …… – to generate information that willlengthen and improve the quality of the lives of cancer patients.”

  21. Why are YOU here ???

  22. Why amIhere ???

  23. Why are WEhere ???

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