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

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Presentation transcript:

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

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

Gynecologic Oncology Group History Founded February 20, 1970 Clinical research to benefit gynecologic cancer patients Recognized need for cooperative group approach

Gynecologic Oncology Group Multidisciplinary Organization Gynecologic OncologistsSocial Scientists Medical OncologistsBasic Scientists Radiation OncologistsEthicists ImmunologistsNurses PathologistsData Managers Statisticians

Gynecologic Oncology Group Purpose Improve the treatment for women with gynecologic cancer Achieve goals through research encompassing multiple modalities

Gynecologic Oncology Group National Headquarters Administrative Office Philadelphia, PA Statistical & Data Center Buffalo, NY Finance Office Crofton, MD

Gynecologic Oncology Group Membership Structure Full Member Provisional Member Probationary Member Affiliate Member Community Clinical Oncology Program (CCOP)

Gynecologic Oncology Group Membership Standards Patient Accrual Eligibility and Evaluability Data Completion Audit

Gynecologic Oncology Group Clinical Trials Phase I, II, III Treatment Trials Quality of Life Translational Research Prevention and Control Trials

Gynecologic Oncology Group Committee Structure Administrative Committees Scientific Committees

Gynecologic Oncology Group Administrative Committees Executive Board Data & Safety Monitoring Membership

Gynecologic Oncology Group 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

Gynecologic Oncology Group 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

Gynecologic Oncology Group Data Management Roles DM1 (Full Member Institution) DM2 (Affiliate Institution) DM3 Nurse/Data Manager Regulatory

Gynecologic Oncology Group Data Management “Electronic and Paper” Resources GOG Website GOG Manuals Newsletters Statistical Reports

Gynecologic Oncology Group 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

Gynecologic Oncology Group 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

Gynecologic Oncology Group Data Management Educational Needs New member education Mid-level to advanced education Mentoring User-friendly manual Website resources/training tools

Gynecologic Oncology Group GOG / ACRIN What 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

Gynecologic Oncology Group 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 constantly improve the quality of patient care.” ACRIN – “ACRIN’s goal is – through clinical trials …… – to generate information that will lengthen and improve the quality of the lives of cancer patients.”

Gynecologic Oncology Group Why are YOU here ???

Gynecologic Oncology Group Why am I here ???

Gynecologic Oncology Group Why are WE here ???