Gynecologic Oncology Group

Gynecologic Oncology Group(GOG)

Sharon Stockman, C-CRCThe 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 Oncologists Social Scientists

Medical Oncologists Basic Scientists Radiation Oncologists Ethicists Immunologists Nurses Pathologists Data 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 / 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

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 ???