GYNECOLOGIC ONCOLOGY GROUP

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This proposal is for continuation of funding required to staff and operate the Statistical Office of the Gynecologic Oncology Group (GOG), a cooperative research group. It is the function of this office to collect, abstract, code, update, process, analyze and present the data submitted by member institutions. Additionally, the GOG Statistical Office plays a major role in the design, formatting and randomization of all new protocols, implements interim and final study chairman's reviews, and is the focal point for the preparation of all GOG abstracts and manuscripts for publication. A primary objective of the GOG Statistical Office during the upcoming grant period is the smooth integration of randomization, forms tracking, delinquency monitoring, and modality quality control into the GOG Statistical Office mechanism. These tasks were previously accomplished by GOG Operations Office but have been reassigned to the Statistical Office following the last site visit and corresponding critique. Our principal objective is to manage patient data in an efficient and accurate manner, resulting in timely analyses, logical and appropriate interpretation of results and relevant publications. the achievement of these goals will have direct bearing upon the future management of patients with gynecologic malignancies. The methodology involved consists of: (a) Involvement of GOG Statistical Office in all phases of study design, conduct, management and interpretation as mandated by GOG Protocol Procedures Manual; (b) Incorporation of randomization and quality control procedures into the GOG Statistical Office operation; (c) Expansion of Roswell Park Management Information Systems (RPMIS), using main-frame version of SIR to implement forms tracking and quality control; (d) Continued expanded use of computer evaluation sheets (EVL's) which facilitates interaction among study chairman, data abstractor, and statistician; thus, each protocol is thoroughly reviewed twice-yearly in order to resolve questions and incorporate comments or suggestions into the patient data. (e) Coordination, monitoring and preparation of all GOG publications.