In response to RFA NIH-91-HL-03-P entitled """"""""Insulin, Insulin Resistance,Hyperglycemia and Cardiovascular disease,"""""""" we propose a Clinical Coordinating Center (CCC) directed by biostatisticians, epidemiologists and data managers from Bowman Gray School of Medicine. We have assembled a team of highly qualified investigators with expertise in the design and management of epidemiologic and clinical trails, database development, decentralized data management, forms design, and statistical analysis. In this proposal, we describe our plans for ensuring that the goals of this project are met expeditiously and efficiently. The responsibilities of the CCC include providing administrative, scientific, and technical support personnel and facilities required to meet the operational, biostatistical, data management, and computing requirements of the study. To meet these goals the CCC will: (1) assist the NHLBI Project Officer and Executive Committee by arranging for Steering Committee and Quality Control (QC) Meetings, (2) develop, print and distribute the protocol, the Manual of Procedures, the study forms, and the training manuals and materials, (3) coordinate interactions between clinical centers and central facilities including the Central Blood Laboratory, ultrasound center, and ECG/Echocardiogram centers, (4) develop and implement a distributed data management (entry) system, (5) coordinate, train, certify, and recertify clinic staff and data management personnel in the Clinical Centers, (6) establish procedures and monitor the quality of laboratory measurements and Clinical Center operations, and make recommendations for improvement when appropriate, (7) develop a stratified randomization list and procedures for selection of appropriate proportional sampling over a range of glucose metabolism, age, race, and sex, (8) monitor recruitment of study participants, (9) monitor the receipt of data obtained from Clinical Centers laboratories and/or Reading Centers, (10) submit regular and special technical and scientific reports to the NHLBI Project Office, the Steering Committee, the Quality Control Committee and External Advisory Boards, (11) in coordination with the clinical center investigators and with the Project office, we will coordinate and conduct analyses for data presentations and publications, and (12) provide statistical and epidemiological expertise in discussions regarding data analysis plans.
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