The offeror shall serve as a statistical coordinating center for the pediatric cohort of the Cooperative Study of Sickle Cell Disease (CSSCD). The Statistical Coordinating Center has as its major responsibility participation in the statistical design of the study and the development of operational and analytical methodology. The Center is responsible for data management and analysis, generation and distribution of reports, development of forms design and Manual of Operations, and.assistance with meetings. Under the direction of the Program Office, the statistical coordinating center has the overall responsibility of ensuring that the provisions of the Manual of Operations are carried-out by all investigating groups. Total study enrollment is estimated at 440 children. Contract performance is divided into three stages: I- Protocol/Manual of Operations Development; II. Patient Entry and follow-Up; and III. Data Analysis, Documentation, and Manuscript Preparation.
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