l. To provide data management support for the collection, editing, and entry of data from trials conducted by the NSABP; 2. To conduct a quality assurance program that encompasses the five major areas of: a) institutional performance monitoring (to include site visit audits), b) patient safety and treatment monitoring (to include medical review), c) cooperative group regulatory compliance monitoring (to include toxicity reporting), d) data quality monitoring (to include internal quality control), and e) continuing education; 3. To collaborate with the membership and colleagues in the Operations Center to design, implement, manage, and analyze clinical trials which address important therapeutic questions in breast and colorectal cancer; 4. To work with clinical colleagues in the design and analysis of ancillary studies addressing scientific issues adjunctive to the primary research efforts; 5. To communicate the results of our clinical trials through the publication of manuscripts and presentations; and 6. To develop, implement and publish innovative statistical methods in clinical trials design and analysis. In the proposed project period, we will introduce new initiatives to exploit the NSABP historical database, better utilize our Web site and Web-based technologies, evaluate and improve our quality assurance procedures, particularly in the area of medical review, and address NCI initiatives and reporting requirements. Concurrently, we will continue to improve the quality of our data and assure that scientific standards are maintained in the development and analysis of future studies.
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