The research proposal requests funding to enable us to continue as the Statistical and Data Management Center for the National Surgical Adjuvant Breast and Bowel Project (NSABP). Our objectives include: 1. To provide data management support for the collection, editing, and entry of data from trials being conducted by the NSABP. 2. To work with the members and colleagues in the operations center to design, implement, manage, and analyze new and current clinical trials which address therapeutic questions. 3. To work with clinical colleagues in the design and analysis of trials which address questions regarding scientific issues adjunctive to the primary research efforts. 4. To contribute to the statistical literature by developing statistical methods relevant to the design and analysis of clinical trials. 5. 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 (to include toxicity reporting), d) data quality monitoring (to include internal quality control), and e) continuing education. 6. To pilot a computerized system for: a) assisting in patient scheduling, b) standardizing systems across our main members and, ultimately c) beginning direct data entry and verification from our main members. 7. To prepare annual Progress Reports for the membership and study sponsors. 8. To utilize the existing database and collaborate with others who have similar interests in addressing relevant clinical trial issues such as cost-effectiveness of routine testing, prognostic factors for disease recurrence, etc. 9. To support the NSABP Operations Center in the conduct of their activities relative to institutional performance evaluations and reimbursement, maintenance of administrative computer files, and compliance to regulatory requirements.
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