) This application responds to the need for a Data and Statistics Center operations for the Multi-Institutional Consortium for Clinical Evaluation of Magnetic Resonance Imaging in Breast Cancer, announced in RFA CA96-012. The proposed center will be based at the Center for Statistical Sciences, Brown University in Philadelphia, PA. Data collection and management will be carried out by the DMC of ACR. Data will be transferred at regular intervals to the Statistics Center at Brown where study monitoring and interim and final analyses will be performed. The key aspects of the operation of the Data and Statistics Center are described in the following specific aims: 1) To provide support and methodological leadership to Consortium investigators in the design, development and implementation of the new protocol; 2) To work with Consortium investigators in the design, development and implementation of data collection forms and procedures. To carry out appropriate pilot testing of protocol implementation and data collection procedures; 3) To carry out the data collection and to develop and maintain a primary study database at the Data Center. To implement an efficient and accurate mechanism for data transfer to the Statistics Center and to develop a database at the Statistics Center for purposes of study monitoring and data analysis; 4) To continually monitor and verify the quality of imaging studies and the compliance to the common protocol. To develop and implement a process for performing site audits and to generate timely audit reports; 5) To continually monitor and verify the quality of the data, including checks of accuracy, completeness and timeliness; 6) To address methodological issues arising in the design and analysis of this multi-center study; 7) To design and perform interim and final analyses of the data and to generate relevant reports; 8) To provide methodological leadership and support in summarizing and interpreting study findings and in the preparation of abstracts and manuscripts. This application for a Data and Statistics Center was planned and submitted in coordination with the application for Headquarters submitted by Dr. Mitchell Schnall, from the University of Pennsylvania.
