This proposal responds to RFA CA-03-502I """"""""Letter to American College of Radiology Imaging Network: Cooperative trials in diagnostic imaging"""""""" and addresses the needs of ACRIN's Biostatistics and Data Management Center (BDMC). This proposal is submitted in co-ordination with a proposal from the Headquarters of ACRIN. Should the funding be awarded, the BDMC of ACRIN will continue to be operated jointly by the Center for Statistical Sciences, Brown University and the American College of Radiology. The main responsibility for data collection and management is with the Philadelphia office of the ACR. The overall direction of the BDMC, as well as the main responsibility for study design, monitoring, and data analysis is with Brown. Key aspects of the BDMC operation will be the following: 1. To provide support and methodological leadership to ACRIN investigators in the design, development and implementation of network studies. 2. To work with ACRIN 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 in each ACRIN protocol and to develop and maintain a primary study database at the Data Management Center in Philadelphia. To implement an efficient and accurate mechanism for on-line access to the study database by the Biostatistics Center personnel for purposes of study monitoring and analysis. 4. To continually monitor and verify the quality of the data, including checks of accuracy, completeness, and timeliness. To implement procedures for guaranteeing the integrity of the database. 5. To continually monitor and verify compliance to all aspects of the protocol and to design and implement rigorous quality control for imaging and other studies. To provide methodological expertise for the design and implementation of a process for performing site audits. 6. To design and perform interim and final analyses of the data and to generate relevant reports. To provide methodological leadership and support in summarizing and interpreting study findings and in preparing abstracts and manuscripts. 7. To address methodological issues arising in the design and analysis of ACRIN studies and to carry out research on statistical methodology for the evaluation of imaging in cancer diagnosis and management. ? ? PERFORMANCE SITES: ? Center for Statistical Sciences, Brown University, Providence, RI ? Rhode Island Hospital, Providence, RI ? American College of Radiology, Philadelphia, PA ? ? ?
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