This proposal responds to RFA-CA-07-505 """"""""The American College of Radiology Imaging Network"""""""" and addresses the needs of ACRIN's Biostatistics and Data Management Center (BDMC). This proposal is submitted in coordination 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 and 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 methodologic leadership to ACRIN investigators in the design, development and implementation of network studies. ? 2. To work with protocol teams on the design and implementation of data collection forms and procedures. ? 3. To carry out protocol data collection and to develop and maintain a primary database at the Data ? Management Center and to ensure efficient and accurate access to the database by Biostatistics Center personnel for 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 designed to guarantee the integrity of the database. ? 5. To continually monitor and verify protocol compliance and to support participating sites in achieving high standards of performance. To provide methodologic expertise for site audits. ? 6. To design and perform interim and final analyses and to generate relevant reports. To provide ? methodologic leadership and support in summarizing study findings and preparing manuscripts. ? 7. To address methodologic issues arising in the design and analysis of ACRIN studies and to carry out ? research on statistical methods for the evaluation of diagnostic imaging. ? 8. To work with investigators and research entities requesting access to ACRIN data and to facilitate the maximum, proper use of scientific information from ACRIN studies. To collaborate in the development of common data elements for imaging clinical studies. ? 9. To operate and further develop a reliable, nimble, and effective organization, with clearly defined roles and objectives, a well articulated set of Standard Operating Procedures and federal regulation compliance concerning data confidentiality and human subject protection. ? 10. To organize, facilitate and support outcomes and economics research in ACRIN studies. ? ? ?
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