This proposal responds to the need for Biostatistics and Data Management Center (BDMC) as described in RFA 97-020, """"""""Co-operative Trials in Diagnostic Imaging"""""""". Pursuant to the RFA, this proposal is submitted in co-ordination with a proposal for Headquarters of the """"""""American college of Radiology Oncologic Imaging network"""""""" (ACROIN). Should the grant be awarded, the proposed BDMC of ACROIN will be organized and operated jointly by the Center for Statistical Sciences, Brown University and the American college of Radiology. Data collection and management will be carried out at the Philadelphia facilities of the ACR. Study design, monitoring and data analysis will be preformed at brown. Key aspectes of the operation of BDMC will be the folloowing: (1) To provide support and methodological leadership to ACROIN investigators in the design, development and implementation of network studies. (2) To work with ACROOIN investiggators in the desgin, development and implementation of data collection forms and procedures and to carry out appropriate pilot testing of protocol implementation and data collection procedures. (3) To cary out the data collection in each ACROIN protocol and develop and maintain a primary study database at the Data Management Center in Philadelphia. To imlement an efficient and accurate mechanism for on-line access to the study database by the Biostatistics Center personnell for purposes of study, monotoring, and analysis. (4) to monitor and verify the quality of the data, including checks of accuracy, completness and timeliness. (5) To monitor and verify compliance to all aspects of the propocol and to desgin and implement rigourous quality control for imaging and other studies; to develop and implement a process for performing site audits and to generate timely audit reports. (6) To design and perform intermin and final analyses of the data, geerate relevant reports and co-author abstracts and manuscripts. (7) To address methodolocial issues arising in the design and analysis of ACROIN studies and to carry out research on statistical methodology for the evaluation of imaging in cancer diagnosis and management
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