The Data Management and Statistical Core will be responsible for receiving, editing, quality monitoring, storing, and analyzing all data generated during the course of the proposed clinical trial. The DCC will be responsible for creating and maintaining all databases and data entry systems. General functions are: 1. Working with the principal clinical core physician investigators, to develop the Operations Manual and all Case Report Form (CRF) Instruments; 2. Developing a system of random assignment to the treatment groups for each patient eligible and willing to participant in the trial, and making the necessary arrangements for carrying out the random assignment at the Clinical Centers; 3. Accumulating and maintaining appropriate data files while ensuring confidentiality and security of these data files (including cleaning and editing, all data); 4. Developing appropriate methods of analysis and presentation of data collected during, the course of the study for the clinical and the laboratory studies; 5. Preparing semi-annual scientific reports describing the progress of the project during the previous six months, as well as the cumulative proloress. of the study. These reports will describe the monthly accrual history of each clinical center, interim analysis, clinical and pathology data, adverse effects, and results of quality control measures; 6. Preparing reports of the study for publication in collaboration with the Clinical Core physician investigators; 7. Participating in the training of data collection personnel at each participating clinical center; 8. Providing long-term storage of the study forms and other documents; 9. Operating the computer facilities: The computer hardware facilities used for this project range from a central main frame IBM ES/9000 to a microcomputer network. The local server supports PCs, scanners, and HP laser pninters. Microsoft Access will also be used for data management and for registration, randomization, and forms collection. For data analysis, SAS and S-Plus will be used. 10. Ensuring that all activities conform to federal regulations regarding protection of human subjects.
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