During the past 3 years, our Core has established a successful operation of data management, experimental methodology consultation, biostatistics, review of proposals, contribution to papers, training, and related functions. The specific data management service aims are: 1.) To design, develop and maintain research quality, highly reliable CRC data hardware and software systems at both the physical and logical levels; 2.) To facilitate access by CRC investigators to shared CRC data on a scheduled basis and to provide flexible sets of aggregate information on subjects and variables of interest. Also to supply timely clinical management reports including patient participation and missing data control information; 3.) To develop and maintain specific procedures and policies to ensure quality of the data; and 4.) To develop and maintain specific procedures and policies to ensure confidentiality of data. The hypothesis testing functions are: 1.) To consult with other CRC Core investigators on specification of research and statistical hypotheses, study design, and statistical plans for CRC Core, Project and R01 research hypotheses and to contribute to proposals before they are finalized, and review all CRC and R01 protocols for appropriateness of design, statistical plans and sample size; and 2.) To consult with CRC investigators on performance of statistical analysis and on interpretation and presentation of results; and to perform statistical analysis or mathematical or statistical modeling of CRC data to test CRC hypotheses, especially when the analysis is complex or when the data are from several different Cores, to provide interpretation of results, and to contribute to manuscripts; and to review CRC generated draft papers for appropriateness of analysis and interpretation and presentation of results. The hypothesis generating functions are: 1.) To consult with other CRC investigators on performance of or to perform exploratory analyses with the goals of generating hypotheses for subsequent test and confirmation and generating estimates of effect size for use in power analyses, to perform the power analyses, and to contribute to proposals aimed at confirming these hypotheses; and 2.) To collaborate on performance of exploratory analysis using data from published literature with the same goals of generating hypotheses and preliminary estimates of effect size. The biostatistical and data management training functions are: 1.) To provide appropriate statistics education to all CRC investigators, trainees and staff, including consultation on establishing and maintaining reliability of assessment instruments and procedures; and 2.) To provide training on data management considerations and designs.
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