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Course Overview This course is designed to provide a comprehensive understanding of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Data Tabulation Model (SDTM). Participants will gain a solid foundation in SDTM standards, data structures, and their application in clinical data management and analysis. Course Objectives Upon completion of this course, participants will be able to: Understand CDISC SDTM: + Explain the purpose and importance of CDISC standards in clinical research. + Describe the core principles and structure of SDTM. + Identify the key SDTM domains and their relationships. + Apply SDTM Standards: Map clinical data to appropriate SDTM domains and variables. + Create accurate and compliant SDTM datasets. + Validate SDTM datasets for completeness, consistency, and adherence to CDISC standards. + Utilize SDTM in Clinical Data Analysis: Prepare SDTM data for statistical analysis. + Use statistical software to analyze SDTM data. + Interpret analysis results in the context of SDTM. Designed for: + Clinical Data Managers + Clinical Data Analysts + Statisticians + Medical Writers + Regulatory Affairs Professionals
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