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The course reviews the stages in the data management project life cycle from project preparation, through CRF review and database creation to data entry, data quality control and project close out. Compliance with regulatory requirements and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) is emphasized. Students will learn how to establish the necessary infrastructure (the computing environment and its controls), and how to obtain the necessary skills and resources required to manage a successful data management project.
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