Temple University 3 credits QARA
Data management is the activity of collecting, reviewing, organizing, and analyzing data from clinical research studies. The data from clinical research studies are the crux of a regulatory submission for a new drug or biologic. There is no basis for a therapeutic claim without data. Thus the success of a submission depends on quality data management practices and strict adherence to regulatory requirements. This course teaches students how to go from collecting data for the first protocol to ultimate submission to a regulatory agency from data collection, management, and reporting perspectives. Note: This course is required for the Certificate in Clinical Trial Management.
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