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Apr 19, 2024
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MEDDV 121 - Clinical Data Management I
3.0 Credits
Introduction to organization and management of study data from medical device trials and effective presentation of data in reports. Covers database structures, data management systems, quality assurance, data confidentiality/security, and preparation of case report forms.
Course-level Learning Objectives (CLOs)
Upon successful completion of this course, students will be able to:
- Understand the terms, concepts and planning processes of Data Management.
- Identify all aspects of the data management lifecycle and understand how they interact.
- Identify the roles and responsibilities of the clinical research team.
- Assess data management systems to determine the best possible database system for a specific project and/or program.
- Develop, edit and analyze case report forms (CRFs).
- Describe means of data presentation in listings, tables and graphs.
- Be fluent in clinical trial terminology and regulations as they apply to data management.
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