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Apr 27, 2024
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MEDDV 121 - Clinical Data Management I
Maximum of 3.0 possible Credits
Intro 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 Objectives
Upon successful completion of the course, students will be able to:
- Understand the terms, concepts and planning processes of Data Management. [REASON]
- Identify all aspects of the data management lifecycle and understand how they interact. [REASON]
- Identify the roles and responsibilities of the clinical research team. [REASON]
- Assess data management systems to determine the best possible database system for a specific project and/or program. [REASON]
- Develop, edit and analyze case report forms (CRFs). [REASON]
- Describe means of data presentation in listings, tables and graphs. [REASON]
- Be fluent in clinical trial terminology and regulations as they apply to data management. [ACT]
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