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 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]