MRA 601 Clinical Documentation

Lead Faculty: Dr. Patric M. Schiltz

Course Description

This course will focus on the laws and regualtions, documentations, and process imposed by the Federal government, especially the Food and Drug Administration, related to pharmaceutical and medical device approval and the clinical trials associated with the approval process.  Emphasis is placed on designing and implementing appropriate clinical trial protocol documents as well as all forms associated with the clinical trials used for evidence based documentation of the trial(s).  Statistical justification will also be introduced for use as to mehtodology and analysis of the trial.

Course Information

• Syllabus
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