Clinical Trials and Regulatory Writing Primer

This course introduces the components of effective clinical trial design, and the basic phases, and purposes of pharmacological and clinical development.  Gain foundational knowledge of the overall clinical development process and understand and adequately use clinical trial terminology that is used in regulatory writing.  Topics include trial designs by stage, types of trial designs, ethical considerations, study procedures, endpoints, data analyses and statistical considerations. 

There are no prerequisites for this course and it is open to those seeking a individualized learning expereince. Serves as a required course for students pursuing the Medical Writing Regulatory Capstone Track.  Equivalent coursework or knowledge must be demonstrated if the student does not have pharmaceutical industry background.  By the end of this course, you will be able to:

Identify the basic terminology related to clinical trials and the pharmaceutical industry
Discuss the clinical research process and clinical trial designs 
Build foundational skills for advanced regulatory writing projects