Request Information

Please complete the form below, and an admissions advisor will contact you shortly.


Apply Now

Ready to take the next step?

The application process is easy. We accept and review applications year-round, and qualified applicants can begin classes any month of the year, depending on your program and location.

Click Apply Now to get started on the next exciting chapter of your life!

Apply Now

CAF645 CAF Communications

Lead Faculty: Irvin Kluth

Course Description

This course will provide the student with the necessary background for preparing verbal and written communications for the clinical affairs function within a biomedical organization. Beginning with an understanding of the documents required for regulatory approval of products for marketing, the course will identify and discuss the planning process for data collection, processing, management, analysis, and summarization. Overall considerations in generation of clinical trial protocols, regulatory communications, and final clinical reports will be covered.

Learning Outcomes

  • Evaluate the key stakeholders in the biomedical organization and clinical affairs function in particular.
  • Contrast the key communication concepts, links, and methods routinely employed in clinical research.
  • Select the key communication instruments and tools of clinical affairs.
  • Design clinical trial plans and protocols, case report forms, clinical study reports, and the respective clinical research approval documents.
  • Defend the value of critically communicating clinical research information.
  • Formulate a sound scientific and strategic approach to communicating clinical results.