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.
- 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.
Recommended: Prior completion of
Why Choose National University?
We’re proud to be a veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 185,000 alumni worldwide.
Focus on one subject at a time — one month at a time — and finish your degree faster.
75+ Degree Programs
Choose from associate, bachelor’s, and master’s degrees, plus credentials and certificates.
On Campus or Online
Study when and where it’s convenient for you with evening, weekend, and 100% online classes.
Apply or transfer any time. Classes start monthly, and applications are accepted year round.
Attend class and learn onsite at one of over 20 locations in California.
As a Yellow Ribbon school, we offer tuition discounts to servicemembers and dependents.