This course is designed to present an introduction to the global regulations governing the conduct of clinical trials and for regulatory approval of a new biologic, medical device, or pharmaceutical product. The student will be introduced to EMA, FDA & ICH regulations and standards, regulatory violations documented in warning letters, clinical roles and responsibilities, as well as the IRB/IEC process, and key study documents and principles of clinical study management.
- Appraise the key elements of GCPs and the equivalent elements contained in the ICH guidelines for the conduct of human clinical trials.
- Contrast the key clinical trial conduct responsibilities that apply to a study sponsor, an IRB, and a study investigator.
- Examine the key steps chronologically for the set up and operation of a clinical trial.
- Select the essential documents required to conduct a clinical trial.
- Evaluate the key sections of a basic study protocol and informed consent form.
- Design a clinical study report summarizing clinical trial results.
- Assemble key FDA nomenclature pertaining to Good Clinical Practice Regulations.
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 150,000 alumni worldwide.
Focus on one subject at a time — one month at a time — and finish your degree faster.
100+ 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.
20+ Campus Locations
Attend class onsite at one of over 20 campus locations across California or in Nevada.
As a Yellow Ribbon school, we offer tuition discounts to servicemembers and dependents.
School of Health and Human Services
“Our faculty members are nationally recognized across a broad spectrum of health profession disciplines and prepare students for success in the ever-evolving health care field.”School of Health and Human Services