This course is designed to give the student a “hands on” real world experience working in a clinical trial environment. The student will acquire fundamental knowledge in evidence based clinical data, statistical analysis and documentation of clinical results. The student will be required to write a critical evaluation of the clinical trial a complete analysis of methodology, clinical forms, FDA regulations and data management. Grading is by S or U only. Course is eligible for an “IP” grade.
- Understand the implementation of protocol in a clinical trial.
- Evaluate evidence based clinical data.
- Develop a data management system with clinical trial outcomes.
- Understand all documentation used in the clinical trial for FDA approval.
- Design clinical report forms, standard operating procedures, compliance documentation IRB submittals and all other documents necessary for FDA approval.
- Understand the FDA regulations as related to the clinical trial.
- Understand audits and adverse events.
- Be familiar with content and preparation for FDA meetings.
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 175,000 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.
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.