This course provides the student with a solid foundation and understanding of how clinical data contributes to the market application process. Beginning with describing the documents required for regulatory approval of products for marketing, the course will discuss the planning process for data collection, processing, management, analysis, and summarization. Overall consideration in the generation of databases and analyses of data will be explored. Key statistical principles and tools will be applied to clinical trial protocols and statistical analysis plans.
- Evaluate the key components in data collection, management, and processing.
- Examine the key statistical concepts routinely employed in analyzing, summarizing, and interpreting the data generated in the process of clinical research.
- Distinguish clinical trial monitoring as a process of preserving data integrity.
- Differentiate between clinical trial protocols, case report forms, statistical analysis plans, clinical study reports, overall development databases, and marketing approval applications.
- Defend the process of critically interpreting published medical literature.
- Formulate the development of a sound scientific and statistical approach to creation of a clinical trial.
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 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.