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Clinical Documentation

Course Description

This course will focus on the laws and regulations, documentations and process imposed by the Federal government especially the Food and Drug Administration related to pharmaceutical and medical device approval and the clinical trials associated with the approval process. Emphasis is placed on designing and implementing appropriate clinical trial protocol documents as well as all forms associated with the clinical trials used for evidence based documentation of the trial(s). Statistical justification will also be introduced for use as to methodology and analysis of the trial.

Learning Outcomes

  • Develop and implement appropriate protocol documents for initiation of a clinical trial.
  • Develop study forms and clinical report forms for evidence based documentation of the clinical trial.
  • Develop a standard operating procedure for all phases of a clinical trial.
  • Develop a quality assurance (Q/A) and quality control (Q/C) documents.
  • Apply statistical methods for justification for the trial methodology.
  • Design and implement ‘ad hoc’ documents to fulfill FDA requirements for product approval from the clinical trial.

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.

Four-Week Classes

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.

Year-Round Enrollment

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.

Military Friendly

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
Sarah H. and Caryl F.
Class of 2019, Military Servicemember and Class of 2019, respectively