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Principal Investigator Role-Based Package

For: New and experienced Investigators who need training on their research responsibilities. The Foundation Package is included to provide a solid knowledge base for conducting clinical research with human subjects.

Learners will be able to describe the responsibilities of a principal investigator, understand the requirements they must follow when conducting a clinical study, understand how responsibilities may be delegated to other study personnel with proper oversight, and recall common warning letter findings. The Foundation Package includes two introductory courses on the FDA regulations, a good clinical practice course with an overview of the history of clinical research, a course in human subjects protection, and our signature FAIR Shake(TM) technique, which teaches the learner to take an otherwise complicated maze of requirements and break them down into four simple areas that can be applied to solving clinical research questions.  Understand how to protect research subjects and how and when to report adverse events. 

The approximate time to complete each course and quiz is noted next to each course topic.

Upon successful completion of this course package, learners will receive 8 continuing education contact hours.


a.    Principal Investigator Overview - (50 minutes)

b.    Foundation Package                            
    i.    An Introduction to the U.S. FDA Regulations
        1.     Part I: 21 CFR Part 312 and 812 - (55 minutes)
        2.     Part II: 21 CFR Parts 50, 56, 54, and 11 - (40 minutes)
        3.     Comparing 21 CFR Parts 312 and 812 - (55 minutes)
    ii.    Good Clinical Practice
        1.     The History of Clinical Research - (60 minutes)
        2.     Introduction to Good Clinical Practice - (40 minutes)
        3.     The FAIR Shake(TM) Method  - (35 minutes)
    iii.    Human Subjects Protection
        1.     Human Subjects Protection: Drilling Down 21 CFR Part 50 - (40 minutes)
        2.     Introduction to HIPAA/HITECH - (40 minutes)

c.    Adverse Event Classification and Reporting - (45 minutes)