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.