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Human Subjects Protection
This course examines human subjects protection in more detail, with an in-depth look at 21 CFR Part 50 as well as an introduction to the HIPAA and HITECH regulations. Learners will gain a thorough understanding of the important role of informed consent and privacy protections in clinical research.

Objectives:
Learners will be able to describe the steps required for obtaining proper informed consent according to the regulations, list the requirements for documentation of the informed consent process, and recall the basic and additional elements of informed consent.

Learners will be able to describe HIPAA and HITECH legislative acts, list individually identifiable data elements that are protected under HIPAA and HITECH, and explain the impact that HIPAA and HITECH have on clinical research.

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

Upon successful completion of this course, learners will be eligible to receive 1 continuing education contact hour.


Sessions Included:
    1.     Human Subjects Protection: Drilling Down 21 CFR Part 50 - (40 minutes)
    2.     Introduction to HIPAA and HITECH - (40 minutes)

$50.00
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