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CLINICAL RESEARCH TRAINING

HUMAN SUBJECTS PROTECTION COURSE

COURSE DESCRIPTION:

 
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.

COURSES

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

Training Solutions For These Roles

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.

TYPE

Online – Train on Your Own Time


CEUs

1 hour (.1 CEUs)

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