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CLINICAL RESEARCH TRAINING

FOUNDATION PACKAGE

COURSE DESCRIPTION:

Provide a solid knowledge base for conducting clinical research with human subjects.  Includes two introductory courses on the FDA regulations. One session covers 21 CFR Parts 312 and 812, and the other covers 21 CFR Parts 50, 56, 54, and 11.  It also includes a course comparing 21 CFR Parts 312 and 812.
 
Additionally, the Foundation Package includes good clinical practice with an overview of the history of clinical research. The Human Subjects Protection course reviews 21 CFR Part 50 in more detail as well as HIPAA in research. The Package also includes a course on 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.
 
The approximate time to complete each course and quiz is noted next to each course topic.
 

COURSES

An Introduction to the U.S. FDA Regulations
  • Part I: 21 CFR Part 312 and 812  - (55 minutes)
  • Part II: 21 CFR Parts 50, 56, 54, and 11  - (40 minutes)
  • Comparing 21 CFR Parts 312 and 812  - (55 minutes)
 
Good Clinical Practice
  • The History of Clinical Research - (60 minutes)
  • Introduction to Good Clinical Practice - (40 minutes)
  • The FAIR Shake Method (35 minutes)

Human Subjects Protection

  • Human Subject Protection: Drilling Down 21 CFR Part 50 (40 minutes)
  • Introduction to HIPAA/HITECH (40 minutes) 

Training Solutions For These Roles

Sponsor organizations and their project managers, sales professionals, research coordinators, monitors and anyone else involved in the clinical research process

TYPE

Online – Train on Your Own Time


CEUs

4.75 hours (.475 CEUs)

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