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Research Coordinator Role-Based Package

For: New research coordinators and those who need to review the fundamentals of clinical research regulations

Objectives:
Introduce new or aspiring research coordinators to their roles and responsibilities within a clinical trial and provide a thorough understanding of the regulations they rely on to perform their duties. 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 5.75 continuing education contact hours.

Courses:

a.    Research Coordinator Overview

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)

$250.00
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