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NT23: Introduction to Clinical Research Monitoring	Back to Homepage

	Lessons

•	Module Training PowerPoint_2006

•	Introduction to Monitoring Clinical Trials

•	FDA Drug History

•	Belmont Report

•	Declaration of Helsinki

•	21 CFR and ICH Monitoring Requirements

•	Intro to Clinical Research Quiz

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FDA-1572

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Lesson 9

Reference Material

FAQs	Glossary
Digital Library

Communication

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'Introduction to Clinical Research Monitoring'

This course explains the purpose of monitoring clinical trials. Current monitors or those new to the profession will learn about the role of the monitor as designed in the regulations. Students will also be introduced to the history of clinical investigations. A strong foundation in drug development will also be discussed. This course has a regulatory and legal presentation of the requirements for monitoring and the need for close oversight by the monitor including lessons on:

Conducting Clinical Investigations
Risks and Benefits of Drug Products
U.S. FDA Drug History
U.S. Drug Development
Marketing a New Drug
Role of the Monitor
Monitoring Clinical Trials
21 CFR and ICH GCP Monitoring
Delegation of Authority Concepts

2 1/2 hours of Education for the Clinical Research Monitor/CRA.
2.5 Contact Hours or 0.3 CEUs
$75.00

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	You need to complete all the lessons in order to receive a completion certificate. You also need to complete other required activities: •Activity List This course must be completed within 90 days of enrollment, unless purchased as part of a complete Training Program such as NT20 or NT50.


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