clinical research training modules-converted
                     Clinical Research Training Modules 
 
CLINICAL RESEARCH CERTIFICATION 
 
ICH GCP TRAINING 
 
The ICH GCP training modules go over the entire ICH GCP guidelines in detail. They teach 
you how to apply them rather than just understand the protocols. This is the essential basis 
of Clinical Research Training. 
 
15 MODULES 
 
1.   An Introduction to Clinical Research 
 
2.   An Overview of ICH GCP 
 
3.   Code of Federal Regulations 
 
4. FDA 21 CFR Part 11 ( Part 1 and 2) 
 
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REGULATORY TRAINING 
 
Regulatory training allows you to understand and apply the FDA regulation guidelines to each individual 
trial you will supervise after your Clinical Research Training. 
 
 
15 MODULES 
 
1.    Regulatory Documents in Clinical Research 
 
 2.    Regulatory Affairs 
 
3.    Essential Regulatory Documents Guidance and Binder Tabs -Part 1 
 
 4.    Essential Regulatory Documents Guidance and Binder Tabs - Part 2 
 
 5.    Electronic Regulatory Submission and Review 
 
 6.    Financial Disclosure- Duties and Strategies for Clinical Studies 
 
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