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New Study Coordinator Workshop
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GCPs for Study Coordinators
Today s Workshop
ACCME Requirement: CMEs
ANCCCA Requirement: CEUs
The World of GCPs
Purpose of Module
Module Outline
Common Acronyms
GCPs Regulations Book
Official GCP Definition (ICH)
Department of Health and Human Services
US GCPs (Regulations) Gold Ethics Standards
Office of Human Research Protection
GCP Training at
Food and Drug Administration
Good Clinical Practice Program
US GCPs [Regulations] Gold Standards
US GCPs [Regulations] Gold Standards
US GCPs [Guidances] Gold Standards
US GCP Document: 1572
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US GCP Document: 1572
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Obligations of Investigators
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