Training » Course Agendas
Course Agendas
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DAY 1
Principles of GCP, Investigator Responsibilities, Essential Documents
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DAY 2
Principles of GCP, Sponsor Responsibilities, Ethics Committee
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DAY 3
GCP Audit/ Regulatory Inspection Preparation
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REFRESHER GCP TRAINING
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An Overview of Clinical Trials
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Introduction
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Introduction
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Principles of ICH GCP
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Steps in the Drug Development Process
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Ethics Committees Composition, Functions and Operation
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ICH GCP requirement for audit
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Investigator Responsibilities
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Clinical Trial Processes
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Clinical Trial Protocol & Protocol Amendment(s)
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Legal Basis for Inspection
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· Resources (Staff/ Patient Recruitment)
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Parties involved in Clinical Trials
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Investigator's Brochure
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EU Regulatory Inspection Process
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· Training/ Delegation
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Rules Governing Clinical Trials
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Responsibilities of the Sponsor
· Including Monitoring
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FDA Inspection Process
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· Protocol Compliance
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Introduction to ICH GCP
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Workshops throughout
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Common Audit/ Inspection Findings
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· Informed Consent
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Principles of ICH GCP
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Quiz
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Audit Readiness and Audit Preparation Tips
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· Management of Investigational Product
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Investigator Responsibilities
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Workshops throughout
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· Essential documents
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Essential Documents
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Quiz
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· Safety reporting
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Workshops throughout
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Quiz
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