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PRODUCTS
TRAINING
RESOURCES
RAN INFORMATION
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Pre-test on Terminology and Good Clinical Practices
Part 1: Introduction to Good Clinical Practices
1.1 Ethical Principles of Human Research
1.2 Components of Good Clinical Practices
Part 2: An Overview of Human Research
2.1 The Entities Involved in Human Research
2.2 Overview of the Drug Development Process
2.3 The Clinical Trial Process
Part 3: Applying GCPs in the Clinical Study Process
3.1 The Investigational New Drug Application
3.2 The Investigational Device Exemption
3.3 Development and Review of Protocols and Case Report Forms
3.4 Evaluation and Selection of Investigators
3.5 Informed Consent: Content Requirements & Approval
3.6 IRB/IEC Review and Approval
3.7 The Investigator's Obligations
3.8 The Pre-study Initiation Process and Essential Documentation
3.9 Obtaining and Documenting Informed Consent
3.10 Collecting and Recording Subject Data including Source Documents
3.11 Sponsor Monitoring
3.12 Adverse Event Reporting
3.13 Handling and Documentation for Investigational Products
3.14 Study Closure and Record Retention
3.15 Study Audits
Post-test on Good Clinical Practices
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