Course Content
Introduction
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3 Topics
Introduction 0.1
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Introduction 0.2
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List of Acronyms
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GCP Definitions
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7 Topics
Definition of Informed Consent
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Impartial Witness (IW)
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Legally Acceptable Representative (LAR)
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Legally Acceptable Representative (LAR) role explanation
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Vulnerable trial participants Definitions (per ICH-GCP E6 [R3])
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Examples of Vulnerable trial participants
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Summary in Practice 1:
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Origins and history of IC
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5 Topics
History and Origins of IC
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Nuremberg Code
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Declaration of Helsinki
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The Belmont Report
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WHO International Ethical Guidelines for Biomedical Research Involving Human trial participants
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ICF Requirements
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2 Topics
ICF Requirements
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Additional ICF Requirements
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Responsibilities of the PI
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2 Topics
Responsibilities of the PI
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Responsibilities of the PI Continued
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Responsibilities of the Monitor
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2 Topics
Responsibilities of the Monitor
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Responsibilities of the Monitor continued
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IC Discussion with the trial participant (and/or LAR)
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4 Topics
IC Discussion with the trial participant (and/or LAR)
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IC Discussion compliance details
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IC Discussion responsibilities
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Ensuring the trial participant (and/or LAR) Understands
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Documentation of IC Process
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3 Topics
Documentation of IC Process – Source documentation requirements
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Documentation ICF versions and logs
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Signature scenarios and correct completion examples
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Additional Considerations
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2 Topics
Additional Considerations and Preparation
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Assessment – Quiz Questions and Answers
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Final Quiz
Informed Consent Competency Assessment
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