Training » Course Modules
Course Modules
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Course Module
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Course
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Introduction to drug development
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Day 1
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Introduction to clinical research
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Day 1
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Introduction to clinical research regulations
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Day 1
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Introduction to ethical principles in clinical research
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Day 1
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Clinical trial planning & resourcing
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Day 1 (& refresher)
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Essential documents
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Day 1 (& refresher)
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Role of the ethics committee in clinical research
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Day 2
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Role of the investigator in clinical research
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Day 1 (& refresher)
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Role of the sponsor in clinical research
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Day 2
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Role of the monitor in clinical research
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Day 2
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Introduction to GCP audits and inspections
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Day 2
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Informed consent process
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Day 1 (& refresher)
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Safety (adverse event) Reporting
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Day 1 (& refresher)
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Clinical trial protocols
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Day 2
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Preparation for a GCP audit/ inspection
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Day 3
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Common GCP audits/ inspections findings
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Day 3
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