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Module 8: Ethics review
Learning outcomes
Indications for ethics review
1. Initial ethics application
Evaluation criteria of the ethics committee
Minimal risk studies vs. More-than-minimal risk studies
Expedited (delegated) review
Full board review
Attending an ethics review meeting
After receiving the committee’s decision
2. Protocol amendments
Protocol amendment (2)
3. Protocol non-compliance (self-reporting)
Protocol non-compliance (2)
4. Adverse event reporting
Adverse event reporting (2)
5. Progress report
6. Early study termination report
7. Study closure report
Site inspections
Other useful resources
Key messages
Self-assessment
Course feedback
References
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