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Module 2: Research protocol and protocol-related documents
Learning outcomes
What is a research protocol?
Basic structure of a research protocol
Protocol-related documents
Research team profile
Budget
Gantt chart
Data collection tools
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Participant information sheet, Consent and Assent form
Insurance and indemnity
Information sheet of investigational drugs or devices
Safety or adverse event reporting plan
Data monitoring plan
Emergency unblinding plan
Post-study care plan
Other standard operating procedures (SOP)
Other useful resources
Key messages
Self-assessment
Self-assessment (2)
Course feedback
References
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