General Guidance
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Protocol Design
- Provisions for Data and Safety Monitoring
- Responsibility for Data and Safety Monitoring
- Criteria in data that should cause a reassessment
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Conducting the study
- Reporting Adverse Events - Social, Behavioral Research
- Reporting Adverse Events - Biomedical Research
- Protocol - Renewal of Approval, Monitoring and Auditing
- Terminating a Study for Safety or Other Concerns
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Post Study