Clinical Trial Research Ethics Approval Form

Study Title Principal Investigator Name Principal Investigator Email Institution / Organization Department Study Start Date Study End Date

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Study Overview / Rationale Study Objectives Study Design / Methods Participant Inclusion Criteria Participant Exclusion Criteria Estimated Number of Participants Informed Consent Process Description Risk Assessment and Mitigation Data Management and Confidentiality Funding Source Additional Ethical Considerations Attach Relevant Documents (Protocol, Consent Forms, etc.)