Clinical Trial Ethics Application

1. Project Details

Project Title Principal Investigator Affiliation / Institution Contact Information

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2. Study Summary

Brief Summary Objectives Methodology Study Location(s)

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3. Participants

Participant Population Inclusion Criteria Exclusion Criteria Number of Participants

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4. Informed Consent

Process for Obtaining Informed Consent

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5. Risks and Benefits

Potential Risks Risk Management / Mitigation Potential Benefits

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6. Confidentiality

Describe how participant information will be kept confidential

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7. Data Management

Data Storage & Security Data Retention & Destruction

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8. Declaration

Declaration by Principal Investigator Date