Clinical Trial Ethics Approval Application

1. Study Information

Study Title Protocol Number Sponsor Name

2. Principal Investigator Details

Name Affiliation Email Phone Number

3. Study Summary

Brief Description Objectives

4. Study Design

Type of Study Number of Subjects Inclusion Criteria Exclusion Criteria

5. Ethical Considerations

Risks and Mitigation Benefits Consent Process

6. Additional Information

Confidentiality Data Management Declarations