1. Study Identification

Study Title Protocol/Study ID Sponsor (if any) Principal Investigator Affiliation Email Phone

2. Study Details

Study Objective Study Design Study Location(s) Sample Size Study Duration Study Population

3. Ethical Considerations

Informed Consent Process Risks and Benefits Confidentiality Measures Involvement of Vulnerable Groups (if any)

4. Regulatory Approvals

Regulatory Approvals (if any) Previous Ethics Approval (if any)

5. Attachments

List of Attachments (e.g., protocol, patient information sheet, consent form, recruitment materials)