3. Ethics Committee (EC)/ Institutional Review Board (IRB)

3.1 Documents Needed for EC/IRB Review and Approval

3.2 Turn-around Time for EC/IRB Review and Approval Process

3.3 Availability of Fast-track or Expedited Review Process

3.4 Requirement for Registration and/or Accreditation/Approval by RA/CA

3.5 Frequency of EC/IRB meetings

3.6 Additional Approval Apart from EC/IRB (e.g., scientific committee, subject matter expert committee, etc.)

3.7 Submission Process of EC/IRB for Clinical Trial Approval

3.8 EC/IRB Fee

3.9 Mode of Payment to EC/IRB

3.10 Guidance Tool for Electronic Applications to EC/IRB 

3.11 Mock Screens/Screenshots of Participant-facing Material on the App and the Language Required

3.12 Periodic Study Reporting

3.13 Template Availability for ICF and/or Other Participant-facing Materials

3.14 Participant Compensation including Clinical Study-related Injury

3.15 Specific Safety Reporting Requirements