4. Regulatory Authority (RA)/Competent Authority (CA)

4.1 Documents and Format Required for RA/CA Review and Approval

4.2 Timeline for RA/CA Review and Approval Process

4.3 Permission for Electronic Submission

4.4 Requirement for Applicant to be Principal Investigator (PI)/Chief Investigator (CI)

4.5 RA/CA Submission Process for Clinical Trial Approval

4.6 Written Acknowledgment of the Submitted Application by RA/CA

4.7 RA/CA fee

4.8 Mode of payment to RA/CA

4.9 Guidance Tool for Making Electronic Applications to RA/CA

4.10 Requirements for Screenshots/Mock Screens for Participant-facing Materials