For Initial Clinical Trial Application:
- 2-A1: Review Checklist for Initial Review Application
- 2-B. Registration and Application Form
- 2-C. Study Protocol Assessment Form
- 2-D. Informed Consent Assessment Form
INITIAL REVIEW WORKFLOW
For Resubmission:
- 2-A2. Review Checklist for Resubmission
- 2-B. Registration and Application Form
- 2-F. Review of Resubmitted Study Protocol Form
Form Amendments:
- 2-A2. Review Checklist for Resubmission
- 3-A. Study Protocol Amendment Submission Form
- 3-K. Additional Study Materials for Approval Form
For Continuing Review and Reports
- 3-B. Progress Report Form
- 3-C.Continuing Review Application Form
- 3-D. Final Report Form
- 3-E. Study Protocol Deviation or Non-Compliance Report
- 3-F. Early Study Termination Application Form
- 3-H. Serious Adverse Event(s) Report
- 3-J. Study Participant Queries or Complaints
Notes:
- Schedule of VMMC-IRB meeting: every last Friday of the month.
- All documents for review and approval must be submitted 15 days before the scheduled IRB meeting.
*For queries please contact IRB staff to telephone no. (02) 9276426 to 31 local 1368.