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.