Protocol Review Submission Checklist

BSL-3 Protocol Review SUBMISSON Checklist

Protocol Information

☐ Protocol title is consistent with previous versions

☐ Version number and version date are updated

☐ Protocol Submission Form is completed

☐ Protocol Document is completed and submitted

☐ SOP List is completed and submitted

Summary of Changes (if applicable)

☐ “Summary of Changes” page is included for all protocols with amendments

☐ All modifications are clearly described

☐ Hyperlinks or page references point to each change

☐ If no changes, the Summary of Changes page was removed

Formatting & Highlighting Requirements

☐ Template instructions (blue italics) have been removed

☐ Section headers have not been deleted

☐ “Not Applicable” is written where a section is not relevant

☐ Original text remains un-highlighted

☐ Changed text is highlighted yellow

☐ New text is highlighted green

Personnel & Training

☐ PI information is complete and accurate

☐ New personnel have been added and former personnel removed

☐ All listed personnel are currently BSL-3 certified

☐ All listed personnel are  current in Lab Safety and Biohazard Materials Training (EHS)

Agent & Risk Information

☐ Pathogen(s) are clearly identified, including all strains

☐ Biosafety classification and risk level stated correctly

Approval & Submission

☐ All documents are submitted in .doc or .docx format (no PDFs, no macros)

☐ Protocol was submitted ≥14 days before the Advisory Committee meeting

☐ File naming follows standard convention (e.g., ProtocolTitle_V2.1)

☐ Email submission via Request Form or sent to smm39@case.edu