These guidelines outline the required format for submitting new, revised, or renewal BSL-3 research protocols. Following the standardized template ensures consistent review, accurate version control, and timely approval by the BSL-3 Advisory Committee. 

Protocol requests and all supporting documents must be submitted at least 14 days before the next Advisory Committee meeting.

WHAT TO SUBMIT

Each submission includes three required parts:

1. Protocol Submission Form – Captures administrative and summary information.

2. Main Protocol Document – Describes your study in detail - Download Protocol Template 

3. List of all standard operational procedures (SOPs) and supporting documents.  

Please download this list to select your SOPs

Add your list to this SOP Template using the instructions provided.

SUBMISSION CATEGORIES

New Protocol Requests: 

• Follow full submission instructions and format requirements below

Protocol Reviews (No Changes):

• Submit Protocol Submission Form and Main Protocol Document.  

• Do not include "Summary of Changes" Page

• Follow version formatting requirements (See below)     

Protocol Amendments or Reviews with Changes:

• Include a "Summary of Changes" page with your protocol

• The summary must clearly reference or hyperlink where changes occur in the document

• If there are no changes, delete the page before submission

FORMATTING REQUIREMENTS

1. • Replace all template Instructions in blue italics with your study-specific content and in your preferred text format. 

   • Do not delete section headers. Sections not relevant to your work → write “Not Applicable.”

   • Highlighting for revisions

Type of Text                                           Formatting Requirement                                       

Original text (no changes) No highlighting

Changed text Yellow highlighting

Newly added content Green highlighting

VERSION CONTROL REQUIREMENTS

1. • Keep the same protocol title for all versions
     (Submit an amendment request if the title must change.)

   • Update both version number and version date with each submission

   • For renewals with no changes, keep the version number,however the version date will change.

   • Version Numbering Format:

Change Type                                                                 Example Versions                               

Major revisions or full new version 1.0 → 2.0 → 3.0

Minor changes between major revisions 1.1 → 1.2 → 1.3

DOCUMENT FILE REQUIREMENTS

We cannot accept files that are:

• Read-only

• Password-protected

• Contain macros

• Saved in formats other than .doc or .docx

SUBMISSION PROCESS

Before sending:

• Confirm correct version number and date

• Confirm required highlighting is used correctly

• Ensure template prompt text has been removed

Click here for a full checklist

Submit to: 📧 smm39@case.edu (BSL-3 Research Assistant)

Due: 14 days prior to the next scheduled Advisory Committee meeting.

No work can begin until a letter of approval has been issued and filed.

REVIEW AND APPROVAL

1. Pre-Review:
   BSL-3 RA reviews submission and may return for corrections.

2. Committee Review:
   Advisory Committee reviews finalized version.

3. Approval Outcome:

   Status                        Meaning                                                               NextSteps                                                                         

Approved Fully Accepted A Letter of Approval is issued and filed.

Pending Minor revisions required After revisions, approval is granted without re-review.  

Denied Approval Major revisions or cannot be approved Revised protocol must return to Committee review

No work can begin until a Letter of Approval has been issued and filed.