PROTOCOL SUBMISSIONS

for new protocol REQUESTS:

PROTOCOL REQUEST INSTRUCTIONS:

These protocol submission guidelines are required to facilitate the protocol submission and approval process, and for maintaining accurate inventory of multiple versions of all BSL-3 protocols. 

The following template provides a standardized format for the information required, however content may be modified as necessary to meet the specific aims of the study and development of the protocol.  

Each Protocol Submission consists of two parts:

1. Protocol Submission Form:  This form must be completed and submitted along with each protocol. This form contains prompts for required administrative information. 

2. Main Body and Appendices of the protocol:  This document template includes instructions, as well as the standard format and language for submitting your protocol.

Both the Protocol Submission Form and the Main Body of the Protocol with Appendices (along with any supporting documents) must be submitted to the BSL3 RA for review by the BSL3 Advisory Committee.  Submissions are due 14 days before the next scheduled Advisory meeting.

For protocol amendments, a “Summary of Changes” should be provided as the first page (page i) of the document, as indicated in the template.  The Summary of Changes must provide hyperlinks or specific reference to all changes in the protocol.  If there are no changes or if this is the first submission, please delete and do not submit that page.  

All Protocol Template instructions and prompts are in blue italics.  Please delete the italicized text and replace it with your entry in your formatted text. 

Emphasized instructions or information will have red highlighting. 

All sections in the Protocol Template should be retained to facilitate rapid review.  If a section is not appropriate or needed for your protocol, please delete the text in blue italics and insert “Not Applicable” after the section number.  

Depending on the on the type of submission, format your information as follows:

• No highlighting – for original text

• Yellow highlighting – for changes from the last submitted protocol

• Green highlighting – for additions from the last submitted protocol

For reviews, changes or corrections, please retain the ORIGINAL TITLE FOR ALL VERSIONS OF THE SAME PROTOCOL for ease of identification and review.  If you wish to change the protocol title, please request this change separately.  Each protocol submission must have a corresponding version number and version date.  As reviews or changes are submitted and approved (Summary of Changes page required), the version number and version dates must be updated.  

A Letter of Approval will be filed when the protocol is approved

Note that we cannot accept MS Word files that:

5. 1. are read-only

   2. are password protected or contain macros

   3. are saved with a file extension other than .doc or docx

For problems or questions encountered with any submission documents, please contact the BSL-3 RA by e-mail (smm39@case.edu).

EXAMPLE - PROTOCOL FORMAT:

FULL TITLE: (Format Arial font, size 16, bold)

INTRODUCTION (optional)

Please insert primary protocol objectives or leave this section blank.

1. PATHOGEN(S)

Name of all pathogen(s) that will be used for this protocol

2. EQUIPMENT OR MATERIALS REQUIRED

Provide a list of all the materials and equipment you will need for your project here.

3. METHODS

Provide your full protocol here.  You may just copy and paste.  

Please do not include BSL-3 SOPs here.  These should be listed as a separate section and referred to in your protocol.

4. REFERENCES

Please insert all relevant references here or leave this section blank.

5. BSL-3 STANDARD OPERATIONS

These are the SOPs that are specific to your work.  Please consult the most current guidelines for this section. 

REMOVING ITEMS FROM THE LAB (IF NEEDED)

YOU MUST HAVE APPROVAL BEFORE REMOVING PATHOGENS FROM THE LAB IN ANY STATE!  

Please insert all the necessary protocols that you will use to remove items from the lab, if needed.  

• If moving items to another BSL-3 lab, this should include your SOP for moving items between BSL-3 labs.

• If moving items to a BSL-2 or lower level, this should include your SOP WITH references for inactivation or attenuation that allows your pathogen at a lower safety level.   

REMOVAL OF PATHOGENS FROM THE LAB FOR ANY REASON REQUIRES APPROVAL 

REMOVAL OF PATHOGENS FROM THE LAB MUST BE DOCUMENTED EVERY TIME BY COMPLETING THE FORM FOR REMOVING ITEMS FROM THE LAB.