Please click on the links below for helpful information pertaining to each category:     

1572, FWA & CLIA      

Chamber Resources 

Clinical Resources 

Clinical Standardization Guidelines




Informed Consent Process 


IRB (Updated 10-14-20)

Readiness Checklist 

Short Forms (New 10-7-20)






1572, FWA & CLIA

FDA Form 1572 (updated 2/16)

1572 Guidelines for Spokes

SIREN-NETT - FWA Requirements for Spokes

FWA Look up:

CLIA Look up:



Chamber Resources 

Chamber and Subject Log v.6

Training for Chamber and Subject Log 

Multiplace Readiness Checklist 

HBO Checklist 

Magellan Ventilator: 

Site Training Video

Competency Validation  

Refresher Training Video 

Hyperbaric Safety Pause Checklist 

Example of Laminated Card - NBH x 4.5 - Example of laminated cards that identify the treatment group, along with start and stop times. These can be placed in and around the chamber room.

Example of Laminated Card - Post HBO 3hrs NBH - Example of laminated cards for NBH group. Study teams can affix these cards to the ventilator and be marked with dry erase markers to ensure that the FiO2 is returned to baseline after the 3-hour period has completed.

Monoplace Safety Technical Bulletins:

Ohmeda Volume Monitors and Battery Use

Charging Ohmeda Batteries 

Ohmeda Battery Charging Cradle 

Witt Oxygen Blender and Delta P

Shutting Down the Manifold System

Removing the O2 Sample Flow Indicator 

Technical Memo:

Use of Camino ICP Monitor in Multiplace Hyperbaric Chamber 

Serving the Witt Oxygen Blender (Monoplace) 

HYCEP Procedure:

This is a two-part educational activity:

1. Part one is a video demonstration designed to be a short and effective means of teaching about the risks associated with VAP and demonstrating a procedure to help reduce or mitigate these risks.

HOBIT Trial “HYCEP” Procedure to Reduce Incidents of VAP (Ventilator Associated Pneumonia)

2. Part two is a skills and competency validation that we strongly recommend be completed by all who will be involved with exchanging the ETT cuff from air to normal saline.

Training and Competency Validation for Performing the “HYCEP” Procedures 

HYCEP Attestation 



Clinical Resources 

Clinical Team Training 

Badge Buddy (Hennepin County Medical Center)

Clinical Team Training PowerPoint (Hennepin County Medical Center)

Investigators Meeting PowerPoint (Modified by: University of Iowa Hospitals and Clinics)

Ancillary Team Letters 

"Dear Nurse" (Hennepin County Medical Center) - The study team can customize, print and provide this letter to the ICU staff that outlines the patient’s treatment group, important reminders, and other pertinent information.

"Dear RT" (Hennepin County Medical Center - The study team can customize, print and provide this letter to the RT staff that outlines the patient’s treatment group, important reminders, and other pertinent information.

Pocket Card 

Front    Back

Poster for ED 

Simulation Video Examples 

Detroit Receiving 

Tips and Lessons Learned (Hennepin County Medical Center) - This highlights HCMC’s lessons learned and helpful tips from their first 2 enrollments. - This website has calculators to quickly calculate GCS, Serum Osmolality, MAP, and CPP that are useful for the trial. 

High ICP and Low Brain Tissue PO2 Cheat Sheet (Hennepin County Medical Center) - This can be placed on the monitors during study treatments.




CRF Guidelines




Electronic Informed Consent SOP (description of the central IRB-approved eConsent process)

All HOBIT sites should plan to use the electronic version of the consent form, with paper consent available as a last resort. The eConsent platform, Redcap, has been approved by the central IRB for eConsent use in HOBIT. A demo of the HOBIT eConsent can be found here.

A unique eConsent form link for your site will be provided to you after your site application has received central IRB approval. 

e-Consent Checklist 




DSMB Roster



Informed Consent Process 

Informed Consent Process Overview Video

Objective: To illustrate how a site (Hennepin County) that is very successful at enrolling subjects approaches the informed consent process for HOBIT. This video will demonstrate how to present the HOBIT study to an LAR who may be medically illiterate and may have acute stress and grief from the patient’s condition.




HOBIT Grant (excluding budget) 

Human Subjects

IND Approval Letter




ER-CIRB Issued Documents: 

Informed Consent Form - Approved 12 Oct 2020 - This new form contains provisions for collecting blood and CSF samples. (New 10-14-20) 

IRB Approval Letter (New 10-14-20) 

Version 5 – IRB Approval Letter for Protocol 5 Dated April 5th, 2019 and GOSE Video Recording Script 

GOSE Video Recording Script 

Version 4 – IRB Approval Letter for Protocol 4 and Consent Version 29 Jan 2019 

Initial IRB Approval Letter


yperbaric Oxygen Information for LAR 

Sponsor Recruitment Material Approval Notice 

Sponsor Subject Material Approval 13 Nov 2019  

Certified Letter to LAR (for Lost to Follow Up)  

GOSE Schedule of Assessments Handout 

Sponsor Subject Material Approval Notice Jan 10, 2020 

Ceding Resources:

Smart IRB Cheat Sheet



Readiness Checklist 

Readiness Checklist 

Tracked Changes 




To be utilized and completed during the simulation:

HBO Checklist 

Hyperbaric Safety Pause

Chamber and Subject Log v.5 

Training for Chamber and Subject Log 


The following are to assist with planning the simulation, and are NOT meant to be prescriptive, but used as a guide:

Case 1: Longitudinal Simulation Scenario Template + Case Stimuli

Case 2: Complication Simulation Scenario Template + Complication Stimuli

LRT Identification Tool -Use this form during the debrief to document your site's equipment, knowledge, or process issue that are identified via running the sim and debriefing it.

Sim Video Checklist: Sites can use this checklist to work through the requirements of the sim, and CCC leadership uses it as a guide when reviewing each sites’ sim video.




WebDCU™ link

Regulatory Parameters Document


WebDCU Cheat Sheet for Study Team Member Changes 


Jodie Riley (843) 792-1453 and Teldon Alford (843) 792-3980 


ER-CIRB Initial Site Submission Parameters