Toolbox

 

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

1572, FWA & CLIA      

Chamber Resources (Updated 9-14-18)

Clinical Resources (Updated 9-18-18)

Clinical Standardization Guidelines

CRFs  

e-Consent 

DSMB 

IND 

IRB (Updated 6-14-18) 

Readiness Checklist (Updated 8-23-18)

Simulation (Updated 8-1-18)

WebDCU™ (Udated 6-1-18)

 


 

 

1572, FWA & CLIA

FDA Form 1572 (updated 2/16)

1572 Guidelines for Spokes

SIREN-NETT - FWA Requirements for Spokes

FWA Look up: http://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc

CLIA Look up: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information.html

top

 

Chamber Resources 

Chamber and Patient Log (Updated 6-25-18)

Multiplace Readiness Checklist (New 6-13-18)

HBO2 Checklist

Magellan Ventilator 

Site Training Video

Competency Validation  (Updated 7-24-18)

Hyperbaric Safety Pause Checklist (Updated 8-1-18)

Example of Laminated Card - NBH x 4.5 (New 9-14-18) - 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 (New 9-14-18) - 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.

top

 

Clinical Resources 

Clinical Team Training (New 4-30-18)

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 (New 8-23-18)

"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 (New 4-26-18)

Front    Back

Poster for ED (New 4-26-18)

Simulation Video Examples (New 7-17-18)

Detroit Receiving 

Tips and Lessons Learned (Hennepin County Medical Center) (New 8-23-18) - This highlights HCMC’s lessons learned and helpful tips from their first 2 enrollments.

https://www.mdcalc.com/ (New 9-18-18) - This website has calculators to quickly calculate GCS, Serum Osmolality, MAP, and CPP that are useful for the trial. 

top

 

CRFs

CRF Guidelines

top

 

eConsent (New 5-10-18)

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. 

top

 

DSMB

DSMB Roster

top

 

IND 

HOBIT Grant (excluding budget) (New 4-6-18)

Human Subjects

IND Approval Letter

top

 

IRB 

cIRB Issued Documents:

IRB Approval Letter for Protocol and Consent Changes (Updated 6-14-18)

Initial IRB Approval Letter

Consent Form (US and Canada) (Updated 6-14-18)

Short Form Collection

Hyperbaric Oxygen Information for LAR (NEW 8-30-18)

Sponsor Recruitment Material Approval Notice (NEW 8-30-18)

Ceding Resources:

Smart IRB Cheat Sheet

top

 

Readiness Checklist 

Readiness Checklist   (Updated 8-23-18)

Tracked Changes

top

 

Simulation

To be utilized and completed during the simulation:

HBO Checklist

Hyperbaric Safety Pause

Chamber and Patient 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 (Updated 8-1-18): 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.

top

 

WebDCU™

WebDCU™ link

Regulatory Parameters Document

CRFs 

WebDCU Cheat Sheet for Study Team Member Changes (New 5-7-18)

Support:

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

 

cIRB Initial Site Submission Parameters (New 6-1-18)

top