Toolbox

 

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

1572, FWA & CLIA      

Chamber Resources (Updated 7-10-18)

Clinical Resources (Updated 7-17-18)

CRFs  

e-Consent 

DSMB 

IND 

IRB (Updated 6-14-18) 

Readiness Checklist (Updated 7-10-18)

Simulation (New 6-26-18)

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

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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

Hyperbaric Safety Pause Checklist (Updated 7-10-18)

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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)

Pocket Card (New 4-26-18)

Front    Back

Poster for ED (New 4-26-18)

Simulation Video Examples (New 7-17-18)

Detroit Receiving 

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CRFs

CRF Guidelines

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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. 

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DSMB

DSMB Roster

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IND 

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

Human Subjects

IND Approval Letter

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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

Ceding Resources:

Smart IRB Cheat Sheet

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Readiness Checklist 

Readiness Checklist   (Updated 7-10-18)

Tracked Changes

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Simulation

Sim Video Checklist (New 6-26-18): 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.

 

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.

 

To be utilized and completed during the simulation:

HBO Checklist

Monoplace Safety Pause

Chamber and Patient Log

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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)

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