Please click on the links below for helpful information pertaining to each category:
Clinical Resources (New 4-30-18)
e-Consent (New 5-10-18)
IND (Updated 4-6-18)
IRB (New 4-6-18)
Readiness Checklist (New 4-25-18)
WebDCU™ (Udated 5-7-18)
FDA Form 1572 (updated 2/16)
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)
Poster for ED (New 4-26-18)
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.
HOBIT Grant (excluding budget) (New 4-6-18)
cIRB Issued Documents:
The following are to assist with planning the simulation, and are NOT meant to be prescriptive, but used as a guide:
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:
Regulatory Parameters Document
WebDCU Cheat Sheet for Study Team Member Changes (New 5-7-18)