Toolbox

Ancillary Studies 

Consent 

COVID-19 (New 4-9-20)

IRB (Updated 3-25-20)

Moberg Device 

Licox Brain Tissue O2 Monitor 

Raumedic MPR2 logO device 

Reliability of PbtO2 Measurements

Physician and RN Tools 

Slide Template and Presentations (Updated 3-26-20)


 

Ancillary Studies 

Approval Process Policy

 

Consent 

Master Informed Consent Form 

Tracked Changes Version of Master ICF

Electronic Informed Consent SOP 

Short Form Instructions 

Short Form Collection:

English

Spanish

Korean

Vietnamese

Traditional Chinese

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COVID-19 (NEW 4-9-20)

SOP for Remote Screening and Enrollment

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IRB 

Full HIPAA Waiver (NEW 3-25-20)

Sponsor Continuing Review Approval Nov2019 

ER-CIRB Approval Letter for Protocol, EFIC and ICF 

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Slide Template and Presentations

Slide Template:  Standard (4:3)    Widescreen (16:9)

BOOST-3 General Trial Information 

NOTE: This set is NOT ER-CIRB-approved and should NOT be used for Community Consultation/Public Disclosure. A separate slide set for use with community groups is available in the EFIC Plan Appendix. 

 

Study Coordinator Education Spotlight (3-3-20): (NEW 3-26-20)

Helpful Hints for Interpreting and Entering Tier Interventions

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Licox Brain Tissue O2 Monitor 

BOOST-3 Licox Blinding video

NOTE: You need to push “Accept” when you go to turn the Alarms off before going back to the Main Screen. 

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Raumedic MPR2 LogO Device 

Universal Quick Guide (for BOOST-3 accounts ONLY)

NOTE: In order for each site to use the Guide effectively, each MPR2 will have to have the BOOST-3 software on it. Blinding information is also included in this Guide.

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Moberg Device 

Device Setup

Setup QuickCards

Setup Procedures for Device and CarePath 

Device Operations and Features

Password Setup

Finding the System Information

What is a CNS Monitoring Protocol?

Editing Protocols on the CNS Monitor

List of Pre-Defined Event Names

End-A-Session

Archiving Subject Data at the End of a Monitoring Session

Data Management After Subject Discharge

 

Moberg Data Upload 

 

Instructional Videos for CNS Monitor and CarePath 

1) Initial setup

2) Start monitoring

3) Start CarePath

4) CarePath Steps

5) Blinding

6) Patient discharge

 

Tips for using CNS Monitor and CarePath (from Study Coordinator Educational Spotlight 2-4-20) 

 

How to Collect Additional Information from CNS Monitor (from Study Coordinator Educational Spotlight 2-4-20) 

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Reliability of PbtO2 Measurements 

Coming soon

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Physician and RN Tools 

CST Reference Ranges 

The CST reference ranges can be posted at the beside or provided to the clinical team to use as a check to maintain CST guidelines. If values outside these ranges are not treated, then the treating physician should document the rationale for leaving those values untreated. 

Daily Checklist 

The daily checklist is an optional tool for study coordinators to use as a reminder/prompt for things to check each day while the subject is being monitored. 

Enrollment Checklist 

The study enrollment checklist is an optiolnal tool that can be used as a reference for screening and enrolling subjects. 

Inclusion/Exclusion Pocket Cards 

Inclusion (front)    PDF   InDesign

Exclusion (back)  PDF   InDesign

Nursing Documentation Tool - OPTIONAL tool to document tier treatments for all scenarios 

Two formats available: Excel (legal size paper)    Word (standard size paper)

Pocket Cards (FiO2 challenge, Scenarios B-D, Removal or Replacement of Probes) 

Tier Interventions Menu 

Two formats available: Large (2-page)    Small (1-page)

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