Participant Reimbursement Policy
Reliability of PbtO2 Measurements
Slide Template and Presentations
Tracked Changes Version of Master ICF
Electronic Informed Consent SOP
SOP for Remote Screening and Enrollment
Instructions for obtaining and uploading an FWA
Sponsor Continuing Review Approval Oct 2021 (NEW 10-26-21)
Sponsor Continuing Review Approval Nov 2020
Sponsor Continuing Review Approval Nov 2019
ER-CIRB Approval Letter for Protocol, EFIC and ICF
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):
Helpful Hints for Interpreting and Entering Tier Interventions
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.
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.
Device Setup
Setup Procedures for Device and CarePath
Device Operations and Features
Finding the System Information
What is a CNS Monitoring Protocol?
Editing Protocols on the CNS Monitor
List of Pre-Defined Event Names
Archiving Subject Data at the End of a Monitoring Session
Data Management After Subject Discharge
Moberg Data Upload (Updated 9-25-20)
Instructional Videos for CNS Monitor and CarePath
5) Blinding
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)
Reliability of PbtO2 Measurements
Coming soon
Participant Reimbursement Policy
BOOST-3 IRB Approval of Reimbursement Policy
BOOST-3 Participant Reimbursement
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.
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.
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
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)
Protocol (Last Updated 12-20-21)
BOOST-3 Study Protocol - Version 3
Redline BOOST-3 Study Protocol - Version 3
BOOST-3 Study Protocol Revision Rationale
BOOST-3 Sponsor Protocol Modification Approval Notice - December 2021