Brain Oxygen Optimization in Severe TBI Phase 3: BOOST-3 Study Details at University of Michigan

 
 
 
 
Brain Oxygen Optimization in Severe TBI Phase 3
 
Erin Bengelink
BOOST-3 Site Manager
SIREN CCC, University of Michigan
 
 
BOOST3trial.org
 
Locate study
materials: protocol,
EFIC materials, cIRB
approved ICF,
milestones,
regulatory
parameters
document, MOP
Access training
materials and FAQs
 
  
Getting Started
 
Important
information and
materials for
preparing for
BOOST-3
Useful links to trial
resources
 
  
BOOST-3 Milestones
 
Milestone 1
Task 1: Ceding Request to Local
IRB
Task 2: Electronic Delegation of
Authority 
(eDOA) 
Log
Task 3: Ceding Acknowledgment
from Local IRB
 
 
Milestone 2
Task 4: EFIC Local Context Form
Task 5: Log CC/PD Events
Task 6/7: CC/PD Activities
Task 8: cIRB Site Application
Task 9: eDOA log
Task 10 Readiness checklist/call
 
BOOST-3 Milestones
 
BOOST-3 Regulatory Database: WebDCU
TM
 
 
BOOST-3 regulatory database will serve as the central
repository for all regulatory documents
IRB Approvals and other essential documents will be
available via the database
Automated emails will be sent for expired, expiring, and
missing documents
 
BOOST-3 Regulatory Database: WebDCU
TM
 
Regulatory Parameters Document
 
Outlines all regulatory and training requirements
People Document:  Specific to an individual study team member
 
 
Regulatory Parameters Document
 
Outlines all regulatory and training requirements
Site Document:  Applies to a site/Spoke
 
 
Regulatory Documents for Site
Startup – Site Documents and Forms
 
FWA for your Institution
CLIA Certification
Attestation of Study Team Education and
Training
Ceding Request to Local IRB
Ceding 
Acknowledgment from Local IRB
HSP Requirements
EFIC Results Report
IRB Approval (Advarra)
IRB Approved Informed Consent
(Advarra)
cIRB Tables
Site Overview (SIREN)
Site Regulatory Inspection (SIREN)
Initial Site Submission (BOOST-3)
 
Reminder: Please upload all documents as pdfs in WebDCU
 
Regulatory Documents for Site
Startup – People Documents
 
Reminder: Please upload all documents as pdfs in WebDCU
 
All Team Members
CV
HSP
GCP
Protocol Training
 
 
Applicable Team Members
Medical License
BOOST Data Training
Regulatory Document Training
Blinded Outcomes Assessment
Training
 
 
Regulatory Documents for Site
Startup
 
Electronic Delegation of Authority (eDOA) Log
Completed Readiness Checklist
Send completed readiness checklist to 
boost-
contact@umich.edu
 
Electronic Delegation of Authority (eDOA) Log
 
Readiness Checklist
 
Sites will complete to confirm
regulatory and logistical
readiness
List names of site participants
who will be in attendance
Respond to all questions in
logistics section
Email completed checklist
prior to the call (boost-contact
@umich.edu)
 
Readiness Call
 
A readiness call is the study initiation meeting
Conducted via phone conference
Evaluate and confirm site readiness for study activation
Q&A with trial leadership and CCC
 
 
 
 
 
 
 
 
Readiness Call
 
Site Personnel:   Hub PI and PM, Trial PI, Primary SC. Other
team members are welcome to attend!
BOOST-3 PI, Site Manager, MUSC personnel and other team
members
All participants will receive an appointment request sent to
their calendars with conference line information
 
Post Call – Site Activation
 
 
If action items remain after the readiness call, site personnel
will resolve prior to activation
If no action items, site will be activated and released to
enroll
BOOST-3 study team will be notified via email
 
Ongoing Site Management
 
It is the responsibility of each Hub/Site to maintain
regulatory compliance, inclusive of site documents and
people documents, throughout the duration of the trial
Documents approaching expiration should be reconciled
prior to the expiration date
Study team personnel who are out of regulatory compliance
should not participate in any trial related activities
 
Study Team Changes
 
Add to BOOST-3 Database
Update eDOA
Upload all team personnel documents, trainings and
certifications (eg., CV, medical license)
Study team members cannot begin research related
activities until all of the above have been reconciled.
 
 
 
 
 
 
 
 
 
Who to Contact?
 
For immediate emergency assistance (enrollment, clinical, protocol,
adverse events, etc.), please use the 24/7 BOOST-3 Principal Investigator
Hotline:
855-4-BOOST3 (855-426-6783)
Clinical questions for BOOST3 trial PIs: 
boost-PIs@umich.edu
For non-urgent data entry/WebDCU questions call: 1-866-450-2016
For all other non-urgent questions: 
boost-contact@umich.edu
For all email communications, please include BOOST-3 at the beginning
of the subject line.
 
 
 
 
 
 
 
 
Questions?
 
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Explore the BOOST-3 trial led by Erin Bengelink, focusing on brain oxygen optimization in severe Traumatic Brain Injury (TBI) Phase 3. Discover study materials, milestones, regulatory parameters, and training resources to facilitate your involvement in this crucial research project. Access the BOOST-3 Regulatory Database, essential documents, and detailed site startup information, ensuring seamless progress in this vital study.


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  1. Brain Oxygen Optimization in Severe TBI Phase 3 Erin Bengelink BOOST-3 Site Manager SIREN CCC, University of Michigan

  2. BOOST3trial.org Locate study materials: protocol, EFIC materials, cIRB approved ICF, milestones, regulatory parameters document, MOP Access training materials and FAQs

  3. Getting Started Important information and materials for preparing for BOOST-3 Useful links to trial resources

  4. BOOST-3 Milestones Milestone 1 Task 1: Ceding Request to Local IRB Task 2: Electronic Delegation of Authority (eDOA) Log Task 3: Ceding Acknowledgment from Local IRB

  5. BOOST-3 Milestones Milestone 2 Task 4: EFIC Local Context Form Task 5: Log CC/PD Events Task 6/7: CC/PD Activities Task 8: cIRB Site Application Task 9: eDOA log Task 10 Readiness checklist/call

  6. BOOST-3 Regulatory Database: WebDCUTM

  7. BOOST-3 Regulatory Database: WebDCUTM BOOST-3 regulatory database will serve as the central repository for all regulatory documents IRB Approvals and other essential documents will be available via the database Automated emails will be sent for expired, expiring, and missing documents

  8. Regulatory Parameters Document Outlines all regulatory and training requirements People Document: Specific to an individual study team member

  9. Regulatory Parameters Document Outlines all regulatory and training requirements Site Document: Applies to a site/Spoke

  10. Regulatory Documents for Site Startup Site Documents and Forms FWA for your Institution IRB Approval (Advarra) CLIA Certification IRB Approved Informed Consent (Advarra) Attestation of Study Team Education and Training cIRB Tables Ceding Request to Local IRB Site Overview (SIREN) Ceding Acknowledgment from Local IRB Site Regulatory Inspection (SIREN) HSP Requirements Initial Site Submission (BOOST-3) EFIC Results Report Reminder: Please upload all documents as pdfs in WebDCU

  11. Regulatory Documents for Site Startup People Documents All Team Members Applicable Team Members CV Medical License HSP BOOST Data Training GCP Regulatory Document Training Protocol Training Blinded Outcomes Assessment Training Reminder: Please upload all documents as pdfs in WebDCU

  12. Regulatory Documents for Site Startup Electronic Delegation of Authority (eDOA) Log Completed Readiness Checklist Send completed readiness checklist to boost- contact@umich.edu

  13. Electronic Delegation of Authority (eDOA) Log

  14. Readiness Checklist Sites will complete to confirm regulatory and logistical readiness List names of site participants who will be in attendance Respond to all questions in logistics section Email completed checklist prior to the call (boost-contact @umich.edu)

  15. Readiness Call A readiness call is the study initiation meeting Conducted via phone conference Evaluate and confirm site readiness for study activation Q&A with trial leadership and CCC

  16. Readiness Call Site Personnel: Hub PI and PM, Trial PI, Primary SC. Other team members are welcome to attend! BOOST-3 PI, Site Manager, MUSC personnel and other team members All participants will receive an appointment request sent to their calendars with conference line information

  17. Post Call Site Activation If action items remain after the readiness call, site personnel will resolve prior to activation If no action items, site will be activated and released to enroll BOOST-3 study team will be notified via email

  18. Ongoing Site Management It is the responsibility of each Hub/Site to maintain regulatory compliance, inclusive of site documents and people documents, throughout the duration of the trial Documents approaching expiration should be reconciled prior to the expiration date Study team personnel who are out of regulatory compliance should not participate in any trial related activities

  19. Study Team Changes Add to BOOST-3 Database Update eDOA Upload all team personnel documents, trainings and certifications (eg., CV, medical license) Study team members cannot begin research related activities until all of the above have been reconciled.

  20. Who to Contact? For immediate emergency assistance (enrollment, clinical, protocol, adverse events, etc.), please use the 24/7 BOOST-3 Principal Investigator Hotline: 855-4-BOOST3 (855-426-6783) Clinical questions for BOOST3 trial PIs: boost-PIs@umich.edu For non-urgent data entry/WebDCU questions call: 1-866-450-2016 For all other non-urgent questions: boost-contact@umich.edu For all email communications, please include BOOST-3 at the beginning of the subject line.

  21. Questions?

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