Getting Started
Welcome to BOOST-3! This page will guide you through the initial steps to set up your site for participation in the study. Here, you’ll find key information on regulatory requirements, training, protocol certification, and essential study documents. Follow the outlined steps to ensure your site is fully prepared to enroll participants and conduct the study successfully.
Interested in joining the BOOST-3 trial? Visit our Interested in Joining BOOST-3 page for more information!
Step 1: Create a UM Friends Account (if you don’t already have one)
New study team members need a UM Friend Account to access all of the BOOST-3 and Network trainings and resources. Click here for instructions on how to create one.
Step 2a: Begin start-up activities found in the BOOST-3 Site Milestone Document
Step 2b: Review the BOOST-3 WebDCU User Account & Regulatory/Essential Document Process Guide
Step 2c: Create Study Team Member Accounts in WebDCU (BOOST-3)
Regardless of whether the study team member ever expects to access the BOOST-3 WebDCU database, each study team member must be added to WebDCU before the trial can start at the clinical site. The site/spoke BOOST-3 PSC has access to complete this step.
Please refer to the BOOST-3 WebDCU User Account & Regulatory/Essential Document Process Guide.
Step 3a: Create an eDOA Log (electronic Delegation of Authority Log) in WebDCU (BOOST-3)
The site/spoke BOOST-3 PSC or PI will have access to complete this step. Select the role and responsibilities that each site team member has been delegated to by the PI. The eDOA must be submitted in order for regulatory document requirements to populate for study team members.
Please refer to the BOOST-3 WebDCU User Account & Regulatory/Essential Document Process Guide.
Step 3b: Required Trainings for WebDCU and BOOST-3 using the Regulatory Parameters Document
Step 3c: Complete Regulatory Document Records in WebDCU
All team members MUST be added to the 1) BOOST-3 Database AND 2) the eDOA, BEFORE all regulatory documents can be fully displayed for completion, please see above.
ER-CIRB: Resources and steps for relying on an external cIRB
BOOST-3 Site Milestone Document
Sponsor Continuing Review Approval Nov2019
Protocol Version 3
Consent Updated 2-4-25
FAQs regarding EFIC & Advarra as the cIRB
EFIC Plan – All cIRB EFIC material can be found in the Appendix.
Specific EFIC related ideas during COVID 19
EFIC Forms Resource Guide (Local Context, CC & PD Form) – Please use this document as a guide for navigating to and completing the Local Context Form, and the CC & PD Form fields in WebDCU.
cIRB-Approved Site EFIC Plans
- Harborview and UCSF
BOOST-3 WebDCU User Account & Regulatory/Essential Document Process Guide
Regulatory Parameters Document (Sites’ guide to regulatory, EFIC and cIRB submission field capture in WebDCU)
Please visit our Education and Training page for the complete list of trainings.
Contact: BOOST-contact@umich.edu or (734) 232-2142 to reach a Site Manager.
Consult the Hub Management of Spokes SOP.
The Hub is responsible for making sure all the spoke tasks are met. However, the Hub can tailor the process to meet their Hub/Spoke Complex relationship in accordance with the Hub/Spoke Complex SOP.
Please note: If your Hub will be an actively enrolling site, it will be considered a spoke in the WebDCU regulatory and study databases. Instructions for spokes below would then apply to the Hub as well.
You will also be considered a spoke in the WebDCU regulatory and study databases. Instructions for spokes below apply.
Enter all spoke study team members into the WebDCU BOOST-3 database for their roles in BOOST-3 in the Study Spoke Team Member Request table. You will not be ready to upload documents for team members until this occurs.
While preparing your site CIRB application, People and Spoke regulatory documentation should be entered into the WebDCU study database per the BOOST-3 Regulatory Parameters Document. The goal is to be ready to enroll, including being regulatory and training compliant as documented in WebDCU, prior to study CIRB approval. Please check with your Hub contact to confirm what your Hub/Spoke complex process will be for documenting and maintaining regulatory compliance in the WebDCU study database.
When you are regulatory ready, the Hub should then contact their SIREN Site Manager for BOOST-3, to schedule a readiness call.