The Getting Started Process for Confirmed BOOST-3 Spokes/Sites
Sites interested in participating in BOOST-3 are required to complete this survey.
After BOOST3 Leadership has confirmed your site, start working on the getting started tasks:
ER-CIRB: Resources and steps for relying on an external cIRB
BOOST-3 Site Milestone Document
Sponsor Continuing Review Approval Nov2019
Protocol Version 3
EFIC Resources
- EFIC ER-CIRB Review Process
- FAQs regarding EFIC & Advarra as the cIRB
- EFIC Plan - All cIRB EFIC material can be found in the Appendix.
- 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
WebDCU Resources
- SIREN WebDCU User Manual
- 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)
Training
Site Readiness
BOOST-3 Study Team Members
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.
General Study Start-Up and Regulatory Assistance
Contact: BOOST-contact@umich.edu or (734) 232-2142 to reach a Site Manager.
Bookmarks
Bookmark these most commonly referenced SIREN-NETT-affiliated websites:
SIREN Standard Operating Procedures
Are you a SIREN-affiliated Hub bringing up an BOOST-3 Spoke?
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.
Are you an ancillary BOOST-3 Hub?
- 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.