IRB Info and Documents

General IRB Information

• CHANGE-AFib IRB Overview

Central IRB Information

• CIRBI QuickSteps CIRBI Account Registration
• CIRBI QuickSteps Submitting an Investigator Application

IRB Approval

• CHANGE AFib Protocol V4.0 Main Study IRB Approval (26MAY2023)
• CHANGE AFib Protocol V3.0 Main Study IRB Approval (22Mar2023)
• REVISED CHANGE AFib Protocol V2.0Main Study Approval (29Mar2023), CHANGE AFib Protocol 2.0 Main Study Approval (29Mar2023)
• REVISED CHANGE AFib Protocol V2.0Main Study Approval (07Nov2022), CHANGE AFib Protocol 2.0 Main Study Approval (31Oct2022)
• CHANGE AFib Protocol V2.0 Main Study Approval (31Oct2022)
• 2022 Continuing Review Approval (12Oct2022)
• Initial IRB Approval (03Nov2021)

Local IRB Information

• Current Trial Protocol V4.0 (12May2023): English, Tracked, Summary of changes, Signature page
• Protocol V4.0 ICF Template: English, Tracked Changes
• MAFSI Questionnaire: English, Spanish
• AFEQT Questionnaire: Instructions, English, Spanish
• Multaq Prescribing Information
• IND Exemption Notification
• Recruitment Materials
• CHANGE AFib One-pager
• Patient Brochure: English, Spanish
• Provider Pocket Card
• CHANGE-AFib Medical Record Release Form V2 (16Sep2021)