General IRB Information
Central IRB Information
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)
- 2023 Continuing Review Approval (22Sept2023)
- 2022 Continuing Review Approval (12Oct2022)
- Initial IRB Approval (03Nov2021)
- DSMB Reports: May 2023 Open Session
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)