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IRB Info and Documents

  • April 8, 2022

General IRB Information

  • CHANGE-AFib IRB Overview

Central IRB Information

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

Local IRB Information

  • CHANGE-AFib Main Study Approval (03Nov2021)
  • Trial Protocol: English, Signature page
  • ICF Template: English
  • CHANGE AFib One-pager
  • Patient Brochure: English, Spanish
  • Provider Pocket Card
  • MAFSI Questionnaire: English, Spanish
  • AFEQT Questionnaire: Instructions, English, Spanish
  • Multaq Prescribing Information
  • IND Exemption Notification
  • CHANGE-AFib Medical Record Release Form V1 (16Sep2021)
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CHANGE AFib is a collaboration between the American Heart Association and the Duke Clinical Research Institute, with support from Sanofi US.

ClinicalTrials.gov Identifier: NCT05130268