- All sites will be required to fully execute a Clinical Trial Agreement (CTA) between the American Heart Association and the Participating Trial Site. This agreement allows the site to participate in the CHANGE AFib trial. The Clinical Trial Agreement details what the CHANGE AFib trial will cover and formally outlines each parties understanding and responsibilities for conducting the trial.
- Trial sites will also be required to enroll and have access to AHA’s Get With The Guidelines on the registry platform so to access the trial database, GWTG-AFib. Sites already participating in GWTG-AFib do not need to sign up for anything additional. Sites that do not participate in any of the GWTG modules will be required to sign the GWTG contract, Unified Participation Agreement (UPA), as a part of site contracting. Sites enrolled in other GWTG modules, other than AFib, will sign an amendment to their existing UPA.
- A Participating Site is required to sign both the UPA and the Site Agreement in order to participate in the CHANGE AFib trial.