Is the expectation that the site Principal Investigator (PI) prescribe dronedarone for the entire 12 months?

NO. The PI OR any other prescribing member of the trial team may prescribe dronedarone.

However, the PI does need to assume responsibility for the patient, their participation, and the following of the protocol. In the case of dronedarone, this will include oversight to ensure subjects are taking the medication as prescribed and educating any other providers that are working with the subject. The PI may delegate this monitoring to another member of the trial team