Frequency and plans for auditing trial conduct {23}
ADVERSE EVENT
Trial audit, including audit of all enrolled participant data, will be performed by a dedicated auditing team designated by the study’s sponsor and independent from the study steering committee, investigators, and sponsor.Trial audit will consist of verifying participants’ consent procedures and signed consent forms, verifying inclusion and exclusion criteria of enrolled participants, controlling the data collection of the primary outcome measure, controlling adverse event reporting, and reporting any major violation of study procedures. The auditing team will have full access to all required documents, including electronic medical records, in participating centers. Audit visits on the trial site will be performed per batch of 2 to 4 enrolled participants.