Adverse event reporting and harms {22}
ADVERSE EVENTS, ADVERSE EVENT
Serious adverse events associated with the intervention will be reported to the HREC. The CTC, chief investigators, and site associate investigators (AI) are responsible for:Collating safety and adverse event information and submitting annual safety reports to Human Research Ethics Committees (HREC)Reporting expected and unexpected adverse events (AE) to the DSMBReporting to the institution without undue delay and no later than 72 h after becoming aware of all significant safety issues and unanticipated serious adverse device effects (USADEs) occurring at the siteMaintaining detailed, up-to-date records of all adverse device effects (ADEs) and device deficiencies that ResNs reportCommunicating safety information to investigators and/or HRECs, to clarify the impact of each report on patient safety, trial conduct, and/or trial documentationAssessing and categorising information received from investigators and reporting all USADEs occurring in participants to the TGA in accordance with NHMRC guidelines