Reporting

All significant safety issues that adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial must be reported

Hazard

The potential of a substance, activity or process causing harm

Near Miss

Any incidents that happen that could have resulted in somebody being injured or damage to property

Incident

Any unplanned event resulting in or having a potential for injury, ill health, damage, and other loss

Accident

Any unplanned occurrence or incident that causes or contributes to personal injury or damage property

Reporting Form

Report Submission