Safety submissions
Submissions for safety breaches, deviations, events and reports
Safety Submission Types
What is a serious breach?
A breach of good clinical practice or the protocol that is likely to affect to a significant degree:Â
- the safety or rights of a trial participant
- the reliability and robustness of the data generated in the clinical trial.
Reporting timeline
Within 7 calendar days of confirming a serious breach has occurred and provide follow-up reports when required.
Who to submit to?
The the reviewing Human Research Ethics Committee (HREC).
Instructions for submission
Send the serious breach form and any additional related documentation to Health.CALHNResearchMonitoring@sa.gov.au.
What is a suspected breach?
A report that is judged by the reporter as a possible serious breach but has yet to be formally confirmed as a serious breach by the sponsor.
Reporting timeline
Within 72 hours of becoming aware of the suspected breach.
Who to submit to?
The reviewing HREC.
Instructions for submission
Send the suspected breach form and any additional related documentation to Health.CALHNResearchMonitoring@sa.gov.au.
What is a deviation?
Any breach, divergence or departure from the requirements of good clinical practice or the study protocol.
Reporting timeline
Within 7 calendar days.
Who to submit to?
To the institution where the deviation occurred.
Instructions for submission
Send the research deviation report form and any additional related documentation to Health.CALHNResearchMonitoring@sa.gov.au.
What is a significant safety issue?
A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.
Reporting timeline
Within 15 days of the sponsor instigating or being made aware of the issue.
An SSI implemented as an urgent safety measure, as an amendment or as a temporary halt or early termination of a trial should be reported without undue delay and no later than 72 hours of the measure being taken.
Who to submit to?
The reviewing HREC.
Instructions for submission
Send a notification and any additional related documentation to Health.CALHNResearchMonitoring@sa.gov.au.
What is a suspected unexpected serious adverse reaction?
An adverse reaction that is both serious and unexpected.
Reporting timeline
Within 72 hours of becoming aware of the event.
Who to submit to?
To the institution where the issue occurred.
Instructions for submission
Send a notification and any additional related documentation to Health.CALHNResearchMonitoring@sa.gov.au.
What is an unanticipated serious adverse device effect?
A Serious Adverse Device Effect (SADE) which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report (and/or investigator’s brochure/instructions for use).
Reporting timeline
Within 72 hours of becoming aware of the event.
Who to submit to?
To the institution where the issue occurred.
Instructions for submission
Send a notification and any additional related documentation to Health.CALHNResearchMonitoring@sa.gov.au.
What is a safety reporting?
The executive summary of safety information produced for international regulators, such as a development safety update report (DSUR), may serve as the annual safety report.
Reporting timeline
May be aligned with the reporting cycles of global companies or aligned with the progress report.
Who to submit to?
The reviewing HREC.
Instructions for submission
Send the DSUR, safety report form and any additional related documentation to Health.CALHNResearchMonitoring@sa.gov.au.
This page was last updated April 23 2025.