Clinical Trial Significant Safety Issue and Urgent Safety Measure Reporting Form in Australia

1. Purpose of the Form

The Clinical Trial Significant Safety Issue/Urgent Safety Measure Safety Reporting Form (SSI/USM form) is designed for sponsors to notify the Therapeutic Goods Administration (TGA) of significant safety issues or urgent safety measures arising during clinical trials conducted under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes. Prompt reporting helps the TGA assess risks and take necessary regulatory actions to protect trial participants. Source: https://www.tga.gov.au/resources/resources/forms/clinical-trial-significant-safety-issueurgent-safety-measure-safety-reporting-form-ssiusm

2. What Constitutes a Significant Safety Issue (SSI)

An SSI is any safety finding that could materially influence the benefit-risk assessment of the investigational product or the conduct of the trial. Examples include:

• New or increased risk of serious harm
• Unexpected serious adverse events
• Safety concerns requiring immediate action (e.g., protocol amendment, participant withdrawal)
• Urgent safety measures implemented to mitigate risks SSIs must be reported regardless of whether the trial is ongoing or completed. Source: https://www.tga.gov.au/resources/resources/forms/clinical-trial-significant-safety-issueurgent-safety-measure-safety-reporting-form-ssiusm

3. Urgent Safety Measures (USM)

A USM is an immediate action taken by the sponsor to protect participants from immediate hazard, such as:

• Temporary or permanent trial suspension
• Urgent protocol changes
• Immediate participant notifications or treatments USMs must be reported to the TGA as soon as possible, typically within 72 hours of implementation. Source: https://www.tga.gov.au/resources/resources/forms/clinical-trial-significant-safety-issueurgent-safety-measure-safety-reporting-form-ssiusm

4. Reporting Timeline and Process

• SSIs: Report within 72 hours of awareness (or sooner if urgent).
• USMs: Notify the TGA immediately upon implementation. The form should be completed electronically and submitted via email to the TGA's clinical trials mailbox. Supporting documents (e.g., investigator letters, amended protocols) should be attached. Source: https://www.tga.gov.au/resources/resources/forms/clinical-trial-significant-safety-issueurgent-safety-measure-safety-reporting-form-ssiusm

5. Information Required in the Form

The form collects:

• Sponsor and trial details (protocol number, CTN/CTA reference)
• Description of the SSI/USM and its implications
• Actions taken or proposed
• Impact on trial participants and continuation
• Timeline of events Accurate and complete information is essential for efficient TGA review. Source: https://www.tga.gov.au/resources/resources/forms/clinical-trial-significant-safety-issueurgent-safety-measure-safety-reporting-form-ssiusm

6. Related Obligations

Reporting via this form does not replace other required notifications, such as:

• Annual safety reports
• Suspected unexpected serious adverse reaction (SUSAR) reporting
• Notifications to ethics committees and reviewing HRECs Sponsors must ensure compliance with all applicable reporting requirements under the National Statement on Ethical Conduct in Human Research and ICH E6 (GCP). Source: https://www.tga.gov.au/resources/resources/forms/clinical-trial-significant-safety-issueurgent-safety-measure-safety-reporting-form-ssiusm

7. Access and Support

The form is available for download on the TGA website. Sponsors experiencing issues or requiring clarification should contact the TGA Clinical Trials Section. The TGA encourages early consultation for complex safety issues. Source: https://www.tga.gov.au/resources/resources/forms/clinical-trial-significant-safety-issueurgent-safety-measure-safety-reporting-form-ssiusm