Research

Safety Monitoring and Reporting

Guidelines to Safety Monitoring and Reporting

Safety Reporting – Austin Health Committee providing Ethical Review

The requirements for Safety Reporting to the Austin Health Human Research Ethics Committee (HREC) are described in

SOP009 Safety Reporting

Note: for multi-site ethical review projects you will need to check which Ethics Committee provided the ethical approval for the project and submit the report to that reviewing Ethics Committee for ethical review.

It is the responsibility of Sponsors, Contract Research Organisations, Investigators, Institutions and their delegates, of clinical trials involving therapeutic goods that were approved by the Austin Health HREC to comply with the reporting requirements in

Safety Monitoring and Reporting in Clinical Trials NHMRC Nov 2016

When communicating safety information to the Austin Health HREC the Sponsor or their delegate must clarify the impact of each report on patient safety, trial conduct and trial documentation.  The items below required to be submitted to the Austin Health HREC by the Sponsor or delegate will be acknowledged.

The Austin Health HREC will advise the TGA, investigators and their institutions of any decision to withdraw approval, including the reason for the withdrawal of approval and date of the withdrawal of approval.

Notifications should be emailed to by completing a Safety Report and emailing to EthicsSafetyReports@austin.org.au  per the advice in the following table.

 

REPORTING PARTY

REPORT REQUIRED AND TIMELINE

SUPPORTING INFORMATION REQUIRED

SPONSOR or delegate

Provide the HREC with annual update of the Investigator’s Brochure or where applicable, Product Information.

Provide the HREC with any Addenda to the Investigator’s Brochure or where applicable, Product Information.

 

SPONSOR or delegate

Provide the HREC with an Annual Safety Report including a clear summary of the evolving safety profile of a trial.

NOTE: The HREC has the discretion to request more frequent reporting for specific trials, such as early phase trials.  Such a request may be stated on the initial Ethical Approval for a trial or may be instituted during the conduct of the trial.

A brief description and analysis of new and relevant findings;

For IMPs not on the Australian Register of Therapeutic Goods, a brief analysis of the safety profile of the IMP and implications for participants taking into account all available safety data and results of relevant clinical or non-clinical studies

A brief discussion of the implications of the safety data to the trials risk-benefit ratio

A description of any measures taken or proposed to minimise risks

SPONSOR or delegate

Notify the HREC of all Significant Safety Issues that adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.

 

I. Significant Safety Issues that meet the definition of an Urgent Safety Measure should be notified within 24-72 hours.

I. Reason for the urgent safety measure; measures taken; further actions planned

II. All other Significant Safety Issues should be notified within 15 calendar days of the sponsor instigating or being made aware of the issue.

II. Details of the significant safety issue; further actions planned

III. Significant Safety Issues often result in safety-related changes to trial documentation. Any resulting amendment should be submitted to the HREC without undue delay.

III. Submit amendment per Ethics Committee guidelines

IV. Temporary halt of trial for safety reasons should be notified within 15 calendar days of the sponsor’s decision to halt the trial.

IV. Reasons for the halt; the scope of the halt (e.g. suspension of recruitment or cessation/interruption of trial treatment); measures taken; further actions planned.

V. Early termination of a trial for safety reasons should be notified without undue delay and within 15 calendar days of the sponsor’s decision to terminate the trial

V. Reasons for the early termination; measures taken; further actions planned

 

Safety Reporting - Governance Review

It is the responsibility of Sponsors, Contract Research Organisations, Investigators, Institutions and their delegates, of clinical trials involving therapeutic goods to also comply with the reporting requirements in NHMRC Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods November 2016.

When communicating safety information to the Austin Health Governance Officer, the Principal Investigator or their delegate must clarify the impact of each report on patient safety, trial conduct and trial documentation.  The items below required to be submitted to the Austin Health Research Governance Officer by the Principal Investigator or their delegate will be acknowledged.

Austin Health Research Governance Officer will report any concerns regarding sponsor conduct to the reviewing HREC and will notify the Victorian Managed Insurance Authority (VMIA) of any SUSARs/USADEs that occur at the Austin Health site.

Notifications should be emailed to by completing a Safety Report and emailing to EthicsSafetyReports@austin.org.au  per the advice in the following table.

 

REPORTING PARTY

REPORT REQUIRED AND TIMELINE

SUPPORTING INFORMATION REQUIRED

Principal Investigator or delegate

Notify the Austin Health Governance Officer of all Significant Safety Issues that occur at the Austin Health site that adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial:

 

I. Significant Safety Issues that occur at the Austin Health site and meet the definition of an Urgent Safety Measure should be notified within 24 - 72 hours.

I. Reason for the urgent safety measure; measures taken; further actions planned

II. All other Significant Safety Issues that occur at the Austin Health site should be notified within 24-72 hours.

II. Details of the significant safety issue; further actions planned

III. Significant Safety Issues often result in safety-related changes to trial documentation. Any resulting amendment should be submitted to the reviewing HREC and Austin Health RGO without undue delay.

III. Submit amendment per Austin Health amendment guidelines.

IV. Temporary halt of trial for safety reasons that occur at the Austin Health site should be notified within 72 hours of the decision to halt the trial.

IV. Reasons for the halt; the scope of the halt (e.g. suspension of recruitment or cessation/interruption of trial treatment); measures taken; further actions planned.

V. Early termination of a trial for safety reasons that occur at the Austin Health site should be notified without undue delay and within 72 hours of the  decision to terminate the trial

V. Reasons for the early termination; measures taken; further actions planned

Principal Investigator or delegate

Notify the Austin Health Research Governance Officer of all SUSARs/USADEs that occur at the Austin Health site within 24 hours

Details of the event, further actions planned, copy of notification to sponsor

 

 

How to Submit a Safety Report

1. Complete and submit a Report signed by the principal investigator.

Please submit 1 electronic copy ONLY with digital signature or wet ink scanned signature to EthicsSafetyReports@austin.org.au. Electronic signatures will not be accepted.

Please note all supporting electronic documents must be labelled according to the following Naming Requirement for Electronic Files using the approved acronyms and document types

Mail to: EthicsSafetyReports@austin.org.au

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