Safety reporting

Safety Reporting - Peter Mac Ethics Committee providing Ethical Review

The requirements for Safety Reporting to the Peter Mac Human Research Ethics Committee (HREC) are described in SOP006 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 Peter Mac HREC to comply with the reporting requirements in Safety Monitoring and Reporting in Clinical Trials NHMRC Nov 2016. When communicating safety information to the Peter Mac HREC the Sponsor or their delegate must clarify the impact of each report on patient safety, trial conduct and trial documentation.

The Peter Mac 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.

Safety Items required to be submitted will be acknowledged.

Email safety notifications to [email protected] per the following table:

REPORTING PARTY

REPORT REQUIRED AND TIMELINESUPPORTING 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 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 SOP004

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

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Safety Reporting - Governance Review

The requirements for Safety Reporting to the Peter MacCallum Cancer Centre Research Governance Officer are described in Guideline001 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 Peter MacCallum Cancer Centre Research Governance Officer, the Principal Investigator or their delegate must clarify the impact of each report on patient safety, trial conduct and trial documentation. 

Peter MacCallum Cancer Centre 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 Peter Mac site.

Safety Items required to be submitted will be acknowledged.

Email safety notifications to [email protected] per the following table:

REPORTING PARTYREPORT REQUIRED AND TIMELINESUPPORTING INFORMATION REQUIRED
Principal Investigator or delegate

Notify the Peter Mac Research Governance Officer of all Significant Safety Issues that occur at the Peter Mac 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 Peter Mac site and meet the definition of an Urgent Safety Measure should be notified within 72 hours.

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

II. All other Significant Safety Issues that occur at the Peter Mac site should be notified within 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 Peter Mac RGO without undue delay.

III. Submit amendment per Peter Mac Guideline001

IV. Temporary halt of trial for safety reasons that occur at the Peter Mac 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 Peter Mac site should be notified without undue delay and within 72 hours of the  decision to terminate the trialV. Reasons for the early termination; measures taken; further actions planned
Principal Investigator or delegateNotify the Peter Mac Research Governance Officer of all SUSARs/USADEs that occur at the Peter Mac site within 72 hours

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