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Safety Monitoring and Reporting

Guidelines to Safety Monitoring and Reporting

Safety Reporting – Austin Health Committee providing Ethical Review

Austin Health has implemented guidelines for monitoring & reporting safety which comply with the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016), NHMRC National Statement on Ethical Conduct in Human Research (2007), the Australian Therapeutic Goods Administration, and the Victorian Managed Insurance Authority, maintaining and reporting of adverse events and safety information in clinical research.

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. It is essential that all Principal Investigators are familiar with and comply with the requirements of the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 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.

 

Reporting time frames

Reporting time frames are defined in the Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (NHMRC, 2016).

Researchers should also comply with Austin Health policy and procedures for reporting adverse events described in: 

SOP009 Safety Reporting

 

NHMRC safety reporting flowcharts

 

Safety Reporting - Governance Review via ERM:

 

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.

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.

Notifications should be submitted with completed Safety Report via ERM and  emailed to  EthicsSafetyReports@austin.org.au using this email template.

 

 

 

Austin Health researchers and clinicians reporting to Austin Health via ERM:

Investigators should report the following safety information only for participants at AH sites to the Ethics and Research Governance Unit:

  1. All Significant Safety Issues (SSIs) reported as Urgent Safety Measures (USMs), as amendments or as a temporary halt/early termination of a trial; and
  2. SUSARs/USADEs that are considered possibly related, probably related or definitely related to study conduct.
How to report SSIs and SUSARs/USADEs to AH
  • Complete Safety Report Form via ERM signed by the principal investigator.
  • Click here to open the email templateEthicsSafetyReports@austin.org.au
  • Enter all information requested in the email template.
  • For SUSARs/USADEs ONLY- Also include the patient details and provide any supporting documents in the email. This will enable the Ethics and Research Governance Unit to report the events accurately to the insurers, VMIA.
  • Ensure that you name the subject of the email so that it includes the project number, the type of document and the date it was sent (such as 2018.001 SUSAR 1 Jan 2018).
Acknowledgement
  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Ethics and Research Governance Unit staff in due course.

Investigator reporting to the sponsor

What to Report:

Investigators should report the following safety information to the Sponsor as per the Sponsor's protocols:

  1. SAEs as defined in the protocol;
  2. Any occurrences of congenital abnormality/birth defect arising from any pregnancy of a participant (or partner);
  3. USMs instigated by the site, and;
  4. Safety critical events as defined in the protocol.
Acknowledgement
  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Ethics and Research Governance Unit staff in due course.

Sponsor reporting to the Austin Health HREC via ERM:

What to Report:

Sponsors should report the following trial safety information to the HREC via ERM:

  1. Significant Safety Issues (SSIs) reported as Urgent safety Measures (USMs), as amendments or as a temporary halt/early termination of a trial;
  2. Annual Safety Reports (refer to Annual Safety Report section below) , and:
  3. Investigator Brochure updates and interim addenda (submitted as an amendment via ERM).
How to report SSIs to the AH HREC:
  • All SSIs, annual safety reports, IB updates and interim agenda must be submitted by the Sponsor or delegate via ERM.
  • Enter all information requested in the email template.
  • Attach Safety Report Form via ERM signed by the principal investigator.
  • Click here to open the email templateEthicsSafetyReports@austin.org.au
  • CC the CPI of the trial.
  • Ensure that you name the subject of the email so that it includes the project number, the type of document and the date it was sent (such as 2018.001 SUSAR 1 Jan 2018).
Acknowledgement
  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Ethics and Research Governance Unit staff in due course.

Sponsor reporting to site investigator

What to Report:

Sponsors should report the following trial safety information to the Site Investigator:

  1. Significant Safety Issues (SSIs) reported as Urgent safety Measures (USMs), as amendments or as a temporary halt/early termination of a trial;
  2. All SSIs that adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial;
  3. Investigator Brochure updates and interim addenda, and;
  4. SUSAR/line listings (only if required by the sponsor’s global SOPs).

Note: AH investigators are not required to review safety report from other sites.

Acknowledgement
  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Ethics and Research Governance Unit staff in due course.

Sponsor* reporting to the Therapeutic Goods Administration (TGA)

*Important Note: Where AH is the trial sponsor, the AH Principal Investigator is responsible for reporting to the TGA

What to Report:
  1. All SUSARs occurring in Australian participants,
  2. All SSIs that adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.
Acknowledgement
  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Ethics and Research Governance Unit staff in due course.

Annual safety report

Austin Health has adopted the NHMRC's Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods(2016) guideline.

This updated version has removed the requirement to submit individual reports of AEs, SAEs, external SUSARs/USADEs and six monthly line listings to institutions. Please refer to the information relating to line listings in the summary on page 3 and 'Note 1' on page 7.

Austin Health requires the sponsor to provide HRECs with an annual safety report.

How to submit an annual safety report:

1.    Complete and Submit the Annual Safety Report Form via ERM

2.    Click here to open the email templateEthicsSafetyReports@austin.org.au

3.    Enter all information requested in the email template

4.    Name the file and the subject of the email so that it includes: 

  •  the project number and/or HREC Reference number,
  •  the type of document; and
  •  the date it was sent


Example: 2017.111 HREC/18/AH/111 Safety Report 1 Jan 2017

Acknowledgement

  • An automatic email reply will be sent to you to confirm receipt of the correspondence.
  • Any queries and the acknowledgement letter will be emailed to you by the Ethics and Research Governance Unit staff in due course.

How to Submit a Safety Report via ERM:

  1.     Complete and Submit the Annual Safety Report Form via ERM

    2.    Click here to open the email templateEthicsSafetyReports@austin.org.au

    3.    Enter all information requested in the email template

    4.    Name the file and the subject of the email so that it includes: 

    •  the project number and/or HREC Reference number,
    •  the type of document; and
    •  the date it was sent

Example: 2017.111 HREC/18/AH/111 Safety Report 1 Jan 2017

Please submit 1 electronic copy ONLY with digital signature or wet ink scanned signature to EthicsSafetyReports@austin.org.au using this email template. 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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