This section applies to both high and negligible/low risk research projects which have received ethical approval. It is the responsibility of the principal investigators to ensure that they comply with the requirements of both ethical and research governance conditions of approval.

In instances where there is a discrepancy in requirements, the Northern Health Office of Research will be guided by the approving HREC.

The approving HREC may require that reports are completed on their accepted templates.

Progress & Final Reports

It is the responsibility of the researcher to submit an annual report as per ethical/research governance approval letters. An annual progress report must be submitted for the duration of the project.  This report is due on the anniversary of HREC approval. Continuation of research governance approval is contingent on submission of an annual report, due within one month of the approval anniversary. Failure to comply with this requirement may result in suspension of the project by the Northern Health Office of Research & Ethics.

For multi-site research project, a Northern Health annual site report should be submitted annually.  HREC acknowledgment for the NH annual report is not required unless requested by the HREC. A copy of the HREC Progress Report – CPI Cover Sheet is not required.

Progress and final report forms (scroll to bottom of linked page)

Amendments

An amendment must be submitted when there is any change to the current approved project, eg: change in research team, extension of ethical approval, change in protocol, update to safety or any document approved by an ethics committee.

Amendments should be submitted after ethics approval is obtained from the reviewing HREC. The amendment should be submitted with a copy of the associated documents and approval letter from the reviewing HREC. Amendments are not to be implemented until acknowledgment is received from the Northern Health Office of Research & Ethics.

Amendment forms (scroll to bottom of linked page)

Governance fees – Amendments 

Protocol Deviation and Violation

A protocol violation is a failure to comply with the study protocol as approved by the Ethics Committee. A violation is a serious non-compliance with the protocol that can affect participant safety & integrity of the study.

Submit to the approving HREC AND lodge a Riskman if there was a real or potential increase in risk to NH participants’ safety

Concurrent submission to the HREC and the research governance office should occur if the protocol impacts on the overall conduct of the trial or the patients enrolled at Northern Health. Forward to the Northern Health Office of Research & Ethics the HREC acknowledgment/response when received. Otherwise submit to RGO with notification from the HREC.

Protocol Violations should be submitted using the Serious Breach Form via ERM. Please outline in the report why the violation occurred and what steps have been taken to rectify the violations.

Please also submit one electronic copy with signatures to ethics@nh.org.au.

A protocol deviation is a less serious non-compliance with the approved study protocol and generally does not impact on participant safety.

To report to the NH Governance Officer, the Non serious Breach – Deviation Report should be completed and emailed ethics@nh.org.au

Please also submit the form via ERM.

Major deviations that impact on patient safety should be submitted using the Serious Breach Report Form via emial and ERM. Please outline in the report why the deviation occurred and what steps have been taken to rectify the violations.

In the event that a serious breach has occurred and the sponsor of the research does not agree or is unwilling to report the breach to the Ethics Committee, a Suspected Breach Report Form (thrid party) can be completed. The report form should be sent to the reviewing HREC.

Serious Breach Form, Non serious Breach – Deviation Report & Suspected Breach Report Form (thrid party) can be found on Health Vic website. (scroll to bottom of linked page)

Safety and Adverse Event Reporting

Northern 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.)

The Therapeutic Goods Administration definition of a serious adverse event is:

Any untoward medical occurrence that at any dose:

  • Results in death,
  • Is life-threatening, (NOTE: The term “life-threatening” in the definition of “serious” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/reaction which hypothetically might have caused death if it were more severe)
  • Requires inpatient hospitalisation or prolongation of existing hospitalisation,
  • Results in persistent or significant disability/incapacity,
  • Is a congenital anomaly/birth defect, or;
  • Is a medically important event or reaction.

For more information on adverse events, click here to download the TGA’s Australian Clinical Trials Handbook or safety monitoring and reporting in clinical trials involving therapeutic goods. 

Serious Adverse Events (SAEs)/Adverse Events (AEs)/ Significant Safety Issues (SSI)

Significant Safety Issue (SSI): A safety issue that could adversely affect the safety of participants or materially impact on the continued ethical acceptability or conduct of the trial.

In accordance to the NHMRC Safety monitoring and reporting clinical trials involving therapeutic goods Nov16 , researchers are only required to forward the SAES/AEs that occurred at Northern Health sites and Northern Health participants that are considered a Significant Safety Issue within 72 hours of the event to ethics@nh.org.au

Researchers to also please provide a HREC Acknowledgment of SAEs/AEs with the HREC Safety Report form to ethics@nh.org.au

Governance review and acknowledgment will be issued via email.

All other SAEs/AEs that are “Related, Probably related, Possibly related or unrelated” are not required to be submitted to the Northern Health Office of Research and Ethics. Sponsor and Investigator are required to keep detail records of all reported adverse events.

Suspected Unsuspected Serious Adverse Reactions (SUSARs)/Unanticipated Serious Adverse Device Effects (USADEs) Reporting

A SUSAR (Suspected Unexpected Serious Adverse Reaction) is an adverse reaction that is both unexpected (not consistent with the applicable product information) and also meets the definition of a Serious Adverse Event/Reaction.
An USADE (Unanticipated Serious Adverse Device Effect) is any serious adverse effect on health or safety, any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

There is no need to submit external SUSARs/USADEs Line listings to the Northern Health Office of Research & Ethics.

SUSARs arising from Northern Health site should be submitted for governance acknowledgement only. No HREC acknowledgement is required.

Governance acknowledgment nt will be issued via email.

RGOs will no longer receive: Single case AEs, SAE/SARs and external SUSARs or device/non-therapeutic good equivalents or six monthly line listings.

RGOs will receive: All significant safety issues (SSIs), annual safety report, any local SUSARs/USADEs/URSAEs and any research-related events that meet the definition of an incident.

Click on the link and scroll to the bottom of the page to download the Safety Report template.

All  Safety Reports must be signed by the Chief Principal Investigator or local Principal Investigator, and submitted electronically to: ethics@nh.org.au and relevant regulatory bodies.

Annual Safety Report

For clinical trials involving an investigational drug or device an Annual Safety Report must be submitted for ethics review to the reviewing Ethics Committee.

For Investigator Initiated Trials this can be submitted with the annual progress report. The report should be attached as an appendix.

For Commercially Sponsored Trials, 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 sent to HRECs (a full DSUR is not required). The timing of the annual safety report may be aligned with the reporting cycles of global companies or aligned with the annual progress report sent to the HREC.

Please refer to the reviewing HREC’s website for more detailed instruction.

NH Governance requirement:

Submit the annual safety report and the HREC acknowledgement to ethics@nh.org.au for NH governance acknowledgement.