Post-Authorisation Management

The RGDU is responsible for monitoring the conduct of the research project at the site-level, in order to do this effectively the timely notification of changes to the research must be communicated for the duration of the project. RGDU must be provided with all relevant amendments, notification of HREC approval of amendments, and any information relevant to the conduct of the project.

It is the responsibility of the Principal Investigators to ensure that they comply with the requirements of both ethical (HREC) and governance (RGO) conditions of approval.

The approving HREC of the project may require that reports be completed on their accepted templates, follow their guidance for completion of appropriate documentation and timelines.

In Victoria, all post-authorisation report forms are completed using the Ethical Review Manager (ERM) website (ERM login page). Refer to the Applicant user guide to ERM, navigate to page 91 “Post Authorisation” and follow the instructions to create a sub-form as required or for information on using ERM.

All required documentation should be submitted via ERM, although as submission does not provide a notification to the RDGU, an email is required to be sent to ResearchDGU@nh.org.au along with the following detail:

  • ERM Number (in the subject of the email)
  • Project Title
  • Name of Principal Investigator
  • Detail on what was submitted

Graphic
Figure 1 Vic Gov. Clinical Trials and Research

Amendments

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

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 an acknowledgment is received from the RDGU.

Progress & Final Reports

It is the responsibility of the researcher to submit an annual report as per ethical/research governance authorisation 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 authorisation is contingent on the 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 RDGU.

For a 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.

In addition, a final report should be submitted to the reviewing HREC and RDGU upon completion of the project.

Safety Reporting

The principal investigator has a responsibility to ensure the conduct of the trial, including the monitoring of safety and reporting of adverse outcomes, complies with the study protocol.

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.

Protocol Deviation and Violation

A protocol deviation is a non-compliance with the approved study protocol and generally does not impact on participant safety. To fulfill ICH-GCP requirements any deviations are to be reported to the sponsor, refer to the protocol for more information. However, non-serious deviations do not require reporting to the RDGU.

The sponsor in collaboration with the principal investigator should maintain a non-serious breach line listing log, in the site file. This line listing report should be submitted with the project annual report to the RDGU.

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 (third party) can be completed. The report form should be sent to the reviewing HREC.

A protocol violation is a failure to comply with the study protocol as approved by the Ethics Committee (HREC). 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 RDGU should occur if the protocol impacts on the overall conduct of the trial or the patients enrolled at Northern Health. Forward to the NH RDGU once HREC acknowledgment/response is received, otherwise submit to RDGU with the notification from the HREC.