Pro-forma checklist to assist with preparing an ethics application (MS Word Document - 164.4 KB)

To assist with preparing a research governance / Site Specific Assessment (SSA) application (MS Word Document - 772.1 KB)

For each research project that has a site in Victoria, the Victorian Specific Module (VSM) must be completed and submitted to the reviewing Human Research Ethics Committee (HREC) as part of the ethics application. (MS Word Document - 69.2 KB)

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If using the Participant Information Consent Form for non-interventional coronavirus research, it will be necessary for other jurisdictions to insert specific legislation if applicable. (MS Word Document - 102.9 KB)

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This paper provides guiding principles to optimise digital technology for executing CTRAs using eSignatures. (PDF File - 236.3 KB)

This document provides background information and guidance for a scientific expert reviewer to conduct scientific review, at the request of an ethics committee in Victoria, regarding early phase clinical trials. (PDF File - 2.5 MB)

This document provides details and contact information for organisations taking part in the National Mutual Acceptance (NMA) initiative. (PDF File - 477.5 KB)

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This document aims to provide an overview of the various legislative and administrative frameworks that currently exist in Commonwealth, States and Territories and apply to the approval of human research under Mutual Acceptance of Ethics and Scientific Review. This document is not a substitute for legal advice. (PDF File - 334.6 KB)

This matrix is designed to assist investigators, HREC Coordinators and Research Governance Officers. It provides information on reporting requirements for multi-centre human research projects taking place in Australia. (MS Excel Document - 437.9 KB)

Arrangements for ethics and research governance/Site Specific Assessment (SSA) applications across the NMA jurisdictions are described in this NMA Ethics and Governance Matrix table. (PDF File - 187.8 KB)

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The National Mutual Acceptance (NMA) scheme has been revised to better support researchers undertaking multi-jurisdiction studies involving linkage of data. (MS Word Document - 156.1 KB)

Additional supporting documents that address state legislation e.g. Western Australian Specific Module (WASM) and Victorian Specific Module (VSM) may be required for some research projects. (MS Word Document - 140.2 KB)

Dealing with requested amendments to the Participant Information Consent Form (PICF) following implementation of the European Union’s General Data Protection Regulation (GDPR). (MS Word Document - 118.8 KB)

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The purpose of this document is to provide guidance to assist all sectors involved in clinical trials to understand the processes used to meet the regulatory requirements for clinical trial research in Australia. (PDF File - 1.1 MB)

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These guidelines provide useful information and specific instructions for completing Sections 1, 2 and 3 of the Victorian Specific Module. (PDF File - 351.8 KB)

For each research project that utilises the Human Research Ethics Application (HREA) form and has a site in Victoria, the Victorian Specific Module (VSM) must be completed and submitted to the reviewing Human Research Ethics Committee (HREC) as part of the ethics application. (PDF File - 424.7 KB)

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For an Investigator Initiated Study (MS Word Document - 53.2 KB)

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Template letter to use if Ionising radiation exposure in a research project is not considered to be additional to normal clinical management/care at the site and the reviewing HREC is in Victoria (MS Word Document - 21.0 KB)

In the event that a participant in an approved interventional clinical trial (or the participant’s partner) becomes pregnant during the course of the research, this Participant Information Sheet/Consent Form should be provided to the pregnant participant/partner. (MS Word Document - 62.0 KB)

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A Participant Information sheet should be aimed at parents/guardians when the potential participant is a child. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 4.2) for more information. Consideration should also be given to explaining the procedure to the child themselves in a manner appropriate to their maturity level. (MS Word Document - 175.6 KB)

A Participant Information sheet should be aimed at persons responsible/medical treatment decision makers when the potential participant does not have decision making capacity or not competent to provide consent for themselves. Refer to The National Statement on Ethical Conduct in Human Research (Chapters 4.4 & 4.5) for more information. This Participant Information Sheet/Consent Form should not be used for parents/guardians of minors; an alternative template is available for parents/guardians. (MS Word Document - 175.0 KB)

Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research. (MS Word Document - 229.1 KB)

Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research. (MS Word Document - 228.4 KB)

Use this PICF for genetic research that is non-interventional OR genetic research that has an interventional component that does not involve research on a drug or device. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 3.5) for information on genetic research. (MS Word Document - 221.8 KB)

An Interventional Study is defined as administration of a drug, device or procedure that is not part of routine care, including all phases of a clinical trial. (MS Word Document - 228.4 KB)

A Participant Information sheet should be aimed at persons responsible when the potential participant does not have decision making capacity or not competent to provide consent for themselves. Refer to The National Statement on Ethical Conduct in Human Research (Chapters 4.4 & 4.5) for more information. This Participant Information Sheet/Consent Form should not be used for parents/guardians of minors; an alternative template is available for parents/guardians. (MS Word Document - 233.7 KB)

Adult providing own content. An Interventional Study is defined as administration of a drug, device or procedure that is not part of routine care, including all phases of a clinical trial. (MS Word Document - 222.3 KB)

A Participant Information sheet should be aimed at parents/guardians when the potential participant is a child. Refer to The National Statement on Ethical Conduct in Human Research (Chapter 4.2) for more information. Consideration should also be given to explaining the procedure to the child themselves in a manner appropriate to their maturity level. (MS Word Document - 194.8 KB)

A Participant Information sheet should be aimed at persons responsible/medical treatment decision makers when the potential participant does not have decision making capacity or not competent to provide consent for themselves. (MS Word Document - 193.0 KB)

Adult providing own consent. A Non-Interventional research project involves clinical research where no interventional treatment is given to participants other than their routine care. It does not involve the administration of an investigational product, treatment or procedure. Examples include observational research and monitoring of participants. (MS Word Document - 189.5 KB)

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The Stand Alone Teletrial PICF is used for an approved trial when a teletrial will be added to the existing trial, instead of amending a Master PICF.  This is used for the added Satellite Site(s). (MS Word Document - 48.0 KB)

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