Clinical audits, quality assurance and minimal risk research

Lower-risk activities don’t need to go through a full ethics review process. Find out if your proposed activity may be eligible for a fast-tracked submission pathway.

Minimal risk research

The NHMRC National Statement on Ethical Conduct in Human Research (2025) (Chapter 2.1) defines minimal risk as: 

no risk of harm or discomfort; potential for minor burden or inconvenience 
neither burden nor inconvenience should be considered a type of harm or discomfort and therefore should not be viewed as a risk.

 Examples of minimal risk research include: 

use of existing de-identified clinical data with no foreseeable risk to the participants 
use of existing research data for which consent has been provided for the secondary use 
project using surveys or basic short interviews, filling in a form, participating in a street survey, or giving up time to participate in research.

Examples of burden and inconvenience may include: 

filling in forms 
the time required to participate in the research 
costs related to travel.

Please note: If there’s any chance that your project’s risks could increase from being a minor inconvenience to causing discomfort (even if it’s unlikely), you should submit the project through the Lower Risk Research pathway. This ensures the project receives a higher level of review.  

For example, your survey or questionnaire might include questions that make participants feel anxious or emotionally uncomfortable.  

Quality assurance, clinical audit and evaluation activity 

The NHMRC: Ethical Considerations in Quality Assurance and Evaluation Activities (2014) states that the primary purpose of these studies “is to monitor or improve the quality of service delivered by an individual or an organisation”.  

Audits form part of standard hospital monitoring processes and are not considered research.  

The term ‘evaluation’ usually refers to the collection and analysis of information to assess the effectiveness, efficiency and appropriateness of an activity.  

Examples of evaluation activities include:  

clinical audits 
quality improvement activity 
health service delivery evaluation.

An activity whose main goal is to monitor or improve how well a service is working is called a quality assurance (QA) activity.

People often use other terms like ‘peer review’, ‘quality improvement’ or ‘quality studies’ to mean similar things. In this guide, we use ‘quality assurance’.

Please note: It’s important with any of these activities to consider whether the people involved – participants, staff or members of the community – could be exposed to any risk, burden, inconvenience or possible privacy breach.

Determining your ethics review pathway

Before you submit your project, make sure it doesn’t include anything that could increase the level of risk to participants. If it does, the project may need a higher level of ethical review.

You can use this Level of Risk Checklist to help decide if your project qualifies for the faster QA/MRR submission process.

If your project doesn’t meet the criteria for the QA/MRR submission pathway, you must submit a standard research ethics application.

To find out which ethics review process is right for you, visit our Ethics Review Pathways page.

If you’re unsure, you can contact the Office for Research for advice on the correct submission pathway.

Protocol templates

Western Health has specific protocol templates you must use when submitting a project through the QA/MRR pathway. These templates are designed to include all the information the Office for Research needs to review your application.

Before you begin, make sure you know what type of project you’re doing. Then choose the most appropriate Western Health protocol template for that type of activity. Access the two templates below to determine which is right for your project.

Download the Clinical Audit protocol template.
Download the QA MRR protocol template.

Once you’ve determined that your project is eligible for the QA/MRR submission pathway, you can begin your application through the Ethical Review Manager (ERM) Portal.

Fast-tracked (Office for Research) review pathway

This pathway has been developed to fast-track approval for minimal risk research, clinical audits, quality assurance and evaluation activities as described earlier.

This means your activity meets the criteria to be exempt from a full ethics review. The QA/MRR application pathway facilitates an expedited review and approval process by the Office for Research.

The Office for Research will review the application against the tenets of the NHMRC: Ethical Considerations in Quality Assurance and Evaluation Activities (2014) and the NHMRC National Statement on Ethical Conduct in Human Research (2025 and updates) to identify any ethical issues and provide approval only when all issues (if any) have been satisfactorily addressed. 

The Principal Investigator will be issued a letter of approval via email identifying the nature of the project – be it minimal risk research, quality assurance, an evaluation activity or clinical audit.

Projects submitted via this pathway cannot be amended once approved. Exceptions are made, however, for minor administrative changes such as:

changes to personnel
revision to database fields
typographical edits.

The Office for Research will accept, process and acknowledge these on a case-by-case basis. Protocol amendments must be submitted as a new application unless they are associated with any of the outlined acceptable changes.

All projects approved via the QA/MRR pathway must be completed within 2 years. If your project is intended to take longer than this, it should be submitted via an alternate pathway.

Please see our Ethics Review Pathway page for information. At the completion of the project, a final report and self-audit form must be submitted to the Office for Research.

Application support

If you would like advice regarding the process for submission of a QA/MRR applications, or would like guidance to complete the documents, please contact Kerrie Russell at the Office for Research on (03) 8395 8074 or email to [email protected].

It is best that you contact the Office for Research before you submit if you are not sure of the process or are new to Research and QA submissions.

Please ensure you are familiar with Western Health’s Research Code of Conduct (2023) and the WH Standard Operating Procedures – Good Clinical Practice for research. The Office for Research may conduct an audit at any time.

Submission process

For detailed information on the submission process, refer to this submission process map.

The VIC QA application form is for single-site projects in Victoria only. If the same project is being done at multiple sites, you must submit the form to each participating site.

If your project is a multisite QA/MRR activity that has been approved by a certified Human Research Ethics Committee (HREC), and Western Health is one of the participating sites, then you must submit a Research Governance application to Western Health’s Office for Research.

Do not submit a new QA/MRR application via ERM. Please contact the Office for Research for further information on the governance submission process for QA/MRR. More information can be found here.

How to successfully submit your application

Step 1. Request your QA Local Reference Number

Before starting your application, email [email protected] and include:

project title
Principal Investigator’s name
contact person’s name, email and phone number.

For the subject line of the email, write ‘QA reference number request’.

Once issued, the QA reference number must:

be added to the ERM QA Application Form under “Insert local reference number if known”
be included in the footer of all project documents.

Step 2. Follow the mandatory document naming convention

All files must be named correctly before submission. Incorrectly named files will be sent back for correction and delay your review.

Use this format:

[QA Reference/ERM Project ID] [Document Name] [version number] [Date DDMMMYY]

Examples:

QA2024.123_41234 QA PICF_v1_01Jan24.
QA2024.123_41234 Protocol v1 01Jan24.
QA2024.123_41234 Data Collection Sheet v1 01Dec18.

For CVs GCP & Codes (where applicable):

[first name] [last name] WH CV DDMMYY
[first name] [last name] GCP DDMMYY
[first name] [last name] WH Code DDMMYY

Example:

John Smith WH CV_01Jan24; John Smith GCP_01Jan24

Important:

Do not use the upload date as the document date. Use the actual version date shown inside the document.

Step 3. Write your protocol

Choose the correct Western Health (WH) protocol template:

Option A: WH Clinical Audit protocol template
Option B: WH Minimal Risk/QA/Evaluation protocol template

Do not submit the QA/MRR level of risk checklist – this is a guide only.

Privacy and data management

We are all responsible for protecting private personal information at Western Health. We strongly recommend you:

complete a Privacy Impact Assessment (PIA) during project planning
follow the Privacy & Data Protection Act 2014.

Please see the Office of the Victorian Information Commission (OVIC) website for the PIA and guidelines.

Please note that this form does not need to be submitted to the Office for Research. For guidance and review of data management plans, contact Western Health’s Corporate Records Management through [email protected].

Please also note that if your project is audited, this document (the PIA) may be requested for review as a supporting document.

Step 4: Complete the QA VIC Form on ERM

Log into the ERM Portal.
Upload all required documents.
Request electronic signatures from:
- all named investigators
- Head of Department
- any other supporting department heads

All investigators or named department heads must have an ERM account. Check the HELP section on the ERM website for signature guidance. For more guidance and tools, see the Victorian Government’s Clinical Trials and Research website.

Step 5: Submit CVs for all investigators

For this step, you can either:

use the WH CV template (signed and current within 2 years), or
submit a full signed CV and a signed WH Research Code of Conduct (2023).

Step 6: Submit GCP training certificates

All investigators (including students) must complete GCP training.
Training is valid for 3 years.
For more information, visit our GCP training webpage.

Step 7: Submit a database template

If collecting data (prospectively or retrospectively), provide a PDF version of the database template.
From 1 July 2020, all QA/MRR data must be stored on WH REDCap.
- You can export a PDF of the data fields from REDCap once set up.

Step 8: Include any other required documents (if applicable)

Submit the following only if your project includes them:

Participant Information Consent Forms (PICF) – use the WH QA PICF Template
information letters or invitations
surveys or interview guides
advertising materials (e.g. posters, website text)
master re-identifier spreadsheet field headers, e.g. UR number, Study ID, Date of Admission)
Research Agreement (if involving external parties).

For more information, visit our Research Agreements page.

Step 9: Pay the application fee

QA and MRR projects have a review fee.
Make sure you upload:
- a completed GST-compliant tax invoice
- payment receipt (credit card or EFT).

For more information, visit our fee schedule page.

Final checks before you submit

Make sure:

all required documents are uploaded
documents follow the correct naming format
all required signatures have been collected on ERM.

Note: Requesting signatures does not submit the application. You must wait until all signatures are complete, then manually submit.

What happens next

Once you’ve submitted your application via the ERM Portal, here’s what you can expect.

Initial review

The Office for Research will review your application within 5 business days.
You’ll receive an email from ERM letting you know if anything more is needed.
If more details or corrections are required, the application status in ERM will show: “Information Requested”.

Second review (if no issues)

If no further information is needed after the initial review, a second reviewer from the Office for Research will review your application.
The status will update to: “Assigned to Reviewer”.

Outcome

If everything is in order, your application will be approved.
- Status changes to “APPROVED”.
- You’ll receive a formal approval letter via ERM.
If more information or clarification is needed:
- A Request for Information letter will be emailed to you.
- ERM status will return to “Information Requested”.

Please note:

To avoid delays, please respond promptly to any requests for information. You’ll have 2 weeks to respond, and you’ll only receive one reminder if no response is received.
Your application may be withdrawn if:
- no response is received by the deadline
- you don’t contact the Office for Research to explain the delay or request an extension.
If there’s no communication for over one month, your application will be automatically withdrawn.
- If this happens and you still wish to proceed, you must submit a new application and pay another application fee.

Post-approval requirements

Once your project is approved, there are a few important things to keep in mind.

Making changes after approval

Only minor administrative changes can be made, such as:
- adding or removing project personnel
- updating database fields
- fixing typos in documents.
On a case-by-case basis, these changes are accepted and processed by the Office for Research.

Post Approval Forms you’ll need (available in the Forms Library)

WH QA Change of Personnel Form
WH QA Amendment Form

To submit a change:

Complete the relevant post approval form
Open your application in ERM.
Select the Correspond action tab.
Write a short explanation of the change in the auto-generated email.
Upload the relevant QA/MRR form (selected from the forms library).
Upload any additional documents that support the change, e.g. CV, GCP certificate, database template.
You’ll receive an email acknowledgment from the Office for Research once your request has been received and processed.