Quality Assurance Projects (QA)

Read Getting Started before you begin.

An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a QA activity. Terms such as ‘peer review’, ‘quality assurance’, ‘quality improvement’, ‘quality activities’, ‘quality studies’ and ‘audit’ are often used interchangeably. In this document the term ‘quality assurance’ is used to include all of these terms and reflects the name of the corresponding review pathway.

Irrespective of whether an activity is QA, evaluation or research, the activity must be conducted in a way that is ethical. This should include consideration of whether the people involved will be exposed to any harm as a result of the activity. Those conducting the activity need to consider a range of issues including consent, privacy, relevant legislation, national/professional standards.

To be eligible for review as a QA project, the project must meet the following criteria:

• “The data being collected and analysed is coincidental to standard operating procedures with standard equipment and/or protocols;
• The data is being collected and analysed expressly for the purpose of maintaining standards or identifying areas for improvement in the environment from which the data was obtained;
• The data being collected and analysed is not linked to individuals; and
• None of the triggers for consideration of ethical review (listed in point (e) of Ethical Considerations in Quality Assurance and Evaluation Activities NHMRC 2014) are present.”

Projects that do not meet the criteria above require formal ethics review.

Retrospective review/approval of QA Applications is not permitted.

How do I apply for approval?

Applications are submitted via Ethical Review Manager (ERM).  If you do not have an account register here Login – ERM Applications.

All Investigators, Head of Department, Head of Supporting Department(s) must also have an ERM account for electronic signature through ERM.

The Applicant user guide to ERM provides comprehensive guidance on how to use ERM.

What documents do I need to submit?

Below is a list of the documents required for submission. Incomplete applications will not be accepted for review.

All documents must have a version number and date (no draft documents or those with comments or tracked changes will be accepted as part of the initial submission).

Use the QA Checklist to assist with compilation of your application.

How is my project reviewed?

Applications are reviewed weekly by the Manager Office for Research and Director of Research. The outcome of the QA application review will be sent by the Office for Research via ERM. You will receive a notification in your ERM account work area.

Projects at Peninsula Health must not commence until a formal signed approval letter is received from Peninsula Health.

Amendments and Reporting

Any changes to the project which may impinge on the ethical principles that guide human research must be submitted through ERM Correspondence for approval prior to implementation.

A brief final report and any abstracts accepted for publication or external presentation must be submitted via ERM on completion of the project. This will also enable the project to be closed.