Quality Assurance Activities

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Quality assurance (QA) activities are those in which the primary purpose is to monitor, evaluate or improve the quality of health care delivered by a health care provider (an individual, a service or an organisation). Terms such as ‘QA’, ‘clinical audit’, ‘quality improvement (QI)’, ‘quality activities’, ‘audit’ and ‘quality studies’ are often used interchangeably to refer to activities that fall under the auspice of QA review (NHMRC, 2014).

The GV Health Research and Ethics Unit aims to encourage and facilitate the process of QA activities, as it is an essential process for improving health services and patient outcomes. QA aims to gain information on specific services to create better outcomes and more effective processes.

The applicant should have a clear QA question/topic. For assistance in identifying a relevant question/topic discuss with Clinical Supervisors and/or the Director of Research/Research and Ethics Unit.

Determining QA Eligibility

To determine the level of risk associated with the project, please complete the Risk Assessment Checklist. This will indicate whether the project is eligible for review as a QA activity. The Risk Assessment Checklist must be uploaded as a supporting document for the QA Application Form.

QA activities must be initiated by a GV Health Principal Investigator. Any applications initiated by an external Principal Investigator are not considered QA.

Submitting a QA Application

All QA applications must be submitted by Ethical Review Manager (ERM). For more information on how to submit a QA application via ERM, download the ERM Applicant User Guide.

To create a QA application in ERM, click on the ‘create project’ tile and select the ‘Quality Assurance (QA) VIC’ form.

Your submission must include the following documents:

Risk Assessment Checklist	The Risk Assessment Checklist indicates whether the project is eligible for review as a QA activity.
Project Protocol	The QA application must include a project plan/protocol which must contain: Background and rationale Aims and objectives Methodology for collection of data and who will be collecting the data Consent/Recruitment details Privacy, storage and disposal of data Data source, use, and statistical analysis Risks and ethical issues (including mitigation and management and data governance arrangements) Dissemination plans of the research (e.g. publication) Researchers may elect to use the LNR-Audit Protocol Template.
Curriculum Vitae	A CV for all investigators and members of research team.
Data Request Form	For applications which require access to health records, a Data Request Form must be completed and uploaded as a supporting document to the QA Project Application Form.

The Head of Department and the applicant must sign the QA application Form prior to submission.

Applications must be complete at the time of submission. Incomplete applications will not be accepted and will be returned without being reviewed.

Following submission of a complete QA application, the Human research Ethics Committee (HREC) Subcommittee will review the application. There are no closing dates for QA applications, they can be submitted for review at any time.

If the application is approved by the HREC Subcommittee, the applicant must show a copy of the approval letter and the approved data request form to the Health Information Systems Department for required data or data access.

The investigator must submit a Final Report to the HREC Subcommittee after completion of the QA activity and within the given time frame outlined in the approval letter. The Final Report should be submitted by ERM correspondence.

*All QA investigators must handover QA related data and paperwork to their respective department before they conclude their tenure at GV Health, irrespective of whether the project is complete or not.