Quality Assurance (QA) projects are often been referred to as a research activity, however this is not necessarily the case. Rather, QA refers to a suite of processes aimed at ensuring that specific standards are met

To qualify as a QA project, specific criteria must be satisfied. If findings from QA projects are planned for internal Northern Health use only and there is no plan for dissemination of findings outside Northern Health, no formal application to RDGU is required.

If findings from a QA project are planned for dissemination, either via a conference presentation or external publication, a formal QA Proposal Form must be completed and submitted to the RDGU (ResearchDGU@nh.org.au) to obtain a QA project reference number.

If in doubt about future external dissemination plans, we recommend obtaining a QA reference number.

How to apply for QA approval

Initial Submission:

Step 1: Contact RDGU (ResearchDGU@nh.org.au) to discuss the suitability of your project for the QA pathway.

Examples of what is considered a QA project include:

  • An evaluation of data collected as part of routine clinical care or service delivery
  • Retrospective or prospective collection of data already recorded in the medical record to assess the quality or effectiveness of an investigation or intervention against a known standard
  • No prospective recruitment or randomisation of participants
  • No risk to participants or organisation or breach of confidentiality
  • Project restricted to Northern Health
  • Participants records (medical records, databases, data/tissue banks) used for these activities may only be accessed by those with usual access (through routine clinical care or professional practice) or by those with a directly related secondary purpose

Note – Any requirement for either a patient or a staff member to collect new data or undertake any additional non-standard activity means it is not a QA activity.

Step 2: We strongly recommend booking an appointment with the RDGU team to help develop your protocol. This includes booking an appointment with RDGU’s clinical biostatistician, Dr. Mani Suleiman (Biostatistics Service Request Form), to develop your analytical plan.

Step 3: Prepare the following documents:

  1. Complete and signed QA Application Form (found in Library of Resources). Both the Principal Investigator and the Head of Department must sign before we can process your review request.Please note: The Principal Investigator must be either a Northern Health employee or have an honorary appointment with Northern Health.
  2. Any instruments and tools required to carry out your project, e.g. surveys, data collection tools (example here), participant ID linking tools (example here).
  3. Any other attachments that support your project protocol.

Please ensure all documents are clearly named by type, and include a version number and date as part of the document name.

Step 4: Submit all documents in a single email to ResearchDGU@nh.org.au. Please submit only one project per email for review.

Review and Approval Process:

Once all documentation has been checked for completeness, your project will be sent for review. The review panel will assess your application with regard to the four values and principles of the National Statement:

  • Research Merit and Integrity
  • Justice
  • Beneficence
  • Respect

RDGU will endeavour to provide a review outcome within 10 business days of receiving your complete application. Should further information or clarification be required from the investigators in order to fully assess your project, this will be requested following review.

An approval letter will be issued when the project/amended project is cleared to commence. Please note that no activity related to the project can commence until the approval letter has been issued.