Quality Assurance (QA) projects are an essential and integral part of health care delivery. The ethical principles of integrity, respect for persons, beneficence and justice as set out in the National Statement on Ethical Conduct in Human Research (2018) also apply to QA.

Staff conducting QA activity must consider a range of issues including consent, privacy, relevant legislation, professional standard, and whether ethical review is required.

Key documents

Applicants should familiarise themselves with the following Acts, Codes or Guidelines:

Is my project quality assurance?

Click here to determine whether your project is considered QA or research.

QA acknowledgement

The OFR will acknowledge the QA project via email and provide you with an application reference number and confirmation of the study period. Retain the approval information in your study records as confirmation that your application has been noted by the OFR.

The study must be complete within 2 years of the date of the acknowledgement email.

Also note:

  • if there are any changes to the project a new QA project will need to be submitted
  • if the study is to continue beyond 2 years, a new QA project will need to be submitted
  • annual progress reports are not required for QA projects

Multi-site QA projects will receive acknowledgement covering ethics and governance review for the RMH site only. Collaborating organisations may choose to accept the RMH review or may require the application to be reviewed under its review process.

Sharing your improvements

To increase opportunities to share improvements across the organisation and avoid duplication of effort QA projects undertaken at The Royal Melbourne Hospital that have received review and acknowledgement from the HREC and Office for Research will be added to the new organisation-wide project register which will be shared via Workplace and the intranet. This will include the title, description and key contact of the project. You may also be contacted by the improvement team to provide an update of your project’s status for the register. If you have any concerns or wish to opt out please contact the improvement team via email at improvement.team@mh.org.au.

The application process

It is the responsibility of the applicant to complete and submit all applicable documentation including obtaining statements of approval from HIS, pathology etc. and Head of Department and Divisional Director approval and declaration form.

The following steps will help you to complete your application for QA.

1. Check that your department will support you in conducting the study

Ask your manager if you can do the study and if there is a departmental process that you need to also comply with in order to get approval to conduct the study.

2. Prepare the study protocol

Prepare a detailed protocol that includes information on all steps and processes that will be conducted for the project.

Researchers may elect to use the QA project protocol template.

Conduct a literature search and ask for advice from your colleagues to ensure that you have a robust protocol.

Include the following information:

  • who has written the protocol
  • who will be involved in the study and in what capacity
  • clear aims
  • clear and complete procedures
  • what information/data will be collected
  • how information will be collected and in what format (include templates of data collection forms/tools in the application)
  • how data will be stored (i.e. on the RMH server)
  • who will have access to the data
  • If any personal identifying data is collected, how will confidentiality be maintained, stored, protected etc.
3. Complete the QA application form

Download and complete the QA Application Form.

Ensure that you complete the Declarations section of the application form. The designation requirements are outlined in the form.

Ensure that all other supporting documents are completed and are ready to be included in the application, such as:

  • clear and detailed protocol (use the QA project protocol template)
  • assessment tools
  • data collection sheets.
4. Complete the Participant Information Sheet (if applicable)

Complete a QA Participant Information Sheet if your project will include any participants to whom you wish to provide information about your project, but from whom you are not required to obtain written consent.

This statement can be provided to participants separately or it may be inserted as cover note to questionnaire or surveys.

Note: If you are gaining written consent your project does not meet the requirements for QA review.

5. Provide evidence of relevant authorisations

Where multiple departments are involved in the project, you may either:

  • submit a signed Statement of Approval form signed by the head of each RMH service or department used to conduct the project; OR
  • provide email evidence of support for the project by the head of each department.
6. Complete a Health Information Services QA form (if applicable)

If your research involves access to paper Medical Records, complete a Health Information Services QA Form.

A Health Information Services QA Form is no longer required when accessing Medical Records via EMR/ECM.

Full details of the process, cost and conditions are outlined in the HIS form.

This form must be signed by Health Information Services Manager before the QA Application is submitted to the Office for Research.

Health Information Services ManagerEmail Address
Vanessa Sagulo, Acting ECM Operations ManagerVanessa.Sagulo@mh.org.au
7. Complete Pathology approval form (if applicable)

If your research requires the services of RMH Pathology, submit the required documentation as outlined on the Pathology clinical trials service web page.

8. Complete an Agreement (if applicable)

An agreement is required when there is another organisation involved in the project. Examples when this would apply include:

  • Data sharing with any organisation outside of RMH
  • Additional or involvement of student researchers
  • Collaborative QA projects.

The agreement captures the written agreement between parties around intellectual property, resources etc in the conduct of the project. NOTE: Where funding is to be exchanged, the project does not meet the criteria of a QA project and must be submitted for ethics and governance review as a standard application.

Process for Agreement Reviews

QA projects requiring a collaborative agreement should use the RMH MACH Research Collaboration Agreement. This template has preferred RMH text in the Schedule and ‘Drafting Help’ tips for completion. Please delete the tip comments prior to submitting your MACH for review to the Office for Research.

This template is required for RMH-lead projects (i.e. RMH authored the protocol).

Where the QA project lead organisation is not RMH, the collaborators preferred agreement may be used however these will need to be reviewed by the RMH legal team. Reviews may therefore take longer. Within the agreement, when the following terms are used, they will be taken to mean:

  • “Research project” = “Quality assurance project”
  • “Principal Investigator” or “Investigator” = “Project Lead”

Agreements will be reviewed as part of the application process. Any queries and recommended changes will be sent to the QA project main contact.

Once agreed, the MACH should be sent to any other parties for review and agreement prior to execution.

The QA Project Lead should organise execution of the agreement with a fully executed copy provided to the Office for Research.

QA acknowledgement

  • The Office for Research will provide acknowledgement of QA projects for RMH only.
  • Collaborating organisations may choose to accept the RMH review or may require the application to be reviewed under its own review process.

Please contact the Office for Research at research@mh.org.au if you have any questions.

9. Does your project involve student investigators?

For projects involving a student investigator, action the following:

  • Complete and submit a draft RMH MACH Research Collaboration Agreement identifying the student’s University as a Party to that Agreement. See Section 8: Complete an Agreement (above) for information and instructions.

Where a student:

  • is accessing RMH medical records, it is an organisational requirement that they hold an honorary appointment with RMH.
  • does not currently hold an honorary appointment, contact the relevant clinical head of department to ensure one is organised for them.
  • only has access to non-identifiable information, an honorary appointment is not required.
10. CVs for the Project Lead

Complete an Investigator Curriculum Vitae Form for the Project Lead/s (if these have not been submitted to the Office for Research in the previous 3 years) and email directly to: CVsFolder@mh.org.au.

Disregard the "clinical trials" sections and any other research only fields in the Form.

11. Obtain your Head of Department Approval
  1. Ask your manager how to arrange Head of Department (HOD) approval.
  2. Submit all QA project documents to the HOD for review and approval.
  3. The HOD will need to sign the ‘QA Head of Department Declaration’.
12. Complete a fee form

Download and complete the QA Fee Form.

The fee for review of QA projects is $100 and is payable up-front, at the time of initial submission of the project.

13. Submit your QA application

Submit all documentation to the Office for Research by email to QA Review.

This email should list all the documents submitted including the following:

  • Completed and signed QA Application Form
  • Project protocol
  • Any other forms relevant to this application, such as:
    • assessment tools
    • data collection sheets
    • statements of approval
    • agreement