Quality assurance (QA) projects are an essential and integral part of improving the quality of healthcare service and delivery. 

Not sure if your project is quality assurance?

At times it can be difficult to determine whether a project is quality assurance or research. We have a series of questions for you to consider to help clarify whether you need to apply for quality assurance acknowledgement or research ethics approval.

Is my project quality assurance?

Submit your project for Quality Assurance review

Section Mandatory As applicable
Section 1: All components in this section are mandatory and must be completed
Section 2: Each component to be completed where applicable to your project
Section 3: Submission

Section 1: Mandatory components

1a. Prepare the study protocol
1b. Complete the QA application form
1c. CVs for the Project Lead
1d. Obtain your Head of Department Approval
1e. Complete a fee form

Section 2: Complete these components as they apply to your project

2a. Complete the Participant Information Sheet (if applicable)
2b. Provide evidence of relevant departmental approval
2c. Complete an Agreement (if applicable)

Section 3: Submission process

3. Submit your QA application

QA acknowledgement

The Office for Research 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 Office.

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

Also note:

  • If the study is to continue beyond two 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.

Amendments to QA projects

The Office for Research will acknowledge minor amendments to approved Quality Assurance applications. A minor amendment is, for example, addition of personnel or an administrative change. If your amendment is considered substantial, the Office for Research may, at its discretion, direct you to resubmit a new Quality Assurance application.

How to submit a QA amendment

QA Amendments need to be submitted by email and contain the following information:

  • An explanation detailing the reason for the proposed changes to the project
  • Provide "marked-up" and "clean" copies of the updated documents which may, for example, include the QA Application Form, Project Protocol. 
  • Obtain Head of Department (HOD) approval. The HOD will need to sign a new Head of Department declaration in support of the project and the proposed changes
  • Provide a table in the body of the email listing all the documents attached for review
  • Download and complete the Amendment Fee Payment form from the Office for Research intranet page (internal staff only). 
  • Submit to the email address listed below

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 RMH's improvement team via email at RMH Improvements Team

QA study files – documentation requirements

All documentation relating to a QA project must be kept in a study file for 12 months from completion of the study.

Documentation includes:

  • QA application documents (copy of all application documents)
  • Email correspondence (including the acknowledgement application)
  • Study data
  • Analysis
  • Reports

However, if you intend to publish the results, documentation must be kept for five years post-publication or five years from the decision not to publish.

Contact us
Office for Research: Ethics Office
Address
The RMH Parkville
300 Grattan St, Parkville, Victoria