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.
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
Prepare a detailed protocol that includes information on all steps and processes that will be conducted for the project. Project managers are encouraged 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 (for example, on the RMH server)
- Who will have access to the data
- If any personal identifying data is collected and how will confidentiality be maintained, stored and protected
Download and complete the QA application form.
Ensure that you complete the Declarations section of the application 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
Provide a current copy of the Principal Investigator's Curriculum Vitae (CV) if one has not been submitted to the Office for Research in the previous three years. Email the CV to research@mh.org.au.
Investigators who do not have a CV on hand may complete and submit an Investigator Curriculum Vitae form instead. For the purposes of QA, you can disregard the "clinical trials" sections and any other research-only fields in the form.
Ask your manager how to arrange Head of Department (HOD) approval. Submit all QA project documents to the HOD for review and approval.
The HOD will need to sign the QA Head of Department Declaration.
Download and submit the New Project Fee Payment form from the Office for Research intranet page (internal staff only).
Section 2: Complete these components as they apply to your project
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 a cover note to questionnaires or surveys.
Note: If you are gaining written consent, your project does not meet the requirements for QA review.
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
Departmental requirements
In addition to submitting SoAs, the following departments require additional information. Please complete all as they apply to your project.
Pathology
Visit the Pathology Clinical Trials web page for instructions
Health Information Services (HIS)
If your research involves access to paper Medical Records, complete a HIS Statement of Approval for QA.
The HIS Statement of Approval for QA needs to be signed by the HIS Manager before submitting your application to the Office for Research. This form is no longer required if you are accessing electronic medical records via EPIC.
Health Intelligence / EMR
If you require assistance obtaining data extracts from EPIC and/or Health Intelligence, log a request via IT Service Now portal and provide details of the data extract. Include the allocated ticket number from Service Now in your QA submission.
An agreement is required when there is another organisation involved in the project. The agreement captures the written agreement between parties around intellectual property, resources in the conduct of the project. Examples when this would apply include:
- Data sharing with any organisation outside of the RMH
- Additional personnel
- Involvement of student researchers
- Collaborative QA projects
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 an agreement need to contact the Office for Research at research@mh.org.au to obtain the appropriate agreement template.
Where the QA project lead organisation is not RMH, the collaborators preferred agreement may be used. Agreement will need to be reviewed by the RMH legal team and therefore review may 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 agreement should be sent to the other parties for review and agreement before 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
Does your project involve students? They may need an honorary appointment!
- Where a student is accessing RMH medical records, it is a requirement that they hold an honorary appointment with the RMH.
- If the student does not currently hold an honorary appointment, contact the relevant clinical head of department to ensure one is organised for them.
- In instances where are student only has access to non-identifiable information, an honorary appointment is not required.
Section 3: Submission process
Submit all documentation to the Office for Research by email to ethics@mh.org.au.
The email should list all the documents contained within, including the following:
- Completed and signed QA Application Form
- Project protocol
- Assessment tools
- Data collection sheets
- Statements of approval
- Agreement
- and any other forms relevant to the application
Will I be given a QA project number?
Yes, however the Office for Research will assign a project number for your QA application after receiving your submission. This number will be emailed to you within five business days.
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
QA projects will receive acknowledgement covering ethics and governance review for RMH only. Other organisations may choose to accept the RMH review or may require the application to be reviewed under their own governance 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.