Quality Assurance (QA) projects are an essential and integral part of health care delivery.
COVID-19 Guidance for Research Studies including Clinical Trials
For updates on how COVID-19 impacts research (including review of QA applications) and updated requirements at Melbourne Health please visit our COVID-19 webpage.
For new Covid-19 related studies please also refer to information from the Co-ordinating Office for Clinical Research (DHHS) (visit the COVID-19 webpage and scroll down).
The QA process has changed
The QA application and review process has been updated and more importantly streamlined based on user feedback requesting clarity on:
- determining when a project meets the QA criteria
- the QA process
Please note the following highlights of changes:
- MH will provide QA review and acknowledgement for MH sites only
- the QA study must be complete within 2 years of the date of the acknowledgement email
- amendments to the project are no longer possible
- if the project is to continue beyond 2 years, a new QA project will need to be submitted
- there is a new stand-alone form for Head of Department approval and declaration
- the QA form has had minor amendments to reflect the changes
- Multi-site QA projects will receive acknowledgement for the MH site only. Collaborating organisations may choose to accept the MH review or may require the application to be reviewed under its review process.
For existing QA projects:
- amendments to the project are no longer possible
- approval period is 2 years from 23 March 2020
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. Those conducting QA activity must consider a range of issues including consent, privacy, relevant legislation, professional standard, and whether ethical review is required.
Key documents and issues - you should familiarise yourself with the following:
- The Australian Code for the Responsible Conduct of Research 2018
- The National Statement on Ethical Conduct in Human Research 2018
- NHMRC Guidelines on Ethical Considerations in Quality Assurance and Evaluation Activities – March 2014
- Any other relevant Commonwealth, state, or territory legislation or guidance
- Principles of Research Integrity
- Data management and storage requirements (refer to MH guidelines)
- Publication and authorship (refer to MH guidelines)
Path to Research Success
Need help navigating your way through a research study? The Path to Research Success provides an overview of the key elements and helpful tips that are crucial to conducting a successful QA or research project.
Is my project quality assurance?
For your project to be considered QA you must be able to answer:
- ‘YES’ to these statements:
- does the project aim to use the outcomes to improve delivery of health care?
- does the project seek to identify and/or quantify problems within, or impediments to, good health care delivery and to identify ways of improving those problems?
- does the project seek to evaluate current health practices or to monitor the introduction of a new practice?
- ‘NO’ to these statements:
- the project may cause more than discomfort
- the project involves more risk than just inconvenience (physical, psychological and information/privacy risks)
- could this project infringe on ethical principles that guide human research (merit and integrity of the project, justice, beneficence and respect)
- written consent from the participants required
- the project could impact the reputation and/or privacy of researchers and/or the organisation
- the project involves targeted data analysis of minority or vulnerable groups
- the project involves secondary use of data - use of using data/ analysis from QA activities for another purpose
- the project intends to gather new medical, health or sensitive information
- the project proposes activity that significantly deviates from standard practice
- the project aims to generate new generalisable knowledge i.e. by testing a hypothesis, collect or use data, tissue and / or blood samples from patients, carers, or their relatives, and require written consent
- the project involves comparison of cohorts, randomisation or the use of control groups or placebos
- a person would reasonably expect the project to be reviewed by the HREC
- money will be received from, or paid to MH, by an external entity
- the project involves collaboration with an commercial entity
Is my project actually research?
If you answered 'No' and/or 'Yes' respectively to points 1 and 2 above, your project is considered to be research and you will need to submit an ethics application.
The OFR will acknowledge the QA project via email and provide you with an application reference number and confirmation of the study period.
Please retain and file 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.
- 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
Note: multi-site QA projects will receive acknowledgement covering ethics and governance review for the MH site only. Collaborating organisations may choose to accept the MH review or may require the application to be reviewed under its review process.
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
However if you intend to publish the results, documentation must be kept for 5 years post publication or 5 years from the decision not to publish.
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.
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.
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 MH server)
- who will have access to the data
- If any personal identifying data is collected, how will confidentiality be maintained, stored, protected etc.
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.
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.
Where multiple departments are involved in the project, you may either:
- submit a signed Statement of Approval form signed by the HOD of each MH department used to conduct the project; OR
- provide email evidence of support for the project by the head of each department.
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 the Health Information Services Manager, before the QA Application is submitted to the Office for Research.
The Office for Research will provide acknowledgement of QA projects for MH only.
If there is another site involved they will need to obtain their own QA approval. This may be the acceptance of the MH review.
An agreement is required when there is another organisation/s involved in the project. For example:
- when data will be shared (received or sent) with another site (including health services and universities) and/or
- when students are involved in the study
The agreement will outline the key details, e,g., the parties involved, arrangements for intellectual property, resources, funding and ownership of results, etc.
NOTE: If money will be received from, or paid to MH, by an external entity then the project does not meet the MH criteria of a QA project and must be submitted for ethics and governance review.
Complete a draft agreement:
Complete a draft agreement to be reviewed as part of the QA application:
- MACH Research Collaboration Agreement: For all collaborative projects. This includes interstate and overseas sites.
This template is required for MH lead projects (i.e. MH authored the protocol), however if the protocol was written by the collaborating partner, the template provided by that partner may be used.
Note: when the following terms are used, they should be taken to mean:
- “Research project” = “Quality assurance project”
- “Principal Investigator” or “Investigator” = “Project Lead”
For assistance refer to the MH Guide to completing the MACH agreement (with comments)
Review of the agreement:
Draft agreements must be submitted for review with the QA applications.
The Office for Research will manage the agreement review process and signing of the agreement should only occur once all parties involved (organisations) have agreed to the terms of the agreement.
The signing process:
The Office for Research will manage the MH signing process for the agreement once the review process has been completed.
Complete the Approval to Examine Records for the Purpose of Research form.
Any student who is involved in the examination of Melbourne Health medical records for the purposes of research is required to complete this form which must also be co-signed by the Principal Investigator.
In the circumstances where the Principal Investigator is not a Melbourne Health employee, a Melbourne Health Senior Medical Staff member is required to sign the form.
Please refer to point 7 to complete an agreement for these studies.
Ask your manager how to arrange Head of Department approval.
Submit all QA project documents for review and approval by the Head of Department.
The Head of Department will need to sign the ‘QA Head of Department Declaration’.
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