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Clinical audit and quality assurance

This review pathway may be suitable for our staff examining our data with the intent to publish or present the data beyond this hospital's staff

This review pathway may be suitable for Peter Mac staff examining Peter Mac data with the intent to publish or present the data beyond this hospital's staff.

This pathway is only suitable for single-site applications for the Peter MacCallum Cancer Centre. If a project involves more than one site/organisation, please consult each site/organisation regarding their requirements. 

This review pathway can be used for the following types of projects: 

  • Clinical audit projects reviewing our patient data.  

  • Clinical audit projects that also collect prospectively clinical follow-up data - for example, status at last contact, date and cause of death, information related to the disease management. 

  • Negligible risk research: Research in which the only foreseeable risk is no more than inconvenience. 

  • Quality assurance or evaluation activities. These may need ethical review if they contain triggers for consideration of ethical review as listed in NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities (2014). 

IMPORTANT NOTE: The following are NOT eligible for review via this pathway: 

  • Projects that will last more than two years 

  • Projects requesting multisite ethical review 

  • Projects collecting new raw data  

  • Projects collecting data that will be transferred to external organisations 

  • Project that could determine findings that may be clinically relevant to specific participants 

  • Projects that include an intervention 

Submitting your application

On the ERM (Ethics Review Manager) submission system, complete Quality Assurance (QA) VIC Application Form, and attach the following documents:

  • Protocol (Retrospective protocol template provided on CONNECT page Clinical Research Development Tools)

  • Data Collection Tool, if needed 

  • Declaration by Head of Supporting Department form (only if support is needed from a department that does not have a member on the research team) 

  • CVs:
    • Please submit the Principal Investigator and Associate Investigator CVs, if not already submitted within the last three years
    • Please submit CVs in the following format: "SURNAME FORENAME CV DATE"
  • GCPs:
    • Please submit the Principal Investigator GCP, if not already submitted within the last three years. Principal Investigators on clinical audit and quality assurance research projects are strongly encouraged to undertake GCP training 
    • Further information regarding recommended training can be found here: New Governance Application - Peter MacCallum Cancer Centre (see Investigator Training Requirements)
    • Please submit GCPs in the following format: "SURNAME FORENAME GCP DATE"

Submission due date: Submit at any time. 

Responding to committee queries 

The Principal Investigator will be advised of the outcome of the review and any further queries or requirements. 

To respond:

  • Please provide a response to each point in the committee review memo - for example, provide explanation/further information; if revisions have been made in response, state what and where.
  • Please provide any revised project documents in tracked and clean format.
  • Please submit your response via email to This email address is being protected from spambots. You need JavaScript enabled to view it..

Governance review  

No extra documents are required.

Contact 

  • Email: This email address is being protected from spambots. You need JavaScript enabled to view it. 
  • Phone: (03) 8559 7544

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