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 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 

This will be a single-site application for the Peter MacCallum Cancer Centre only.  

If a project involves more than one site/organisation, please consult each site/organisation regarding their requirements. 

  • 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 

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. 

Provide a response to each point in the review memo - for example, provide explanation/further information; if revisions have been made in response, state what and where. Provide any revised project documents in tracked and clean format. 

Governance review  

No extra documents are needed. 

Clinical audit and quality assurance contact 

Email: This email address is being protected from spambots. You need JavaScript enabled to view it. 

Phone: (03) 8559 7540