This review pathway may be suitable for Peter Mac staff examining Peter Mac data with an intent to publish or otherwise present the data beyond the staff of this hospital.
This review pathway can be used for the following types of projects:
- Clinical audit projects reviewing Peter Mac patient data.
- Clinical audit projects that also collect prospectively clinical follow-up data e.g. 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 require ethical review if they contain triggers for consideration of ethical review as listed in NHMRC Ethical Considerations in Quality Assurance and Evaluation Activities (2014).
- 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
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 submission system, complete Quality Assurance (QA) VIC Application Form , and attach the following documents:
- Protocol (a template protocol suitable for a simple Retrospective project is provided if required) NOTE: The protocol must have a version/date in the document e.g version X dated day month year.
- Data Collection Tool, if required
- Declaration by Head of Supporting Department form (only if support is required from a department that does not have a member on the research team)
SUBMISSION DUE DATE: Submit at any time.
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 e.g. 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.