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  • Home
  • Research Units
    • Allied and Community Health
    • Anaesthetics
    • Emergency Medicine
    • Intensive Care
    • Medicine and Specialties
    • Paediatrics
    • Pharmacy
    • Professorial Academic Unit
    • Radiology
    • Surgery and Specialties
    • Women’s Health
  • Ethics & Governance
    • Office for Research
    • New Ethics Applications
    • New Governance Applications
    • Post Approval Submissions
    • Forms, Policies & Templates
    • Human Research Ethics Committee
  • Clinical Trials
    • Partner with Peninsula Health
    • Participating in Research
    • Search for a Clinical Trial
  • Support Our Work
  • News

Post Approval Submissions

Ongoing Management of Approved Research

All research projects approved to commence at Peninsula Health must comply with the conditions of approval detailed in the approval to commence letter. 

Projects approved to commence at Peninsula Health that have been reviewed under SERP including NMA must also comply with the requirements of the Reviewing HREC.

Compliance with the following is required:

  • The principal investigator must immediately report anything which might warrant review of ethical approval of the project in the specified format, including:
    • any serious or unexpected adverse events
    • unforeseen events that might affect continued ethical acceptability of the project
  • Proposed changes to the research protocol, conduct of the research, or research completion date must be provided for review in the specified format
  • Notification, giving reasons, must be sent if the project is discontinued at a site before the expected date of completion
  • The principal investigator must provide an annual report and at completion of the study a final report, in the specified format

Non-compliance with the conditions of approval may result in temporary suspension or permanent withdrawal of approval.  

Submission of post approval documentation will depend on the review pathway. Click on the below link relevant to your project for further information.   

Application Type

Review Pathway

Low and negligible risk research (single-site)

Human Research Ethics Committee (HREC)

More than low risk research (single-site)

Human Research Ethics Committee (HREC)

Multi-site research

Research Governance (SERP including NMA)

 

Contact us

Director of Research
Professor Velandai Srikanth
velandai.srikanth@monash.edu
(03) 9788 1722

Manager, Office for Research
Lee-Anne Clavarino
lclavarino@phcn.vic.gov.au
(03) 9784 2679

Ethics and Governance
HREC@phcn.vic.vic.au

Research Governance
RGO@phcn.vic.gov.au
(03) 9784 2680

Office 2Q09, Ngarnga Centre
PO Box 52
Frankston Hospital
Frankston VIC, 3199

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