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Multi-Site Clinical Trials

As part of the Victorian Government’s initiative to streamline ethical review of multi-site research, a new system has been developed for review of multi-site clinical trials. The central system for ethical and scientific review of multi-site research was implemented in November 2009 and is overseen by the Consultative Council for Human Research Ethics (CCHRE) and supported by a Coordinating Office.

Peninsula Health have signed a Memorandum of Understanding with the Consultative Council in order to participate in this system and are considered an accepting site.

The following Human Research Ethics Committees have been accredited by the Consultative Council as reviewing HRECs

  • Alfred Health
  • Austin Health
  • Melbourne Health
  • Peter MacCallum Cancer Centre
  • Southern Health
  • St Vincent’s Hospital (Melbourne)

By signing the Memorandum of Understanding, Peninsula Health has agreed to accept the ethical and scientific review of multi-site clinical trials (for which Peninsula Health is a participating site) undertaken by one of the reviewing HRECs listed above.

The new system aims to:

  • Provide a faster, more efficient process to conduct clinical trials at multiple sites and speed up product development for world markets
  • Improve delivery of new treatments to patients early in drug/device development

The new system separates ethical review from research governance and there are specific forms and requirements for each of these two processes.

  • HREC Review (undertaken by one of the reviewing HRECs)
  • Site specific assessment authorisation (research governance undertaken by Peninsula Health)

Further information and forms for applying for ethical review and site specific assessment authorisation are available from the CCHRE website.

Researchers can also contact the Peninsula Health Research Program for further information.

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