Key messages

  • The two requirements for commencement of a clinical trial are HREC approval and Site specific assessment authorisation (research governance associated with ethics review).
  • The new Ethics Review manager (ERM) will replace the Online Forms website in Victoria and Queensland on 16 July 2018.
  • The ERM website must be used to complete the HREC application and the research governance Site Specific Assessment (SSA) Form.
  • You can commence the process for ethics approval and SSA authorisation at the same time. SSA authorisation cannot be completed until HREC approval has been given.

Requirements for commencement of clinical trials

The two requirements for commencement of a clinical trial are:

  1. HREC approval
  2. Site specific assessment authorisation (research governance associated with ethics review).

The ERM website must be used to complete the HREC application and the research governance Site Specific Assessment (SSA) Form. Applicants and participating site Principal Investigators must register for an account on the ERM website (once only). IT Help Desk - Contact the IT Help Desk regarding technical questions on ERM.

Telephone: (61 2) 9037 8404 Monday to Friday 10am to 4pm EST. Email: helpdesk@infonetica.net

You can commence the process for ethics approval and SSA authorisation at the same time. However, it should be noted that SSA authorisation cannot be completed until HREC approval has been given.

Expert Scientific Review early phase clinical trials toolkit

A scientific expert review toolkit has been developed for Investigators, sponsors, scientific expert reviewers and HRECs to support safety in early phase clinical trials for Victorian participants. Guidance on the Scientific Expert Review Toolkit is now available.

Scientific expert review proformas to assist in the assessment of an early phase clinical trial research application can be accessed by contacting the Coordinating Office at multisite.ethics@ecodev.vic.gov.au.

Reviewing Human Research Ethics Committees - meetings 2021

Alfred Health HREC

Austin Health HREC

Melbourne Health HREC

Monash Health HREC

Peter MacCallum Cancer Centre HREC

Royal Children's Hospital (Melbourne) HREC

St Vincent's Hospital (Melbourne) HREC

Angela Henjak

 

(61 3) 9076 8825

Lisa Pedro

(61 3) 9496 4035

Jessica Turner

(61 3) 9342 8530

Deborah Dell

(61 3) 9594 4605

Dianne Snowden

(61 3) 8559 7543

Sophie Gatenby

(61 3) 9345 5044

Leanne Clinch

Sola Soaga
(61 3) 9231 3924

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SCD = submission closing date
MD = meeting date

Participating Organisations

Contact details for participating Organisations and Research Governance Officers can be found on the Site Specific Assessment Research Governance page.