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 2020

Alfred Health HREC Austin Health HREC  Melbourne Health HREC  Monash Health HREC  Peter MacCallum Cancer Centre Ethics committee  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
 SCD  MD   SCD  MD SCD  MD  SCD  MD  SCD  MD  SCD  MD  SCD  MD 
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 20-Jan 27-Feb  29-Jan  13-Feb  29-Jan  12-Feb  22-Jan  06-Feb  10-Feb  24-Feb  10-Jan  03-Feb  14-Jan  29-Jan 
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                        16-Jun  01-Jul 
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                        18-Aug 02-Sep
21-Sep  22-Oct  30-Sep  15-Oct  30-Sep  14-Oct  16-Sep  01-Oct  12-Oct  26-Oct  28-Aug  14-Sep  01-Sep  16-Sep 
                        22-Sep  07-Oct 
26-Oct  26-Nov  28-Oct  12-Nov  28-Oct  11-Nov  21-Oct  05-Nov  09-Nov  23-Nov  25-Sep  12-Oct  06-Oct  21-Oct 
                        20-Oct  04-Nov 
16-Nov  17-Dec  25-Nov  10-Dec  25-Nov  09-Dec  18-Nov  03-Dec  07-Dec  21-Dec  23-Oct  09-Nov  03-Nov  18-Nov 
                        17-Nov 02-Dec 
                    20-Nov 07-Dec  01-Dec  16-Dec 
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.