Requirements for commencement of clinical trials
The two requirements for commencement of a clinical trial are:
- HREC approval
- 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
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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.