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July 2018 Update - Updates to application submission procedures using ERM

The Eye and Ear is now participating (from 1 June 2018) in the streamlining ethical review procedures managed by the Victorian Department of Health and Human Services.

The current system being used to submit the HREA application form is Online Forms.

Online Forms will be replaced by Ethics Review Manager as detailed below.

We are providing you with the information we have received from DHHS:

Information as at 20 July 2018

Streamlining multi-centre research  |  July 2018

 

ERM Launch!

 

The new Ethical Review Manager (ERM) system went live on 16 July 2018! 


Research applicants (researchers, trial coordinators, sponsors etc.) can access ERM at https://au.forms.ethicalreviewmanager.com.

ERM is a paperless information management system for completion, submission and storage of documentation for:

  • Human Research Ethics Application (HREA) form
  • Victorian Specific Module (VSM)
  • Site Specific Assessment (SSA) form
  • Victorian Low and Negligible Risk (LNR VIC) application form
  • All post-approval forms (e.g. amendment, progress report, safety report)

Information is available here. For ERM technical assistance, email Infonetica Helpdesk (helpdesk@infonetica.net).

 

ERM Outages


Data continues to be migrated from the old AU RED system into ERM. While this work occurs, ERM will be unavailable over the following weekends.

From

To

5.00pm, Friday 20 July 2018

5.00am, Monday 23 July 2018

5:00pm, Friday 10 August 2018

5:00am, Monday 13 August 2018

5:00pm, Friday 17 August 2018

5:00am, Monday 20 August 2018

 

SSAs for NMA

 
Information on creating a research governance/site specific assessment (SSA) form for a site outside Victoria or Queensland is available on the National Mutual Acceptance (NMA) page of the Clinical Trials and Research website. This web page also contains information on creating SSAs for Victoria and Queensland when the ethics review was performed in another state/territory.

 

Updates to Clinical Trials and Research website

 
The Clinical Trial Research and the Health and Medical Research websites have been updated with information relating to ERM. Information and documents will continue to be revised as required.

 

Digital Signature in ERM

 
ERM has functionality for digital signature on all forms (ethics application, SSA and post-approval reports). All form signatories (investigators, heads of departments etc.) are advised to use digital signature and will require their own ERM account.

Guidance on requesting and applying digital signature will be available on the Clinical Trials and Research website in due course.

 

ERM Training for Research Offices


There will be ongoing ERM training for research offices. Special training sessions on advanced functionality will be available at a later date. 

Email the Coordinating Office >>

 

ERM Training for Applicants

 
The Coordinating Office offers ERM training for researchers, applicants, sponsors and CROs.

Please email the Coordinating Office to arrange an ERM training session for your organisation.

Alternatively, you can join an online ERM training session. These will be available on an ongoing basis. Upcoming sessions are:

Date

Time

Join the Meeting

Thursday 2 August 2018

2.00pm - 4.00pm

https://global.gotomeeting.com/join/375781285
or
Phone: 02 8355 1050
PIN: 375-781-285 

Thursday 9 August 2018

10.00am - 12.00pm

https://global.gotomeeting.com/join/138312629
or
Phone: 02 9087 3604
PIN: 138-312-629 

Thursday 16 August 2018

2.00pm - 4.00pm

https://global.gotomeeting.com/join/335409413
or
Phone: 02 8355 1038
PIN: 335-409-413

Thursday 30 August 2018

10.00am - 12.00pm

https://global.gotomeeting.com/join/986001989
or
Phone: 02 9087 3604
PIN: 986-001-989