Ongoing Management of Multi-site Research

 

Please note that this section does not apply to the following types of studies:

 

Important information for researchers 

As from 16 July 2018 the Ethics and Governance database and submission process has changed.  All applications and post approval documents will need to be created and submitted through the newly released Ethics Review Manager (ERM) Database for approval.  ERM replaces Online Forms.

Post-Approval Submissions

All post-approval submissions including amendments, progress reports, adverse events etc. must now be submitted through ERM. They can no longer be submitted by email.  

If you already have an Online Forms login and password it will transfer to ERM.  If your Online Forms login and password does not work, contact Helpdesk@infonetica.net

If you have not previously used Online Forms you will need to register in ERM.

The instructions on our website will be updated to reflect these changes.  

Where do I find ERM?

https://au.forms.ethicalreviewmanager.com/Account/Login

The staff from the Office for Research will be able to assist you.  Call Kim Sherry on 9784 2680 to make a time to call in or email Kim, KimSherry@phcn.vic.gov.au with your questions.

 

Ethical and Scientific Review

Ethical and scientific review of post approval amendments and reports relating to projects reviewed under the Streamlined Ethical Review Process (SERP) including National Mutual Acceptance (NMA) is undertaken by the accredited Reviewing HREC that provided the original approval.

For multi-site clinical trials – processes and template are available from: http://www.health.vic.gov.au/clinicaltrials/

For multi-site health and medical research – processes and templates are available from: http://www.health.vic.gov.au/healthandmedicalresearch/index.htm

Principal Investigators must be aware of their responsibilities under these review systems.

 

Research Governance/SSA Authorisation

All post-approval submissions must be completed through ERM Applications.

The forms and documents required for post-approval submissions will depend on type of submission.

A list of documents required is available from here.  Please note this document also contains details of the documentation required for new applications.

 

Submission Requirements

Post-approval submissions are to be submitted electronically via ERM Applications. The Office for Research no longer accepts submissions via email unless you have received specific advice to do so.

Research submissions will not be processed if they do not comply with the submission requirements.  You will be advised through ERM if further information is required. 

 

Fees

Fees are applicable for review of protocol amendments or new/amended Investigator’s Brochures initiated by a commercial sponsor. Please ensure you are aware of any applicable fees and payment requirements prior to submitting.

 

Notification of Review Outcome

The outcome of the research governance/SSA review will be sent via ERM by the Office for Research within 7 days of the meeting. 

Research amendments must not be implemented until notification of approval has been received from the Reviewing HREC and Peninsula Health.