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Ongoing Management of More than Low Risk 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.

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.

 

Submission Information

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.

Click here for HREC submission deadlines and meeting dates for 2018.  Post approval submissions are due by the Agenda Closure Deadline. 

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 HREC 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.