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Governance only – SSA

  • If ethical approval is being obtained from a certified HREC (other than RCH) as part of the National Mutual Acceptance (NMA) scheme,investigators from the Melbourne Children’s Campus are required to submit a Governance Only ‘Site Specific Assessment (SSA)’ Application.

    There are no closing dates for SSA applications – they can be submitted for review at any time.

    Changes to the Pre-submission process

    From 01 January 2020, all research studies must have a single unique identification number for use across the Parkville Precinct and the Melbourne Children’s Campus. This unique ID will now be the ERM Project ID. This is a 5 digit number generated in ERM when a project is created. You will find the ERM Project ID at the top right hand corner of your screen on ERM. Ex. 55555

    Please also refer to the guidance material on " How to get a project reference number." 

    With the introduction to the Parkville Precinct fully integrated Electronic Medical Record (EMR) Project we are having to move across to one precinct reference number.

    All studies are still required to  pre-register prior to submission. You can do this by completing the  pre-registration form.  Any new submissions submitted during this time will need to fill in the  pre-registration form after the 6th January 2020, however are still able to submit the REG department.

    You will need to include the ERM Project ID within the  pre-registration form and with your new submission to the REG.

    You need this number to communicate with REG and for all internal communications, as well as all supporting service departments on campus. Please quote this number in all email and other correspondence

    RCH HREC fee payment

    Please note as of the 1st July 2018 the changes to the  HREC Payment Fees. These are payable in full at the time of the initial submission of a project or amendment.

    All payments that are submitted to the Research Ethics and Governance Office at RCH must be completed using this  form or payment remittance advice (proof of payment). 

    RCH HREC Fee Payment Form 

    There are three options for payment Credit Card, Electric Funds Transfer and Internal Cost Centre Transfer.  ***Please note RCH no longer accepts American Express (AMEX) credit card payments and all credit card payments will now incur a 1.5% surcharge fee. ***

    If payment does not accompany the initial submission or amendment the Ethics review process will not be able to start until it has been received. 

    To determine whether fees are applicable to the review of your submission, please review the schedule of  Submission Fees. You do not need to submit this form if no fee applies.

    Submission process

    The following documents are required when submitting an SSA application for governance authorisation (as applicable):

    Document   Number of Copies

    RCH REG Application Coversheet 

    One electronic copy

    HREC Approval letter listing:

    - All ethically approved documents (see Handy Hints); and

    - RCH or MCRI as an approved site

    One electronic copy
    Protocol ( templates and guidance) One electronic copy
    Human Research Ethics Application (HREA)  One electronic copy signed by the PI
    Victorian Specific Module (VSM) One electronic copy
    Site Specific Assessment (SSA) Form

    One electronic copy signed by:

    - Associate investigators (RCH/MCRI only);

    - Head of Department; and

    - Supporting Departments (can also use Declaration Form below)

    Supporting Department Declaration  One electronic copy
    Master Participant Information Statement and Consent Form TRACKED to Site Specific (see Handy Hints below) One electronic copy
    Master Parent/Guardian Information Statement and Consent Form TRACKED to Site Specific (see Handy Hints below) One electronic copy
    Master Child / Young Person Information Statement TRACKED to Site Specific (see Handy Hints below) One electronic copy
    Investigators Brochure or Product Information  One electronic copy
    Other Participant Facing-Information e.g. flyers, letters, advertisements, questionnaires, diaries etc One electronic copy
    Budget (for the site) One electronic copy
    Research Agreement One electronic copy
    Form of Indemnity (if commercially sponsored) One electronic copy
    Insurance Certificate (if commercially sponsored) One electronic copy

    You need to submit electronic documents as separate documents. Each file name should capture the name of the document, as well as the version number and date. 

    Handy Hints (including PICF):

    • Approval Certificate: Please ensure documents listed on the approval certificates are submitted to the RGO with the same file name (and/or footer) to ensure ease of review. Inconsistent naming will delay approval times.
    • Please take the master approved document and track changes to make it specific for this site i.e. "site-specific". In this case it is only necessary to submit one file, as the RGO can hide tracked changes to view the "Master" and accept tracked changes to view the "clean site-specific".
    • Please keep the version and date consistent with the master approved version i.e. if the Master is version 1 dated 12/01/19, the site specific should also be version 1 dated 12/01/19. 
    • Ensure site specific governance documents include appropriate version controls i.e. document footers should include version controls e.g."RCH Site Specific PICF, Version 1 dated 01 March 2016 (based on Master PICF, Version 1 dated 01 March 2016)"
    • Ensure that all site specific information has been inserted and that no prompts remain in the information statement and consent forms.
    • Common omissions within the SSA form include site specific recruitment numbers and strategies.  
    • Ensure the local HREC reference number is used to identify the study e.g. 38001 or 2019.001 in all correspondence. 

    Please ensure that you submit a Governance Only SSA Application as soon as possible, preferably in parallel with the ethics submission. This is critical for applications where a non-standard agreement is used as legal review will be required, which may incur delays.