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Multi site research

  • National Mutual Acceptance (NMA) enables the mutual acceptance of a single scientific and ethical review for multi site human research. The research needs to be conducted in publicly funded health services across Victoria, South Australia, Queensland, New South Wales, Western Australia and the Australian Capital Territory. 

    Mutual acceptance under the NMA scheme requires the HREC conducting the ethical review to be certified under the NHMRC National Certification Scheme. The HREC also needs to be a Certified Reviewing HREC under the NMA scheme. 

    Please find more information outlining the process for NMA submissions when the application is across multiple states and possibly multiple computer systems.

    Further information on NMA, including a list of certified reviewing HRECs, can be found here.

    Submission process

    You need to pre-register your study prior to submission. You can do this by completing the  pre-registration form

    You also need an ERM project number.

    If you are submitting a multi-site research application to the RCH HREC, please refer to this checklist:

    Document  Number of Copies

    RCH REG Application Coversheet

    One electronic copy

    Protocol - See Guidance and Protocol templates

    One electronic copy
    Human Research Ethics Application Form  One electronic copy
    Victorian Specific Module (VSM)  One electronic copy

    Medical Physicist report   (if applicable)            

    Please note: the application will not be reviewed by the HREC until this is provided. 

    One electronic copy
    Master Participant Information and Consent Form  One electronic copy
    Master Parent/Guardian Information and Consent Form  One electronic copy
    Master Child Information Sheet One electronic copy
    Investigators Brochure (or Product Information if IB is unavailable) One electronic copy
    Peer Review Proforma (please see the  process for requirements) One electronic copy 
    Other documents: flyers, letters, contact forms, advertisements, questionnaires, diaries etc One electronic copy

    If your study is being conducted at or by the Melbourne Children's Campus (incorporating RCH, MCRI and/or the University of Melbourne, Department of Paediatrics), governance authorisation will occur concurrently with ethical review. In this case, please refer to the the following checklist:

     Document Number of Copies
    Site Specific Assessment Form (SSA) One electronic copy       
    Research Agreement (RCH/MCRI) One electronic copy
    Standard Form of Indemnity (RCH/MCRI) One electronic copy
    Insurance Certificate One electronic copy
    Site Specific Parent/Guardian Information and Consent Form One electronic copy
    Site Specific Participant Information and Consent Form One electronic copy
    Site Specific Child Information Statement One electronic copy
    Site Specific documents: flyers, letters, advertisements, questionnaires, diaries etc One electronic copy
    Supporting Department Declaration Form/s - if applicable One electronic copy per supporting department
     MCRU Supporting Department Declaration Form - if applicable One electronic copy of the signed approval - PDF

    You must upload all of these documents to ERM. Give each of your documents a clear file name that includes the version number and date. The version number and date in the file name should be the same as the version number and date in the body of your document. 

    Deadlines

    You need to submit high risk research to the REG office by a deadline. See the HREC and DTS meeting dates for information about these deadlines. You can submit low risk research to us any time. 

    FAQs

    What is a CPI and what responsibilities do they have?

    The Coordinating Principal Investigator (CPI) is a local PI who has agreed to take responsibility for submitting the ethics application, obtaining approval and fulfilling all ongoing reporting requirements associated that such approval. 

    For additional information, please review the CPI Responsibilities document. 

    Is there a process to help me prepare and submit my application?

    The following process maps may be useful when preparing the submitting an application:

    What is the difference between ethical approval and governance authorisation?

    Ethical approval can only be granted by a fully constituted and certified Human Research Ethics Committee (HREC). Ethical approval is required for all research involving humans, irrespective of capacity. 

    Governance authorisation is granted by the CEO, or delegate, at each individual site, and is the final requirement before any research can begin. The scope of governance authorisation is different at each site. However, generally it requires the submission of all HREC approved documents along with a Site Specific Assessment Form and Site Specific Informed Consent Documents. 

    This process also generally involves the review and authorisation of any legal/regulatory documents, such as indemnities and clinical trial research agreements. 

    Do I need a Medical Physicist Report?

    All research projects that involve ionising radiation, regardless of whether the procedures are part of routine clinical care or additional to it, should complete the  Medical Physicist Report Request form. The RCH  RSO can be contacted for assistance to complete this form. As applicable, the Medical Physicist report must be included as part of the ethics application. If the Medical Physicists Report advises that the Department of Health (DH) must be notified, the project can only be notified to the DH once the project has ethics approval and authorisation by RCH. It is the responsibility of the researcher to notify DH.

     Please note: the application will not be reviewed by the HREC until the Medical Physicist Report is provided. 

    Do I need to submit an eCTN?

    If your project includes one of the following, a Clinical Trial Notification (CTN) to the Therapeutic Goods Administration (TGA) is required:

    1. A product not entered on the Australian Register of Therapeutic Goods(ARTG), including any new formulation of an existing product or any new route of administration; or
    2. Use of a registered or listed product outside the conditions of its marketing approval.

    How do I lodge an eCTN?

    Sponsors are required to complete an eCTN form online; the eCTN form requires site contact details to be included. For RCH/MCRI, the relevant details can be found here.  

    The new process is as follows:

    • Sponsors should log into the system, complete the form and submit a hard copy draft of the eCTN at the time of ethics submission. This replaces the hard copy blue CTN form which we no longer require. 
    • Once ethics and governance approval has been issued, the sponsor should log back into the system and submit the eCTN. 

    For studies where MCRI is the sponsor: the Principal Investigator (or delegate) must make an appointment with the Melbourne Children's Trial Centre (MCTC) to complete the eCTN. As the sponsor must be the one to lodge the eCTN, MCTC has taken this role for MCRI (and have the primary account). MCTC can be contacted by email at  mctc@mcri.edu.au.

    Departments that conduct a large amount of CTN research can talk to MCTC about gaining a secondary account/log-in to create their departments eCTN forms which can then be lodged by MCTC (on behalf of the sponsor) once approved.

    In the event that RCH HREC is providing HREC review only (i.e. the study is being conducted outside the Melbourne Children's): The sponsor e.g. commercial or another institution acting as the sponsor, will need to lodge the form directly to the TGA.

    The Therapeutic Goods Act requires the sponsors maintain evidence of approval from all necessary parties, allowing the study to start. In place of the hard copy signatures previously captured by the blue CTN form, the following now applies:

    • Evidence of Principal Investigator authorisation is the signed declaration within the HREA or SSA;
    • Evidence of HREC approval is the HREC approval letter;
    • Evidence of Institutional authorisation is the governance authorisation letter; and
    • Evidence of Sponsor approval is the submission of the eCTN. 

    Is there a fee for the review of multi-site research?

    To determine whether fees are applicable to the review of your submission, please review the schedule of  Submission Fees.Fees are payable at the time of submission.

    What are the review and approval timelines?

    The time to approval following submission to the Ethics Office is approximately six weeks. However, if the application is incomplete and/or of insufficient quality, additional information will be sought which will result in a longer time to approval. 

    Where can I find more information?

    You can find more information on the Clinical Trial Research Coordinating Office Website