Clinical trials research governance2024-06-14T03:08:30+00:00

Clinical trials research governance

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    If you are a Metro North researcher intending to conduct a clinical trial of an unapproved device or medicine (including not approved for the specific cohort, or dose) sponsored by Metro North, you must seek approval to do so prior to submitting your ethics application via  

    Clinical trial agreements

    An agreement is required for all clinical trials involving an external organisation  

    More information on agreements

    Good Clinical Practice (GCP)

    Principal Investigators (PI’s) of clinical trials must provide evidence of accredited GCP certification undertaken within the previous 3 years. Evidence of GCP certification will form a requirement for Site-Specific Assessment (SSA) authorisation. 

    More information on GCP 

    Clinical Trials Notification (CTN)

    A copy of the eCTN registration must be included with the application.  

    Once the notification process has been completed, the approval letter should be submitted to the Research Governance Office via ERM. The CTN lodgement may occur after governance authorisation for the study has been issued. If this occurs, the CTN registration notification should be submitted via ERM as a post-authorisation notification.  For CTN details please refer to the CTN Information Sheet. 

    Metro North Health approving authority (for studies to be conducted at Metro North) 

    Approving authority  Metro North Hospital and Health Service 
    Name   Adjunct Professor Jackie Hanson 
    Position   Chief executive, Metro North Health 
    Phone number   07 3647 9550   

    Radiation Dose and Risk Assessment Report

    For all studies, a Radiation Dose and Risk Assessment Report is required.

    More information on the this report

    Standard Form of Indemnity

    Metro North Hospital and Health Service (ABN 18 496 277 942), Block 7 Level 14, Butterfield Street, Herston, Qld 4029, Australia 
    Medicines Australia Form of Indemnity for Clinical Trials  

    Other supporting documentation

    Depending on the clinical trial, other documentation may be required.  


    Please complete the relevant fee template and submit with your application. 

    Research governance 

    Back to the research governance page

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