Research agreements2024-07-16T00:45:43+00:00

Research agreements

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    Confidentiality/Non Disclosure Agreements (CDA)

    A confidentiality agreement outlines the obligations and responsibilities of the parties involved, including: preventing unauthorised disclosure of confidential information to third parties without consent of the disclosing party; return or destruction of confidential information at the conclusion of discussions.  It is recommended to use the Metro North template in order to expedite review and reduce any potential legal fees. 

    Confidentiality and Disclosure Agreement

    Master CDA

    Sponsor master templates can be sent to the research governance office (RGO) via MetroNorthResearch-RGO@health.qld.gov.au, noting a legal review fee may apply. 

    Study specific CDA

    Sponsors who wish to use their own template for individual studies need to go via the relevant research department, who will review and forward to the research governance office, noting a legal review fee may apply.  

    Multi-Institutional Agreements (MIA)

    Both the National Health and Medical Research Council (NHMRC) and The Medical Research Future Fund (MRFF) funding agreements require that an MIA must be in place with all collaborating institutions even when no funds are to be transferred between the institutions. Standard agreement templates are currently in use within the Group of Eight (Go8) Universities.   

    MIA’s can be forwarded to the research governance office (RGO) via MetroNorthResearch-RGO@health.qld.gov.au.   

    The Metro North investigators will be asked to confirm their involvement, provide a copy of the application Letter of Support, where appliable, confirm the funding amount and provide additional detail around future site implications and involvement.  If Metro North is a site for future activities, further detail on the status of ethics and research governance. 

    Investigator-initiated research agreements

    A research agreement is required for all research in which an external organisation is involved in the research. This includes sponsored, collaborative and student research (e.g. Research Higher Degree).  

    If Metro North is the sponsor or leading the study, please request the RGO to draft the agreement with your site specific assessment (SSA) application, the request should be documented in the SSA cover letter. 

    If Metro North is not the sponsor, please contact the relevant research contracts officer at the sponsoring organisation. Please do not submit your SSA until you have made contact with the sponsoring organisation.  

    At the time of SSA review, the RGO will review the agreement and liaise with the sponsor to finalise.  The agreement will be provided to the delegate for execution at the time of consideration of the research governance approval.  

    Templates

    Clinical Trial agreement

    In most instances the site Clinical Trial Coordinator will review and confirm all details in the clinical trial agreement. The agreement should be partially executed (signed by the Sponsor and PI) and provided with the SSA submission. In circumstances where the Sponsor or Trial Coordinator wishes the RGO to review the draft agreement prior to signing, this can be uploaded to ERM with the SSA application.  The request should be detailed in the cover letter.  

    Project ID/ERM Number on the front page of the Clinical Trial Agreement

    • Please add the Project ID/ERM number to the front page of the contract.   
    • The number does not alter the body of the agreement. 
    • For example, the number can be added to the footer in brackets after the site, study name or protocol number; or in brackets after the Contact for Notices;  
      • Research Ethics and Governance Manager (ERM Project ID: 12345)  
      • Site: RBWH (ERM Project ID: 12345) 
      • Study name: A Randomised Controlled Trial of Drug A versus Drug B (ERM Project ID: 12345) 
      • Alternatively the Project ID can be included in the footer. 

    Details of parties 

    Name of Institution: Metro North Hospital and Health Service
    Address:  Level 14, Block 7,  

    Butterfield St  

    Herston QLD 4029 

    ABN:  18 496 277 942 
    Contact for Notices:  Research Ethics and Governance Manager  
    Email:  MetroNorthResearch-RGO@health.qld.gov.au 
    Phone Number:   07 3647 9550 

    Schedule 1: Key Information

    • Complete all details as per the information requirements in Schedule 1. 
    • Where there is competitive recruitment, include the proposed target/maximum number of participants to be recruited at the site. This information is used to estimate the total contract value, which is a requirement to ensure compliance with the Metro North Financial Delegation Framework 
    • Check that recruitment period reflects current timelines.  

    Schedule 2 Payments/Budget

    • The budget should always be endorsed by the site Business Manager and/or Research Business Manager.   
    • Metro North does not endorse a withholding fee or retainage, any reference to this should be removed.    
    • The email address for all remittance advices is: MetroNorthReceipting@health.qld.gov.au

    PAYEE Information

    Payment under this Agreement shall be made payable to:

    Payee (Institution):  Metro North Hospital and Health Service 
    Address:  Level 14, Block 7,  

    Butterfield St 

    Herston QLD 4029 

    ABN/Tax Identification Number  18 496 277 942 
    Payee Contact Name:   Site coordinator/administrative officer or business manager as per departmental/facility process 
    Telephone Number:  Site coordinator/administrative officer or business manager as per departmental/facility process 
    Email:  Site coordinator/administrative officer or business manager as per departmental/facility process 
    VAT Registration Number (if applicable):   

    Details for payment by bank transfer

    Payment details for bank transfer only

    Account holder:  Metro North Hospital and Health Service 
    Account Name:  Metro North HHS Operating Account 
    Bank Address:   Queensland Government Banking Centre 

    240 Queen Street 

    Brisbane Qld 4001 

    Account No.:  1003 1010 
    Bank:  Commonwealth Bank of Australia 
    BSB  064 013 
    IBAN:  N/A 
    BIC (SWIFT) Code:  CTBAAU2S 
    Additional Information  add site cost centre and name of Trial

    Schedule 4 Special Conditions (CTRA-CRG) /Schedule 7 Special Conditions (CTRA)

    • Special Conditions are used when the sponsor wishes to amendment the standard/approved clauses in the Medicines Australia clinical trial template. 
    • Special Conditions need to be approved by the National Clinical Trials Agreement Panel (NaCTA).   
    • If you are unsure whether Special Conditions have been approved by NaCTA, you can request a copy of the NaCTA approval from the Sponsor. 
    • To make an application to NaCTA, refer the sponsor to the Medicines Australia website.  
    • In circumstances where Special Conditions are included solely for Metro North, clearance from Metro North Legal rather than NaCTA is required.  A separate legal review/discretionary fee may apply.  

    Approved clinical trial templates

    Medicine Australia’s Clinical Trial Research Agreements

    Medical Technology Association of Australia Clinical Investigation Research Agreement.

    Execution of Agreements

    • Only the Metro North Health Chief Executive or delegated authority can authorise an agreement upon receiving a recommendation from the research governance office.   
    • The Metro North Research Governance Officer will arrange for agreements(s) to be executed; in accordance with the Metro North Financial Delegation Framework.  
    • Agreements are signed in conjunction with the Site-Specific Assessment approval. 
    • The Agreement may be executed in any number of counterparts. All counterparts are taken together to constitute one fully executed Agreement.   
    • A combination of DocuSign (for Sponsor-signature), wet-ink and digital certificate (adobe certificate) is permitted and legally binding. 
    • The Metro North delegate does not use DocuSign. 
    • The Metro North Delegate will sign Adobe Digital Certificate or wet-Ink. 
    • Please advise via the cover letter if wet-ink signature is required.   

    Research governance 

    Back to the research governance page

    Clinical Trials Documentation

    All clinical trials require additional documentation for governance approval.

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