Execution of agreements
Where a research agreement is required, early consultation with the Metro North research governance office is recommended to assist with efficient review and approvals.
- 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.
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 and return or destruction of confidential information at the conclusion of discussions.
The Metro North research governance office can provide the Metro North CDA template in order to expedite review and reduce any potential legal fees.
Contact Metro North Research Governance for the Metro North Template
Master CDA
Sponsor Master CDA templates can be sent to the research governance office 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)
The National Health and Medical Research Council (NHMRC) and Medical Research Future Fund (MRFF) funding agreements require that all collaborating institutions awarded a grant must have an MIA in place, 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.
Metro North investigators will be asked to confirm their involvement, provide a copy of the Letter of Support from the funding application, provide additional detail around future site implications and involvement of Metro North, and, where appliable, confirm the funding amount.
MIA’s can be forwarded to the research governance office (RGO) via MetroNorthResearch-RGO@health.qld.gov.au.
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.
Approved clinical trial templates
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 QHEPS).
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.
Insurance
Where clinical trials involve collaborators or parties external to Queensland Health, the contract must include reference to insurance and indemnity arrangements.
For commercially sponsored clinical trials, the relevant Medicines Australia Clinical Trial Research Agreement (CTRA) and Medical Technology Association of Australia (MTAA) Clinical Investigation Research Agreement contain clauses relating to the Insurance to be provided for the project.
For collaborative or other non-commercial clinical trial, each institution will generally provide their insurance for the project. The Medicines Australia Collaborative or Cooperative Research Group (CRG) Clinical Trial Research Agreement contains specific insurance clauses.
Certificates of Currency (insurance certificates) should be submitted with the research governance application, and their expiry dates noted to ensure there is no lapse in cover. There are no requirements for specific insurance companies to be used, but the insurance company should have offices or representatives in Australia to facilitate processing of any claims that may be made.
The certificate of currency (or insurance certificate) should contain the following information:
- Full Study Title
- The type of insurance – Public and Product Liability – or equivalent such as General Liability or Clinical Trials Insurance
- The full legal name of the Australian entity acting as the sponsor
- The full legal name of the insurer (which must be approved by the Australian Prudential Regulation Authority or a foreign equivalent). All insurers are required to hold Standard & Poor’s financial rating of not less than ‘A-’.
- The period of insurance
- That the insurance coverage allows for a minimum of AUD$10 million for any one occurrence and in the annual aggregate
Generally speaking, Queensland Health will not provide insurance or indemnity for external parties.