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Research involving Metro South Health staff, premises, resources or patients may be subject to a written research contract.
Metro South Health uses Medicines Australia’s Clinical Trial Research Agreements (CTRA) as mandatory for all industry sponsored and contract research organisation sponsored clinical studies conducted within its facilities.
The Centres for Health Research provides advice on legal agreements, indemnity and insurance for projects undertaken within Metro South Hospital and Health Services.
A contract, indemnity and insurance policy are required if any of the following apply:
Metro South has recently implemented a new policy and procedure in relation to all contracts, including research contracts/agreements. Please refer to the Metro South Health contracts intranet page and complete the Research Contracts Approval and Study Execution Form for ALL studies (not just those requiring an agreement).
In a concerted effort to streamline research governance requirements, this form replaces the requirement for appropriate signatures on the SSA and ensures compliance with both Metro South Research Governance requirements and the Metro South Contracts Management Framework.
Please submit all contracts, agreements and indemnities electronically to PAH-Research@health.qld.gov.au for review and approval prior to obtaining singatures.
When obtaining signatures for the contract/agreement/indemnity, only the Metro South Health Chief Executive or delegated authority can authorise an agreement upon receiving recommendation from the Research Governance Office. Please refer to the Financial Delegations Framework. The Principal Investigator cannot be a party to the agreement; however they may sign to 'acknowledge' the agreement.
It is important that the correct legal entity is included exactly as outlined below on both the cover page of the contract/agreement, signature page and any other legal agreements such as indemnification forms.
|Name of institution||Metro South Hospital and Health Service via insert "the relevant hospital(s)”|
|Address||Insert hospital's street address|
|ABN||86 834 068 616|
|Contact for notices||Research Governance Manager, Level 7, Translational Research Institute, 37 Kent Street, Woolloongabba, QLD, 4102|
|Fax for notices||+61 7 3443 8003|
|Phone number||+61 7 3443 8050|
Research undertaken by a university employee or student requires an agreement in the form of a sub-contract between Metro South Hospital and Health Service via (the name of the relevant institution/facility) and the relevant university.
If you are a university employee or student, please make contact with your legal representative to request a contractual arrangement:
An indemnity is a contractual promise by one party to the other party from and against certain specific actions, claims or losses.
Commercial sponsors proposing to engage in clinical trials or other research must provide indemnification by using the Medicines Australia Standard Form of Indemnity for Clinical Trials.
External organisations, researchers external to Metro South Hospital and Health Service or those undertaking research in their private rooms wishing to utilise the services of the Metro South Health HREC must provide indemnification by submitting a signed Medicines Australia indemnity form.
A current public/products liability certificate of insurance from the commercial sponsor must be provided before final approval for the research proposal can be given. It must name the insured corporate entity acting as the commercial sponsor.
Insurance must contain coverage for a minimum amount of AUD$10,000,000 for any one occurrence and in annual aggregate.