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Contracts

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• Developing a Contract
• Research Involving Third Parties
• Research Directed by a University’s Employees or a Student
• Indemnities
• Insurance 
• Contract Approval

 

You are required to submit a Contract, Indemnity and Insurance Policy if any of the following apply to your project:

• The research will involve a third party such as a pharmaceutical company or a research organisation
• The Principal Investigator is / is not a Queensland Health employee
• The Principal Investigator is a University employee or the research is conducted by a student

 

Developing a Contract

General Guidelines

• Queensland Health defines research involving QH  facilities, staff /or patients, must be transparent and accountable in accordance with relevant legal requirements. The contract must take into account the mission, values and strategic directions of Queensland Health and the Princess Alexandra Hospital. Refer to the Research Management Policy.
• A Principal Investigator must be nominated prior to study commencement of a study. If the Principal Investigator is not a staff member of the PAH, a PAH staff member must be nominated as a ‘local onsite sponsor’.
• The contract must be made between the “The State Of Queensland Acting Through Queensland Health via the  Princess Alexandra Hospital And Health Services District” (ABN: 66 329 169 412) and the third party.
• The Principal Investigator cannot be a party to the Agreement. 
• The Contract, Indemnity and the Insurance Policies must all be submitted at the same time as the Research protocol.

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Research Involving Third Parties

The contract must, at a minimum, contain all elements listed in the Content Checklist. 

When entering into a Clinical Trial Agreement, the Princess Alexandra Hospital is governed by Queensland Health's Principles of Conduct for all Clinical Trials.   Queensland Health has developed the Clinical Trial Agreements in harmony with the Principles of Conduct, which are to be used for all Clinical Trials involving Queensland Health sites, facilities, staff or patients. They are as follows:-

• Medicines Australia Clinical Trial Agreement to be used when the parties are the State of Queensland and a Commercial Sponsor.
• The Standard Clinical Trial Agreement B is to be the State of Queensland and a Commercial Sponsor and Clinical Research Organisation (CRO), when the parties are involving Queensland Health sites, facilities, staff or patients.

Medicines Australia Clinical Trial Agreement A - PAH Standard CTA with Sponsor   

Queensland Health Clinical Trial Agreement B - PAH Standard CTA with Sponsor and CRO

Queensland Health Clinical Trial Agreement - B Schedules


For further information refer to the Research Management Policy.

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Research Directed by a University’s Employee or a Student

A sub-contract between the Princess Alexandra Hospital and the relevant University will be required.

The University employee or student must contact their University legal representative to request that the correct contractual arrangements be put in place.

 

University contacts:-

• University of Queensland: Meaghan Douglas at m.douglas@research.uq.edu.au
• Queensland University of Technology - Andrew Crowe at a.crowe@qut.edu.au
• Griffith University – Flick Baker at f.baker@griffith.edu.au

 

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Indemnities

The Princess Alexandra Hospital must exercise caution when entering into Clinical Trial Agreements, we must take care not to assume liabilities that would otherwise be attached to commercial organisations eg. pharmaceutical companies or Contract Research Organisations (CROs).

Commercial sponsors proposing to engage in clinical trials or other research must provide indemnification by using the Medicines Australia Form of Indemnity for Clinical Trials.  This document cannot be altered.

External organisations seeking PAH HREC review only, must provide indemnification by using the Form of Indemnity - HREC review only.  This document cannot be altered.

• http://www.medicinesaustralia.com.au/pages/page39.asp

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Insurance

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 isured 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.

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Contract Approval

• All contracts will be reviewed by the office of the Centres for Health Research to ensure they are appropriate and complete.
• Research applications will be forwarded to the Clinical CEO for approval when both the ethics and contract requirements have been met.

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Queensland Government