Clinical Trial Research Agreements

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Clinical Trial Research Agreements

The Tasmanian public health service endorses and encourages the use of the Medicines Australia Clinical Trial Research Agreement (CTRAs) and the Medical Technology Association of Australia Clinical Intervention Research Agreements (CIRA) standardised research agreements.

The CTRAs/CIRA must include the Tasmanian Specific Clauses, which are inserted at ‘Special Conditions’ (either Schedule 4 or Schedule 7 depending upon the contract type) to ensure full compliance with Treasurer’s Instruction, ‘Contracts – Disclosure and Confidentiality in Government Contracting’.

Treasurer's Instruction, Contracts - Disclosure and Confidentiality in Government Contracting

Treasurer’s Instruction, Contracts – Disclosure and Confidentiality in Government Contracting, issued under the Financial Management Act 2016 (Tas) (“TI C-1”) prohibits the inclusion of confidentiality provisions in contracts where the Tasmanian Crown is a party unless the Head of Agency (Secretary) grants approval. This prohibition applies only to the terms and conditions of the contract itself. The purpose of this policy is to not unduly fetter public scrutiny of contracts.

Pursuant to Section 1.2 of TI C-1 a confidentiality provision may be sought by the Sponsor. The Sponsor must make the application in writing to the Department of Health requesting the contract be confidential and outlining the sections of the contract that are to be made confidential or demonstrating that disclosure is commercially sensitive to the contracting party. The request for is to be forwarded to Dr Jodi Glading, Deputy Chief Medical Officer, email: research.governance@health.tas.gov.au

Southern Eastern Border States (SEBS) panel

The Southern Eastern Border States (SEBS) panel has representatives from the health departments of New South Wales, Queensland, South Australia, Tasmania, and Victoria.

SEBS works to standardise, as far as possible, the terms and conditions of the Medicines Australia Clinical Trial Research Agreement (CTRAs) and the Medical Technology Association of Australia Clinical Intervention Research Agreements (CIRA) in an effort to streamline the administrative management of contracts for Sponsors and public health service organisations who are parties to the agreements.

The SEBS panel also considers proposed amendments and variations that are intended to accommodate, as far as possible, company-specific clauses that clarify or add to the CTRAs or CIRAs. The CTRAs or CIRAs can then be executed without the need for any amendments via Schedule 7 (or Schedule 4 in the case of the CRG, Phase IV CRO and Phase IV templates). This ensures national consistency and improves efficiencies on contract amendment negotiations.

For further information or to submit an application for amendment refer to the Medicines Australia website.

Non-Standard Research Agreements

Non-standard research agreements are not recommended for use within the Tasmanian public health services. If a Sponsor does not agree to use a standardised Medicines Australia CTRA or Medical Technology Association of Australia CIRA, the non-standard CTRA/CIRA must be forwarded by the RGO for review and if required the RGO will seek further legal advice. The RGO will liaise with the Sponsor and Legal Services until agreement between the parties is reached.