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Tasmanian Clinical Trial Research Agreements

Treasurer’s Instruction 1401 ‘Confidentiality of Government Contracts’ (TI 1401) prohibits the inclusion of confidentiality provisions in contracts where the Tasmanian Crown is a party, unless the Head of Agency approves an exemption on a case by case basis.  This prohibition also applies to the Tasmanian Health Service, the legal entity which most often enters into CTRAs.  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.

Despite standard Medicines Australia CTRA not containing confidential provisions, Tasmanian CTRAs have amendments inserted at Schedule 7 ‘Special Conditions’ to provide clarity and ensure full compliance with TI 1401.

 

REQUESTS FOR CONFIDENTIAL PROVISIONS IN TASMANIAN CLINICAL TRIAL RESEARCH AGREEMENTS

Standard Medicines Australia  CTRA  8-March-2017 (Tasmanian special conditions)

Collaborative Research Group Medicines Australia  CTRA  8-March-2017 (Tasmanian special conditions)

Contract Research Organisation - Acting as a local Sponsor - Medicines Australia CTRA  8-March-2017 (Tasmanian special conditions)

CTRA-Phase-4-Clinical-Trial-Medicines-8-March-2017 extra (Tasmanian special condition)

CTRA-Phase-4-Clinical-Trial-Medicines-CRO-acting-as-Local-Sponsor-8-March-2017 extra (Tasmanian special conditions)

 

CLINICAL TRIALS HANDBOOK

The updated Handbook provides policy guidance on the clincial trials schemes administered by the Therapeutic Goods Administration (TGA). 

 Guides on the notification process for Clinical Trial Notification (CTN) scheme is available at the TGA Website

 

 

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