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
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.