Tasmanian Clinical Trial Research Agreements
Treasurer’s Instruction C1 ‘Disclosure and Confidentiality of Government Contracting’ (C1) prohibits the inclusion of confidentiality provisions in contracts where the Tasmanian Crown is a party, unless the Head of Agency grants an approval. 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 Medical Technology Association of Australia CIRA and Medicines Australia CTRAs not containing confidential provisions, Tasmanian CTRAs have amendments inserted at ‘Special Conditions’ (either Schedule 4 or Schedule 7 depending upon the contract type) to provide clarity and ensure full compliance with C1.
If you would like to apply for an approval of the inclusion of a confidentiality provision, the criteria are outlined in C1 at section 1.2.1 to 1.2.3 of the Treasurer’s Instruction, Financial Management Act 2016, Procurement Framework – Procurement Principles (effective 1 July 2019). A letter demonstrating 1.2.1 to 1.2.3 that also outlines the sections of the contract are to be made confidential must be sent to the Tasmanian Department of Health, Deputy Chief Medical Officer, Dr Jodi Glading at Jodi.firstname.lastname@example.org.
REQUESTS FOR CONFIDENTIAL PROVISIONS IN TASMANIAN CLINICAL TRIAL RESEARCH AGREEMENTS
CLINICAL TRIALS HANDBOOK
The updated Handbook provides policy guidance on the clinical 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.