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: