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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

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Phase 4 Clinical Trial Contract Research Organisation - Acting as Local Sponsor - Medicines Australia  8-March-2017 (Tasmanian special conditions)

 MTAA Standard Clinical Investigation Research Agreement May 2017 (Amended 2018) 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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