The Therapeutic Goods Administration (TGA) has released a new online form for the clinical trial notification (CTN) scheme. When a clinical trial is investigating the use of a product within Australia, which is not on the Australian Register of Therapeutic Goods (ARTG), or on the ARTG yet being used outside its marketing approval conditions, these notifications are required.
This form is the first of many developments intended to improve the administrative process of the clinical trial scheme. The online CTN form will reduce the burden of managing a paper based system as users will be able to generate invoices and make payments online, directly amend/vary information which have been submitted and manage or track submissions that have been made. The online sponsor declaration also now replaces the need for original signatures from Principal Investigator, Approval Authority and Human Research Ethics Committee, making the process much simpler.
For more information, please visit http://www.tga.gov.au/media-release/clinical-trials-new-online-form-ctn-scheme