Using the online Clinical Trial Notification (CTN) form Veronica - PowerPoint PPT Presentation

Using the online Clinical Trial Notification (CTN) form Veronica Scola Pharmacist Experimental Products Section Pharmacovigilance & Special Access Branch Medicines Regulation Division, TGA May 2017

Overview • Background • Submitting your CTN • Problems that may be encountered with the Online CTN Form • Updates – Invoices and Payments – Acknowledgment Letters – Website and Guidance – Safety Reporting

Background – TGA’s role differs from other regulators • An exemption is provided for unapproved therapeutic goods rather than the TGA undertaking end-to-end regulation of trials • A Clinical Trial Notification ( CTN ) or Clinical Trail Exemption ( CTX ) is required for supply of any unapproved good in a clinical trial. • An unapproved therapeutic good includes: – Medicines – Devices – Biologicals

Online vs paper-based CTN – Sponsor requirements Online Paper-based Online sponsor declaration Four signatures required (HREC, Principal - no signatures required Investigator, Approving Authority, Sponsor) Manage and track CTN’s via the TGA Track CTNs via paper files Business Services (TBS) dashboard Vary trials electronically, change only the Variations required submission of all relevant details information again on paper with relevant signatures Online invoices for initial CTN. No invoice generated prior to payment. Online payment site Online Payment site ***No invoice for variations that incur a fee

Access to the online CTN Form

This is your Business Portal 5

This is your Online Portal

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Payment where no invoice is generated 12

Any comments or questions? Enquiries: clinical.trials@health.gov.au