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

• no signatures required

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

Access to the online CTN Form

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This is your Business Portal

This is your Online Portal

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Payment where no invoice is generated

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Any comments or questions?

Enquiries: clinical.trials@health.gov.au