TGA presentation: Coordinating Office for Clinical Trial Research Annual Workshop, 3 May 2017
Using the online Clinical Trial Notification (CTN) form
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- Presented by: Veronica Scola, Experimental Products Section, Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration
- Presented at: Coordinating Office for Clinical Trial Research Annual Workshop
- Presentation date: 3 May 2017
- Presentation summary: To demonstrate the process for submitting an online Clinical Trial Notification (CTN) form
Slide 1 - Overview
- Submitting your CTN
- Problems that may be encountered with the Online CTN Form
- Invoices and Payments
- Acknowledgment Letters
- Website and Guidance
- Safety Reporting
Slide 2 - 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:
Slide 3 - 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 relevant element Variations required submission of all information again on paper with relevant signatures Online invoices for initial CTN. Online payment portal. ***No invoice for variations No invoice generated prior to payment. Online Payment portal
Slide 4 - Access to the online CTN Form
Slide 5 - This is your business portal
Slide 6 - This is your online portal
Slide 12 - Payment where no invoice is generated
This information can be found on the TGA website http://www.tga.gov.au/changes-submission-adr-repor...
Slide 17 - Any comments or questions?
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