TGA presentation: Coordinating Office for Clinical Trial Research Annual Workshop, 3 May 2017

Using the online Clinical Trial Notification (CTN) form

26 May 2017

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Presentation

  • 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

Transcript

Slide 1 - 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

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:
    • Medicines
    • Devices
    • Biologicals

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

Screenshot of TGA Business Services login screen

Slide 5 - This is your business portal

Screenshot of TGA Business Services Portal. Showing where to click through to 'Work on drafts' or 'View submissions'

Slide 6 - This is your online portal

Screenshot of TGA Business Services Online Portal showing navigation items for Clinical Trials and Online Invoice Payment

Slide 7

Screenshot of TGA CTN form: Trial Details

Slide 8

Screenshot of TGA Business Services Portal: Navigation area for Clinical Trial Notification Submission

Slide 9

Screenshot of TGA Clinical Trials Submissions form

Slide 10

Screenshot of TGA Clinical Trials Submissions form highlighting 'Should this application incur a fee, a copy of the invoice will be emailed to you and to the billing contact for the client

Slide 11

Screenshot of TGA Clinical Trials Submissions form payment screen highlighting the invoice number field

Slide 12 - Payment where no invoice is generated

Screenshot of TGA Clinical Trials Submissions form: Online payment highlighting Protocol No. and Site Name

Slide 13

Clinical Trials Repository

Slide 14

Clinical Trial Repository submission details

Slide 15

CTN Scheme and NIH Clin Regs website

Slide 16

If you need to submit an SUSAR report for a clinical trial, you can do so through the TGA Business Services (TBS) ADR Submission portal

 

This information can be found on the TGA website http://www.tga.gov.au/changes-submission-adr-repor...

Slide 17 - Any comments or questions?

Enquiries: clinical.trials@tga.gov.au

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