TGA Presentation: Using the online Clinical Trial Notification (CTN) form

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Presented by Veronica Scola from the TGA, at the Coordinating Office for Clinical Trial Research Annual Workshop, 3 May 2017.

Health & Medicine

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

Payment where no invoice is generated
12

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

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TGA Presentation: Using the online Clinical Trial Notification (CTN) form

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

2. 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

3. 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

4. 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

5. Access to the online CTN Form

6. 5 This is your Business Portal

7. This is your Online Portal

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13. Payment where no invoice is generated 12

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

TGA Presentation: Using the online Clinical Trial Notification (CTN) form

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