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Presentation

• Presented by: Mounir Mina, Experimental Products Section, Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration
• Presented at: Victorian Department of Health and Human Services
• Presentation date: 24 November 2016
• Presentation summary: This presentation provides a brief background on the TGA's role in the regulation of clinical trials as well as guidance on using the new online Clinical Trial Notification form

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Online Clinical Trial Notification (CTN)

Mounir Mina
Director, Experimental Products Section
Pharmacovigilance & Special Access Branch
Medicines Regulation Division, TGA

24 November 2016

• Background
• How to Access the Online Form
• Guidance on using the new Online CTN form
• Clinical trials FAQs

Slide 2 - Background - TGA’s role differs from other regulators

• Exemption provided for unapproved therapeutic goods rather than end-to-end regulation of trials
  • CTN – Section 18(1) of the Therapeutic Goods Act 1989
  • CTX – Section 19(1)(b) of the Therapeutic Goods Act 1989
• Biologicals
  • CTN – Section 32CA(2) of the Act, Regulation 12(2) – Schedule 5A, Item 3
  • CTX – Section 32CK(1), 32CL of the Act, Regulation 12AA, 12AB, 12AC, 32AD
• CTN or CTX required for supply of any unapproved good in a clinical trial

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 - Where are we up to in the implementation.

• Data from clinical trials will be moved into the relevant fields in TBS
  • From 7 December 2015
    • Sponsors to review CTN information/Confirm Migration/Active or Closed
  • By 29 September 2016
• 77.6% of trials Migrated and 335 closed

Closing of paper-based database → Data reformatting → Posting to online TBS system → Post-migration

Slide 5 - Submission of notification via Online Form

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Slide 13 - Sponsor Declaration

• Online sponsor declaration states in regards to ethics approvals:
  1. the approval of the goods for the trial has been given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee responsible for monitoring the conduct of the trial, on terms no less restrictive than terms advised by that committee
  2. the sponsor has not received advice from the ethics committee that is inconsistent with the continuation of the trial
  3. the requirements in regulation 12AD of the Therapeutic Goods Regulations 1990 (in the case of therapeutic goods other than medical devices) and regulation 7.5 of the Therapeutic Goods (Medical Devices) Regulations 2002 (in the case of medical devices) are complied with, including that the use of therapeutic goods in the trial must be in accordance with the Guidelines for Good Clinical Practice and the National Statement on the Ethical Conduct in Research Involving Humans published by the National Health and Medical Research Council, as defined in the Therapeutic Goods Regulations

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Slide 18 - Online Form Guidance Documents

Slide 19 - Clinical trial FAQs

How is the CTN process interlinked with Human Research Ethics Committee (HREC) approval?

• As defined in the Regulations, the clinical trial sponsor must acknowledge that the goods only remain exempt so long as:
  • appropriate advice has been received from HREC
  • the trial is conducted in accordance with the:
    • Guidelines for Good Clinical Practice
    • National Statement on the Ethical Conduct in Research involving Humans (published by the National Health and Medical Research Council).
• This is also stated in the online sponsor declaration accepted prior to submitting the CTN.
• TGA has amended the print preview function to allow documents to be printed at the draft submission or finalised notification stage.

Slide 20 - Any comments or questions?

Enquiries: clinical.trials@tga.gov.au

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• Presentation: Online Clinical Trial Notification (CTN) (1.45,mb)