Online Clinical Trial Notification (CTN) Adelina Tan Director, - - PowerPoint PPT Presentation

Online Clinical Trial Notification (CTN)

Adelina Tan Director, Experimental Products Section Pharmacovigilance & Special Access Branch Medicines Regulation Division, TGA May 2016

Overview

• Presentation objectives
• Background
• Data migration

– Completion advices – Data re-formatting – Variations – Posting data – Progress so far – Post migration

• Clinical trials FAQs
• Review of clinical trial payments

1

Presentation objectives

• Opportunity to provide comments regarding:

– Clinical Trial Notification (CTN) guidance – Future CTN improvements

• Provide explanation of:

– Migration period – CTN frequently asked questions – Payment of CTN fees

2

CTN – Clinical Trial Notification CTX – Clinical Trial Exemption

Notification process Two step approval process – part 1 (approval) part 2 (notification) Medicines, devices or biologicals Medicines, devices or biologicals but required for certain class 4 biologicals No TGA review of data prior to trial TGA evaluates the proposed Usage Guidelines Supply of goods cannot commence without valid notification and fee paid May conduct any number of clinical trials, provided use of the product falls within the

• riginal approved Usage Guidelines

Each additional trial site notified before commencing trial at that site Each trial must be notified to the TGA

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Background - TGA’s role differs from other regulators

• Exemption provided for supply of 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

• CTN or CTX required for supply of any unapproved good in a clinical trial

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Online vs paper based CTN

Online Paper based Online sponsor declaration

• no signatures required

Four signatures required Manage and track CTNs via the TGA Business Services (TBS) dashboard Track CTNs via paper files Vary trials electronically Variations done on paper with relevant signatures Online invoices and payment portal No invoice generated prior to payment

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Online form update

• Technical issues we have worked to address:

– Individual CTN technical problems

• Case by case resolution

– Payment system for CTN variations – Print preview & enhancement – CTN variations losing information

• Please contact us if you are experiencing a

technical issue

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Data migration – key information

• Internal paper CTN database closed on 19 October 2015

– Paper clinical trial completion advices are no longer accepted – Complete clinical trials online via the ‘Completion’ tab

Closing of paper-based database Data reformatting Posting to

• nline TBS

system Post- migration

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Data migration – re-formatting completed

• The TGA re-formatted data from the old paper-based database to match data

fields to the new online form

• During the data re-formatting period, the TGA was able to include changes

notified using the Transition Form and these are reflected in the online system

Closing of paper-based database Data reformatting Posting to

• nline TBS

system Post- migration

8

Data migration – posting data

• In December 2015 the TGA began posting CTN data from pre-1 July 2015 CTN

forms once individual sponsors had confirmed their TBS Client ID and list of trials to migrate

• The TGA posted data to the online system based on matching client IDs. Thus it is

important that sponsors who have changed Client ID notify the clinical trials team via email of any such changes Closing of paper-based database Data reformatting Posting to

• nline TBS

system Post- migration

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Data migration – posting data

• Once your CTN information is posted to the TBS system you are then be able to

view and vary CTN information yourselves using the ‘Change to trial details’ tab in TBS

• TGA will update the TGA website advising when the overall migration is complete
• The Transition Form will no longer be available once data migration has been

completed Closing of paper-based database Data reformatting Posting to

• nline TBS

system Post- migration

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Data migration – the progress so far

• As of 29 March 2016, the TGA had migrated approximately 67% of previously

notified clinical trials to the new online system and closed 142 as per sponsor requests

• The TGA anticipates that migration of previously notified trials will be complete by

30 June 2016

• All trials that have not been migrated will be archived by the TGA. However, these

will still be available on request Closing of paper-based database Data reformatting Posting to

• nline TBS

system Post- migration

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Data migration – You need to…

• 1. Ensure that your organisation has online access to TGA Business Services (TBS) and

does not have duplicate TGA client IDs

• 2. Nominate an administrator and update organisation details via the Organisation

details form. Ensure all users have appropriate system user roles and access

• 3. Email administrator contact details to the clinical trials team-

clinical.trials@tga.gov.au

Closing of paper-based database Data reformatting Posting to

• nline TBS

system Post- migration

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Data migration – to ensure trials are migrated

• 4. The clinical trials team will contact the administrator and provide a list of trials to be

migrated to your organisation’s online portal

• 5. The administrator should then reply to the clinical trials team to confirm the
• rganisation’s client ID and the list of trials to be migrated. Please note your

communication may request closure of any inactive trials if necessary

• 6. The clinical trials team will then post the trials to the TBS system or close the trials
• 7. Once the CTN information is posted to the TBS system you will receive an email from

the clinical trials team and will then be able to view and vary CTN information in the TBS system

Closing of paper-based database Data reformatting Posting to

• nline TBS

system Post- migration

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Data migration – post migration

• Sponsors need to update “Please Update” and or “N/A” fields for medicines, devices
• r biological sub-forms once previously notified CTNs have been migrated

– This is to prepare for fees becoming automated – Currently no fee applies for updating these fields unless accompanied by an addition of a new good or additional clinical trial site not previously notified

• Sponsors may also wish to review the address fields and contacts for HREC,

Approving Authority and Principal Investigator

Closing of paper-based database Data reformatting Posting to

• nline TBS

system Post- migration

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Clinical trial FAQs

Can a sponsor submit a CTN prior to receiving 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

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Clinical trial FAQs

What clinical trial documents are submitted to the Human Research Ethics Committee (HREC)?

• Individual HRECs decide which documents to view/consider prior to providing

approval

• TGA is amending the print preview function to allow draft documents to be

presented to HRECs if required

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Clinical trial FAQs

How do I vary a trial?

• Variations may include:

– Addition of site(s) / changing a previously notified site address – Addition of new therapeutic goods / change to previously notified goods – Updating principal investigator

• To vary the details of a submitted (and acknowledged) CTN, select Your TGA

Information then select Clinical Trials Repository on the Portal menu.

• Select the CTN you want to vary, then select Vary.
• The CTN you want to vary will then open, and you can make your change.

– You do not need to submit a new CTN

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Clinical trial FAQs

• A variation to a trial (i.e. additional site) is considered notified as soon as the

requirements set out under Item 3 of Schedule 5A of the Therapeutic Goods Regulations 1990 (the Regulations) have been met: – Submission of the online CTN form & – Payment of the relevant fee

• Currently $335

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Clinical trial FAQs

When do I advise the TGA of a completed clinical trial?

• The completion advice should be submitted to the TGA once the clinical trial

related activity afforded by this exemption is complete and thus the exemption would no longer be required – It is up to the sponsor to determine when the exemption is no longer required

• It is not necessary to notify completion dates for individual trial sites

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Clinical trial FAQs

What are the labelling requirements for Investigational Medicinal Products (IMP) in clinical trials?

• The TGA has adopted the PIC/s Guide for Good Manufacturing Practice for

Medicinal Products 2009, with Annex 13 of this guide referring to the manufacture

• f investigational medicinal products

– Labelling requirements under items 26-33 – This document is available on the TGA website: www.tga.gov.au/publication/manufacturing-principles-medicinal-products

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Clinical trial payments

• Payments can be made via:

– TBS finance portal – Credit card – Cheque – EFT transfers www.tga.gov.au/payment-options

21

Clinical trial payments

• For all payments (except TBS finance

portal) please include the following information as requested: – Client ID – Protocol number & site name

• No invoices automatically generated for

variations to CTNs until the variation fee engine is implemented

22

Future improvements

• Assisting sponsors to complete the form
• Amendments to the CTN form

– Continually updating online form – Renaming fields

• Presentation  type of container
• Payment system for CTN variations

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For more information

Email: clinical.trials@tga.gov.au Visit: www.tga.gov.au/clinical-trials

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