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Online Clinical Trial Notification (CTN)
Kate LawrencePharmacist, Experimental ProductsPharmacovigilance & Special Access BranchMedicines Regulation Division, TGA
November 2015
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Overview• Presentation objectives• Background • Data migration
– Completion advices– Data re-formatting– Transition form– Posting data
• Clinical trials FAQs• Review of clinical trial payments
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Presentation objectives
• Opportunity to provide comments regarding:–Clinical Trial Notification (CTN) guidance –Future CTN improvements
• Provide explanation for:–Migration period–CTN frequently asked questions–Payments of CTN fees
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Background - CTN vs CTX SchemesCTN – 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 original 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
• Clinical trial exemptions provided for the 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– Decision of whether a CTN or CTX is required lies with sponsor in consultation
with Human Research Ethics Committee (HREC)
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Characteristics of Online & Paper based CTNOnline Paper basedOnline sponsor declaration - no signatures required
Four signatures required
Manage and track CTN’s 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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Current information on the online form• Initial technical issues with the form
– Affecting some users or all users For example information ‘dropping off’ CTN variations
• TGA currently updating:– Payment system for CTN variations
Sponsors can generate online invoices in the TBS portal for CTN variations– Print preview function
• Please contact us if you are experiencing a technical issue– [email protected]
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Data migration – completion advices
• TGA moved from paper CTN database to online database on 1 July 2015• Internal paper CTN database closed on 19 October 2015
– Completion advices can now only be submitted to TGA via the online CTN form– TGA will not be able to process paper clinical trial completion advices however
we can ‘post’ the CTN to the clinical trials repository for you to complete
Closing of paper-based
database
Data reformatting
Posting to online TBS
system
Post-migration
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Data migration –data re-formatting
• Data reformatting involves electronic and manual movement of data to relevant fields in TBS– TGA staff manually moving some CTN information to TBS fields
i.e. strength and active ingredient
Closing of paper-based
database
Data reformatting
Posting to online TBS
system
Post-migration
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Data migration – variations during data re-formatting
• Sponsors can vary CTNs during the re-formatting period by: Using the paper transition CTN formOr Advising TGA whether the client ID needs to be changed for the trial. TGA will
then migrate the trial to TBS system after 7 December.• Changes then occurs online via ‘Variation’ tab
Closing of paper-based
database
Data reformatting
Posting to online TBS
system
Post-migration
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Data migration – variations to clinical trials
The variation to the 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 for medicines and medical devices
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Data migration – Posting data • Once CTN information reformatted data posted to online TBS system
– From 7 December 2015 Each sponsor needs a TBS administrator TGA to contact the sponsor’s TBS administrator for each Client ID with a list of
open CTNs The sponsor’s TBS administrator for that Client ID to advise TGA whether trials
need to change Client ID• No trials will migrate until TGA advised
Trials will appear in the clinical trials repository
Closing of paper-based database
Data reformatting
Posting to online TBS system
Post-migration
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Portfolio view of associated clinical trials (default)
Single view of clinical trial (optional)
Transitioning to TBS platform
Organisation, Institution or Sponsor
Trial 1 Trial 2 Trial 3 Trial 4
Organisation, Institution or Sponsor
Trial 1 Trial 2 Trial 3 Trial 4
Trial 1Alternative
option for users
Paper CTN
Trial 2 Trial 3 Trial 4
A view from TBS
Conceptual view: A view from TBS
Conceptual view:Conceptual view:
Work in progress
Drafts Submissions
Date Identifier Client reference Information Sponsor
20 November 2015
CT-2015-CTN-03058-1-v1
Clinical Trial Test 1 –Department B
TGA E business account for application processing
CT-2015-CTN-03059-1-v1
Clinical Trial Test 2 –Department A
TGA E business account for application processing
CT-2015-CTN-03060-1-v1
Clinical Trial Test 3 –Department C
TGA E business account for application processing
CT-2015-CTN-03061-1-v1
Clinical Trial Test 4 –Department D
TGA E business account for application processing
View all drafts
20 November 2015
20 November 2015
20 November 2015
Work in progress
Drafts Submissions
Date Identifier Client reference Information Sponsor
CT-2015-CTN-03059-1-v1
Clinical Trial Test 2 –Department A
TGA E business account for application processing
View all drafts
20 November 2015
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Data migration – Posting data
• After data in TBS clinical trial repository– Variations made via the ‘Change to trial details tab’ in TBS– Transition form will not be available once your clinical trials have migrated to TBS
Closing of paper-based database
Data reformatting
Posting to online TBS system
Post-migration
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Data migration – Post migration• Sponsors please review CTN information to ensure migrated correctly from the
paper database to the online TBS form For data accuracy
Closing of paper-based database
Data reformatting
Posting to online TBS
systemPost-migration
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Clinical trial FAQsCan 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 FAQsWhat clinical trial documents are submitted to the Human Research Ethics Committee (HREC)?
• Individual HREC’s decision which documents to view/consider prior to providing approval.
• TGA is amending the print preview function to allow draft documents to be presented to HREC’s if required.
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Clinical trial FAQsWhen 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. – This would usually correspond with the last patient last visit (LPLV) however 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 FAQsWhat 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 of investigational medicinal products. – Labelling requirements under items 26-33.– This document is available on the TGA website: https://
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
https://www.tga.gov.au/payment-options
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Clinical trial payments• For all payments (except TBS finance
portal) please include the following information as requested:– Client ID– Protocol number & site name
• Payment system will be implemented for variations to CTN’s • Invoices for CTN variations can then be
generated online• No separate login/payment required to
pay
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Future Improvements • Acknowledgment Letters
– Auto Notification Request for information under Section 31
• Mandatory Fields– Renaming fields– Decreasing fields
• Payment system for CTN variations
