Online Clinical Trial Notification (CTN) Kate Lawrence Pharmacist, Experimental Products Pharmacovigilance & Special Access Branch Medicines Regulation Division, TGA November 2015
Overview • Presentation objectives • Background • Data migration – Completion advices – Data re-formatting – Transition form – Posting data • 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 for: –Migration period –CTN frequently asked questions –Payments of CTN fees 2
CTN – Clinical Trial Notification CTX – Clinical Trial Exemption Background - CTN vs CTX Schemes 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 May conduct any number of clinical trials , valid notification and fee paid provided use of the product falls within the original approved Usage Guidelines Each additional trial site notified before Each trial must be notified to the TGA commencing trial at that site 3
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) 4
Characteristics of Online & Paper based CTN Online Paper based Online sponsor declaration Four signatures required - no signatures required M anage and track CTN’s via the TGA Track CTNs via paper files Business Services (TBS) dashboard Vary trials electronically Variations done on paper with relevant signatures Online invoices and payment portal No invoice generated prior to payment 5
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 – clinical.trials@tga.gov.au 6
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 Posting to Data Post- paper-based online TBS reformatting migration database system 7
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 Posting to Data Post- paper-based online TBS reformatting migration database system 8
Data migration – variations during data re-formatting • Sponsors can vary CTNs during the re-formatting period by: § Using the paper transition CTN form Or § 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 Posting to Data Post- paper-based online TBS reformatting migration database system 9
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 10
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- Data Posting to online Post- based database reformatting TBS system migration 11
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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- Data Posting to online Post- based database reformatting TBS system migration 13
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 Posting to Closing of paper- Data online TBS Post-migration based database reformatting system 14
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. 15
Clinical trial FAQs What 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. 16
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. – 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. 17
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 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. 18
Clinical trial payments • Payments can be made via: – TBS finance portal – Credit card – Cheque – EFT transfers https://www.tga.gov.au/payment-options 19
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 20 pay
Future Improvements • Acknowledgment Letters – Auto Notification § Request for information under Section 31 • Mandatory Fields – Renaming fields – Decreasing fields • Payment system for CTN variations 21
Any comments or questions? Enquiries: clinical.trials@tga.gov.au 22
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