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 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 • 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 4
Online vs paper based CTN Online Paper based Online sponsor declaration Four signatures required - no signatures required Manage and track CTNs 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
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 6
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 Posting to Data Post- paper-based online TBS reformatting migration database system 7
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 Posting to Data Post- paper-based online TBS reformatting migration database system 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 Posting to Data Post- paper-based online TBS reformatting migration database system 9
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 Posting to Data Post- paper-based online TBS reformatting migration database system 10
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 Posting to Data Post- paper-based online TBS reformatting migration database system 11
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 Posting to Data Post- paper-based online TBS reformatting migration database system 12
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 organisation’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 Posting to Data Post- paper-based online TBS reformatting migration database system 13
Data migration – post migration • Sponsors need to update “Please Update” and or “N/A” fields for medicines, devices or 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 Posting to Data Post- paper-based online TBS reformatting migration database 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 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 16
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 17
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 18
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 19
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: www.tga.gov.au/publication/manufacturing-principles-medicinal-products 20
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