Online Clinical Trial Notification (CTN) Mounir Mina Director, - PowerPoint PPT Presentation

Online Clinical Trial Notification (CTN) Mounir Mina Director, Experimental Products Section Pharmacovigilance & Special Access Branch Medicines Regulation Division, TGA 2017 ARCS Annual Conference August 2017

Overview • Background • Updates to safety reporting • Updates to the CTN online form – Fee engine – Data migration – Print preview • Update to clinical trials guidance documents • Update to clinical trials website 1

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 or CTX is required for supply of any ‘unapproved’ therapeutic good in a clinical trial 2

Legislative and regulatory framework for the clinical trial schemes Therapeutic Act/Regulation CTN CTX good type Therapeutic Goods Act 1989 Section 18 (1) Section 19 (1) (b), 19 (1A)- 19(4A) Medicines Therapeutic Goods Regulations 1990 Regulation 12 (2)-Schedule 5A Regulation 12AA, 12AB, 12AC, Item 3, 12 AD 12AD Therapeutic Goods Act 1989 Section 41HA(1) Section 41HB(1) Devices Therapeutic Goods (Medical Regulation 7.1, Schedule 4, Regulation 7.3, 7.4 and 7.5 Devices) Regulations 2002 Item 2.3 Therapeutic Goods Act 1989 Section 32CA(2) Section 32CK(1), 32CL Biologicals Therapeutic Goods Regulations 1990 Regulation 12(2)-Schedule 5A, Regulation 12AA, 12AB, 12AC, Item 3 12AD 3

CTN vs CTX Schemes CTN – Clinical Trial Notification CTX – Clinical Trial Exemption Two step approval process – part 1 (approval) part 2 Notification process (notification) Medicines, devices or biologicals but required for Medicines, devices or biologicals certain class 4 biologicals No TGA review of data prior to trial TGA evaluates the proposed Usage Guidelines May conduct any number of clinical trials , provided Supply of goods cannot commence without valid use of the product falls within the original approved notification and fee paid Usage Guidelines Each additional trial site notified before commencing Each trial must be notified to the TGA trial at that site 4

Response to stakeholder feedback • Stakeholder feedback has guided updated to the CTN/CTX schemes • Changes are being made to: – Safety reporting methods – Fee engine – Data migration – Printing TGA acknowledgement – Guidance documents – Website • We encourage stakeholders to continue to provide feedback to us 5

Safety reporting • Updates regarding how to submit safety documentation to the TGA available on our website. • If you need to submit an SUSAR report for a clinical trial, you can do so via: – the TGA Business Services (TBS) ADR submission portal – by email using a Blue Card or CIOMS form to adr.reports@tga.gov.au – E2B reports should be emailed to e2b.reports@tga.gov.au • NHMRC has published the guidance document: – Safety monitoring and reporting in clinical trials involving therapeutic goods – Addresses adverse event reporting for clinical trials conducted under the CTN/CTX schemes 6

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Updates to the online CTN form • Fee engine • Migration completed • Print preview 8

Fee engine • Fee engine enabled for addition of sites to previously notified clinical trials • Automatically generates an invoice after 90 minutes • Advice on paying with or without an invoice on TGA website FAQs 9

Payment where no invoice is generated 11

Data migration completed • Data migration processes have been completed by the TGA • Sponsors encouraged to update “Please Update” and or “N/A” fields in migrated trials • No fee applies for updating these fields unless accompanied by an addition of a new good or additional clinical trial site not previously notified Closing of Posting to Data Post- paper-based online TBS reformatting migration database system 12

Print preview • From March 1 2017 the TGA will no longer send acknowledgement letters via email • This information can be viewed and printed via the online portal • Instructions available on the TGA website • Printouts obtained from the Clinical Trials Repository will display ‘Acknowledged by TGA’ 13

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Update to clinical trials guidance documents • Proposed combining of 3 current guidance documents: – Access to Unapproved Therapeutic Goods: Clinical Trials in Australia – The Australian Clinical Trial Handbook – Human Research Ethics Committees and the Therapeutic Goods Legislation • Will aim to provide guidance on legislative, regulatory and good clinical practice (GCP) requirements for clinical trials involving the use of ‘unapproved’ therapeutic goods conducted in Australia • We value any input on the content of these guidance documents 15

Update to clinical trials website • Proposed updates to clinical trials websites to include: – Simplified content – User-friendly interface – CTN form online guidance to be consolidated into one document (html and pdf formats) – Guidance videos to assist sponsors to use the online form 16

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Instructional videos • Provide guidance in an engaging manner • To develop 2 videos relating to the use of the online CTN form • Topics based on sponsor feedback 18

For more information Email: clinical.trials@health.gov.au Visit: www.tga.gov.au/clinical-trials 19