Presentation: Online Clinical Trial Notification (CTN)
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An overview of the online Clinical Trial Notification system, and updates to TGA guidance and supporting information for clinical trials.
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Presentation: Online Clinical Trial Notification (CTN)
- 1. 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
- 2. 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
- 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 or CTX is required for supply of any ‘unapproved’ therapeutic good in a clinical trial 2
- 4. Legislative and regulatory framework for the clinical trial schemes Therapeutic good type Act/Regulation CTN CTX Medicines Therapeutic Goods Act 1989 Section 18 (1) Section 19 (1) (b), 19 (1A)- 19(4A) Therapeutic Goods Regulations 1990 Regulation 12 (2)-Schedule 5A Item 3, 12 AD Regulation 12AA, 12AB, 12AC, 12AD Devices Therapeutic Goods Act 1989 Section 41HA(1) Section 41HB(1) Therapeutic Goods (Medical Devices) Regulations 2002 Regulation 7.1, Schedule 4, Item 2.3 Regulation 7.3, 7.4 and 7.5 Biologicals Therapeutic Goods Act 1989 Section 32CA(2) Section 32CK(1), 32CL Therapeutic Goods Regulations 1990 Regulation 12(2)-Schedule 5A, Item 3 Regulation 12AA, 12AB, 12AC, 12AD 3
- 5. CTN vs CTX Schemes 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 original approved Usage Guidelines Each additional trial site notified before commencing trial at that site Each trial must be notified to the TGA 4
- 6. 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
- 7. 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
- 8. 7
- 9. Updates to the online CTN form • Fee engine • Migration completed • Print preview 8
- 10. 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
- 12. Payment where no invoice is generated 11
- 13. 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 paper-based database Data reformatting Posting to online TBS system Post- migration 12
- 14. 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
- 15. 14
- 16. 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
- 17. 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
- 18. 17
- 19. 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
- 20. For more information Email: clinical.trials@health.gov.au Visit: www.tga.gov.au/clinical-trials 19
Editor's Notes
- The CTN is an exemption provided to unapproved goods under section 18(1) of the Therapeutic Goods Act. The exemption needs to be in place prior to the supply of unapproved therapeutic goods in a clinical trial setting. An ’unapproved’ therapeutic good includes: any medicine not entered on the ARTG, including any new formulation, strength or size, dosage form, name, indications, directions for use or type of container of a medicine already in the ARTG any medical device not entered in the ARTG, including any new design specification, model, technology, material or treatment modality of a medical device already in the ARTG any biological not entered in the ARTG: including any new applicable standards, intended clinical use or principal manufacturer of a Class 1 or 2 biological already in the ARTG including any new product name, dosage form, formulation or composition, therapeutic indication, type of container or principal manufacturer of a Class 3 or 4 biological already in the ARTG a therapeutic good already in the ARTG that is used beyond the conditions of its marketing approval including labelling
- Legislation applicable to the clinical trial schemes
- The decision of whether a trial should be submitted as a CTN or a CTX lies with the sponsor with input as needed from the HREC
- The TGA has worked on a number of updates to the CTN and CTX schemes based on stakeholder feedback We note your feedback and are currently making changes to the following: - Safety reporting methods - Fee engine - Data migration - Printing TGA acknowledgement - Guidance documents - Website We encourage our stakeholders to continue to inform the TGA of their experiences with the CTN and CTX schemes
- The TGA has updated its processes for receiving suspected unexpected serious adverse reaction (SUSAR) reports for medicines and biologicals used in clinical trials under the Clinical Trials Notification (CTN) or Clinical Trials exemption (CTX) schemes. If you need to submit an SUSAR report for a clinical trial, you can do so through the TGA Business Services (TBS) ADR submission portal or 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 a guidance document to clarify the responsibilities of all parties in relation to reports of adverse events (AE), including serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs), occurring in clinical trials for which institutions are responsible and for which the Human Research Ethics Committees (HRECs) have reviewed and approved. This guidance specifically addresses the monitoring, collection and reporting of adverse events and adverse reactions that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs) for trials conducted under the Clinical Trial Exemption (CTX) or Clinical Trial Notification (CTN) schemes.
- Access this information via safety information tab on the website
- At the request of our sponsors, the TGA has enabled the online form to produce an invoice for an addition of a site(s) to a previously notified clinical trial. Approximately 90 minutes after submitting the variation to add a site, the contact person listed on the CTN (as well as those with a finance role) will receive an automatically generated invoice. This invoice can be paid using the payment options outlined on the TGA website.
- We recommend that you wait for the invoice before making payment as this ensures that there are no delays in matching payment. Payment may be submitted through a range of options as described in our Payment options webpage. Payment through the online payment portal is the preferred option. The invoice number must be entered into relevant payment field.
- The TBS portal is currently unable to generate invoices for certain changes to an existing CTN, such as adding a new therapeutic good. You may still make payment for these variations using one of the TGAs payment options. Our preferred option is for you to make your payment via the online payment portal. You may select option 3 (for a trial involving a medicine), option 4 (for a trial involving a device) or option 5 (for a trial involving a biological) A CTN application ID and version number must be entered to assist in matching payment to a CTN.
- Data migration processes have been completed by the TGA. We encourage sponsors to update the “Please Update” and or “N/A” fields in migrated trials to ensure accurate data collection. There will be no charge for updating these fields unless accompanied by addition of a new good or additional clinical trial site not previously notified.
- Effective 1 March 2017 the TGA will no longer send acknowledgment letters by email as this information can now be viewed and printed via your online portal. Instructions on how to obtain these print-outs is available in the section 'Printing, deleting, and copying' of the guidance document Using the online CTN form. The TGA advises clinical trial sponsors to obtain and save a print-out of your notification at each stage of the submission process. Within the online portal, there are three different stages during the CTN submission process at which you can preview and print the submission: Drafts, Lodged Submissions and Clinical Trials Repository. Only those print-outs obtained from the Clinical Trials Repository serve as evidence that the clinical trial has been notified to the TGA. These print-outs will display the application ID, the submission date and the phrase 'Acknowledged by TGA' in the top of the document. The TGA is happy to work with any sponsors who experience any difficulties with the print preview function in the new online form.
- How to access the print preview button from the Repository
- We are working on combining and updating the following 3 guidance documents on the TGA website: Access to Unapproved Therapeutic Goods: Clinical Trials in Australia The Australian Clinical Trial Handbook Human Research Ethics Committees and the Therapeutic Goods Legislation This consolidated guidance 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.
- Based on stakeholder feedback, we are working on updating the clinical trials website. We hope this will assist stakeholders to find information regarding the CTN and CTX schemes. Proposed updates to clinical trials websites to include: Simplified content User-friendly interface with tabs for each scheme CTN form online guidance to be consolidated into one document (html and pdf formats). This is currently only available in html format. Guidance videos to assist sponsors to use the online form
- Sample of possible user interface for the new website
- Based on sponsor feedback, we are developing/have developed 2 videos relating to the use of the online CTN form. These videos will assist sponsors to submit an online form. The videos will also allow ethics committees and other stakeholders that do not have access to the online CTN form to visualise the steps involved in submitting a CTN.
- Invite attendees to email us requesting we add them to our contact lists.