Pierre-Frédéric Omnes’ Post

Launch of revised transparency rules in CTIS (re) confirmed for 18 June 2024 Update from EMA on April 22nd via the ACT EU hopepage and email communications, the revised CTIS (Clinical Trial Information System) transparency rules will indeed come into effect on 18 June 2024 (as originally communicated) with the launch of a new version of the CTIS website (public portal). As a reminder, the implementation of the new transparency rules in the CTIS Sponsor workspace (decommissioning of the deferral functionality, alignment of the system functionalities with the new publication rules effectively limiting the documents to be made public) goes along with the launch of the public portal allowing the enhanced access to the published information coming from trials approved under the CTR since its go live via CTIS. This implementation will also simplify the compilation of clinical trial applications (initial, transition, modifications, additional member states) with less documents to redact following this implementation of the new transparency rules in CTIS. More to come in the following weeks ! EMA news (on ACT EU home page): https://lnkd.in/eA5gUnFK Quick guide for users on new transparency rules (updated 22 April 2024): https://lnkd.in/ezREF42e #EUCTR #CTIS #PurposefulTransparency

Launch of revised transparency rules in CTIS Update from the EU Commission on April 11th, the revised CTIS (Clinical Trial Information System) transparency rules will come into effect on 18 June 2024, with the launch of a new version of the CTIS website (public portal). As a reminder, the implementation of the new transparency rules in the CTIS Sponsor workspace (decommissioning of the deferral functionality, alignment of the system functionalities with the new publication rules effectively limiting the documents to be made public) goes along with the launch of the public portal allowing the enhanced access to the published information coming from trials approved under the CTR since its go live via CTIS. This implementation will also simplify the compilation of clinical trial applications (initial, transition, modifications, additional member states) with less documents to redact following this implementation of the new transparency rules in CTIS. More to come in the following weeks ! EU Commission news: https://lnkd.in/edShTX35 Quick guide for users on new transparency rules: https://lnkd.in/ezREF42e #EUCTR #CTIS #PurposefulTransparency

EUCTR / CTIS March 2024 updates Very busy end of quarter with yet again new / updated CTR & CTIS guidance: - A new CTCG Best Practice Guide for sponsors – first substantial modification (SM) Part I after CTR transition (version 1, dated 19Mar2024) and its 2 annexes (cover letter template, SM template for first SM post transition) providing further guidance on which documents to update in relation to the post transition SM, and supportive templates for compiling that SM Guidance document: https://lnkd.in/dDAnQrNJ cover letter template: https://lnkd.in/duh84k2k SM template: https://lnkd.in/dd8PmXNR - A new recommendation paper on principles of Good Laboratory Practices for clinical trial applications under CTR, issued by CTCG together with relevant EMA and EC working groups and parties (version 1, March 2024) and an accompanying template table. This document is also mentioned in the latest version of the CTR Transition Q&A, updated earlier this month by the EU Commission, and provides considerations on the requirements regarding OECD GLP compliance (and regulatory acceptability) of pivotal non-clinical data submitted to support a clinical trial application submitted in the EU for sponsors, test facilities, and other interested parties. Recommendation paper: https://lnkd.in/dfwr9JFq Template table: https://lnkd.in/dq_cKeVu - An updated CTCG Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014 (now version 4, dated March 2024) and its corresponding cover letter template, with further clarifications on low intervention clinical trials, auxilliary medicinal products and managing archiving rules when transition trials include countries ended under CTD and ongoing / transitioned to CTR. Guidance: https://lnkd.in/d5X9-4uD cover letter template: https://lnkd.in/dJ6JX8Mj #EUCTR #CTIS #CTRTransitions

EUCTR / CTIS February (and early March) 2024 updates - An updated version of the Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation (now version 3 dated March 2024), aligning the content of the document with the latest CTCG guidance on transitions and including a statement on consequences of non-compliance with transition obligations ("sponsors may be subject to corrective measures by Member States pursuant to Article 77 of the CTR") and introducing a new Annex I (Overview of requirements dossier part II for a transitioning CT application in the first administrative transition step) https://lnkd.in/eJGezNkH - An updated version of the CTR Q&A (now version 6.8 dated March 2024) including some changes to questions 1.17 (What is considered to be an auxilliary medicinal product) in line with updated Auxiliary Medicinal Products guidance, 1.19 (which principles of good laboratory practice need to be taken into account for the authorization of clinical trials) quoting an upcoming CTCG recommendation paper on GLP, 2.15 (IMPD-Q only procedure) and Annex III (updates for Belgium and Denmark) https://lnkd.in/ec9Gt4aV - An updated version of the guidance on Auxiliary Medicinal Products in clinical trials (now dated March 2024, despite the old version still appearing on EudraLex volume 10 at the moment) including minor editorial changes to the documentation required for placebos as pre-medication (section 3.2), changes to the documentation required for unmodified authorized AxMPs (section 3.3), changes to Annex 1 (challenge agents, background treatments) and addition of a new Annex 2 with flowchart on labelling requirements https://lnkd.in/eEXZfAuy - An updated version of the quick guide for sponsors "Regulation 536/2014 in practice" (now version 5 dated March 2024) aligning Annex 1 (Composition of the clinical trial application in CTIS) with the CTCG best practice guide naming of documents in CTIS https://lnkd.in/eG7Tp9AK

Looking forward to see you at the EUCROF conference in Prague next week.

EUCTR / CTIS January 2024 updates - An updated version of the Q&A on the protection of Commercially Confidential Information and Personal Data while using CTIS (now version 1.4, dated 31Jan2024) has been publised on the ACT EU page. A new question has been included to provide clarifications on patient facing documents disclosure "3.4 Is it possible not to disclose patient facing documents publicly? In some cases, written agreements between the sponsor and the third-party service provider expressly establish that patient facing documents (e.g. patient questionnaires) cannot be disclosed publicly. In those cases, it is possible for the sponsor to upload in the ‘for publication’ placeholder a document where a justification for not disclosing the patient facing document is provided. In the placeholder ‘not for publication’ the document with its full content should be uploaded to allow the Member State(s) assessment." The updated Q&A is available here: https://lnkd.in/efuziRmM - Note on 2 year-anniversary of the CTR go live, and transitions: 31 January 2024 also marks two years since the application of the Clinical Trials Regulation (CTR) and the launch of the Clinical Trials Information System (CTIS). By end 2023, over 3,300 initial applications have been submitted in CTIS (over 1,900 authorised). Remember that the three-year transition period ends on 30 January 2025 therefore it becomes urgent to transition trials that may still ongoing by 30 January 2025 from the Clinical Trials Directive to the CTR at your earliest convenience. Considering that despite the accelerated transition assessment currently in place, certain Member State can take up to 3 months to provide their decision on the initial application, October is the deadline to complete your initial transition application safely. Anything later then places a risk of non compliance in case member state decisions are not in place by 30Jan2025 for your impacted clinical trials. #EUCTR #CTIS #PurposefulTransparency #CTRTransitions

With less than a year now to complete initial transition applications and guidance evolving regularly, take this opportunity to get insight on best practices and opportunities to manage your upcoming transitions. Aso taking this opportunity to with you a happy (transition) year.

EUCTR / CTIS December 2023 updates - EUCTR Q&A (EudraLex Volume 10) updated to Version 6.7 (December 2023) introduces some clarifications in Chapter 7 (Safety): inpatient hospitalization definition (Question 7.2), Reference safety information (Questions 7.11 and 7.13) and Annual safety Reports (questions 7.34, 7.41 and 7.51). Annexes have also been revised (Annex II for Portugal and Estonia, Annex 3 for Hungary, Finland and Sweden) https://lnkd.in/e7e6UUbS - Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation (EudraLex Volume 10) now version 2 (December 2023) has been updated in relation to new transparency requirements (Question 11, note specific instructions for category 1 trials) https://lnkd.in/ez2JrMeS - The CTR summary document available on EudraLex Volume 10 entitled 'Clinical Trials Regulation (EU) No 536/2014 in practice' now version 4 (08 December 2023) has been udpated on Transparency (Chapter 5, interim period until the technical implementation of the revised transparency rules into CTIS) and ATMPs (Chapter 6.1, administration and notification of out of specification product of an ATMP) - A list of the official public holidays in European countries for 2024, as recorded in the Clinical Trials Information System (CTIS), has been published on the EMA website. https://lnkd.in/e-Kf_ZBa As a reminder, all timers regarding evaluation of a clinical trial application have stopped on 22 December 2023 at 23:59:59 CET and resume on 8 January 2024 at 00:00:01 CET (CTIS winter clock stop) Best wishes for a successful EUCTR 2024 transition year and much more. #EUCTR #CTIS

EUCTR / CTIS November 2023 updates - The Q&A on the protection of commercially confidential information and personal data while using CTIS has been updated to version 1.3 (dated 29 November 2023) and includes updates pertaining to the new transparency rules released earlier this year and their implementation in CTIS. The Q&A has been updated in line with those new rules. This document (along with the transparency guidance documents) is available on the ACT EU website https://lnkd.in/efuziRmM - The CTCG Best Practice Guide on transition trials has been updated to Version 3 (adopted at the CTCG plenary November 13 2023) and published on 28 November 2023. This update includes clarifications on consolidated protocols, background treatment and Consolidation of Investigator’s brochures (IB) and/or Investigational Medicinal Product Dossier (IMPD) not previously harmonized under CTD. https://lnkd.in/epuGvK2x The Transition application cover letter template has also been updated: https://lnkd.in/ewiR8ZKk - The CTIS sponsor handbook has been updated to version 3.03 (dated 10 November 2023) with a few updates pertaining to sections 2.2.3 (Module 7 video links) and section 4.2 (Part II documents and additional reference materials for CTIS users link). https://lnkd.in/e4JGjnFn #EUCTR #CTIS