{"id":24489,"date":"2025-07-09T14:30:58","date_gmt":"2025-07-09T12:30:58","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/non-categorizzato\/ctis-6-0-cambiano-le-regole-per-gli-sponsor-dei-trial-clinici\/"},"modified":"2025-08-01T15:20:36","modified_gmt":"2025-08-01T13:20:36","slug":"ctis-6-0-cambiano-le-regole-per-gli-sponsor-dei-trial-clinici","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/regulatory\/guidelines\/ctis-6-0-cambiano-le-regole-per-gli-sponsor-dei-trial-clinici\/","title":{"rendered":"CTIS\u20116.0. Changes to the rules for clinical trial sponsor"},"content":{"rendered":"

On July 9, 2025, the European Medicines Agency (EMA)<\/strong> published version 6.0 of the CTIS Sponsor Handbook, the official guide for the use of the Clinical Trial Information System (CTIS)<\/strong> by sponsors of clinical trials.<\/p>\n

Two years after the full implementation of Regulation (EU) 536\/2014<\/a>, the document has been completely updated \u2014 both in structure and content \u2014 with the aim of improving system usability and supporting a more efficient and transparent management of clinical trials in the EU\/EEA.<\/p>\n

Download the document<\/span><\/a><\/span><\/p>\n

A new version for a new phase<\/h2>\n

The first major change is the complete restructuring of the handbook \u2014 not just an update, but a full redesign of its overall framework, now organized around the clinical trial lifecycle. The interactive table of contents guides sponsors step by step, from the pre-submission phase through to the publication of results and trial closure, including authorizations, amendments, and notifications along the way.<\/p>\n

Among the most expanded sections:<\/p>\n

    \n
  • \n

    Pre-submission (access and registrations)<\/p>\n<\/li>\n

  • \n

    User role management<\/p>\n<\/li>\n

  • \n

    Notifications of events during study conduct<\/p>\n<\/li>\n

  • \n

    Submission of results and the Clinical Study Report (CSR)<\/strong><\/p>\n<\/li>\n<\/ul>\n

    User roles: greater clarity and control<\/h2>\n

    A key area addressed in the new handbook is the management of access and user roles within CTIS. The distinction between the two operational approaches is further clarified:<\/p>\n

      \n
    • \n

      Organisation-centric<\/strong>: recommended for structured sponsors and\/or those running multiple trials, this model allows centralized user management via one or more Sponsor Admins.<\/p>\n<\/li>\n

    • \n

      Trial-centric<\/strong>: designed for smaller or academic sponsors, this model enables the creation of individual trials by a CT Admin, but comes with limitations in terms of overall visibility and security.<\/p>\n<\/li>\n<\/ul>\n

      The handbook now provides clearer guidance on which roles are required to:<\/p>\n

        \n
      • \n

        submit initial applications (IN)<\/p>\n<\/li>\n

      • \n

        submit modifications (SM\/AM\/NSM)<\/p>\n<\/li>\n

      • \n

        notify events (e.g., urgent safety measures, SUSARs)<\/p>\n<\/li>\n

      • \n

        upload the Annual Safety Report (ASR)<\/strong> or the Clinical Study Report (CSR)<\/p>\n<\/li>\n<\/ul>\n

        In addition, the criteria for assigning and requesting roles have been updated, improving the internal management of authorizations.<\/p>\n

        Notifications and events: more detailed operational guidance<\/h2>\n

        The new version of the handbook expands the section dedicated to managing events during the conduct of a clinical trial. Key updates include:<\/p>\n

          \n
        • Detailed instructions on how and when to report unexpected events, urgent safety measures, serious breaches, and inspections.<\/li>\n
        • New guidance on responding to Requests for Information (RFIs), both during the assessment phase and throughout monitoring.<\/li>\n
        • A clear procedure for submitting and amending Substantial and Non-Substantial Modifications, including changes to the sponsor.<\/li>\n<\/ul>\n

          Clinical Study Report: what\u2019s new<\/h2>\n

          One of the most significant updates is the introduction of a dedicated section on the Clinical Study Report (CSR), which now provides guidance on:<\/p>\n

            \n
          • content structure<\/li>\n
          • required user roles for submission<\/li>\n
          • timelines<\/li>\n
          • procedures for updates and withdrawal<\/li>\n<\/ul>\n

            As outlined in Article 37 of Regulation 536\/2014, the CSR now becomes an essential component of the final documentation, alongside the technical summary and the lay summary for the public.<\/p>\n

            Transparency and data protection<\/strong><\/p>\n

            The chapter on data publication<\/strong> has been updated to reflect the latest EMA provisions regarding the protection of personal data and commercially confidential information (CCI)<\/strong>.<\/p>\n

            The handbook:<\/p>\n

              \n
            • clarifies which sections of applications and documents will be automatically made public<\/li>\n
            • details the criteria for redacting or deferring sensitive information<\/li>\n
            • provides practical examples on entering the trade name in the XEVMPD<\/li>\n<\/ul>\n

              Particular emphasis is placed on upholding the principle of transparency towards patients and researchers through the CTIS public website.<\/p>\n

              Registrations and timelines: a warning for sponsor<\/h2>\n

              Chapter 1 reinforces the importance of completing the preparatory steps before submission:<\/p>\n

                \n
              • \n

                registering the organization in the OMS \u2013 Organisation Management Service<\/strong> (up to 10 days)<\/p>\n<\/li>\n

              • \n

                registration in EudraVigilance<\/strong> (duration may vary)<\/p>\n<\/li>\n

              • \n

                registration of investigational medicinal products in the XEVMPD<\/strong> \u2013 Extended EudraVigilance Medicinal Product Dictionary<\/p>\n<\/li>\n

              • \n

                enabling MFA<\/strong> \u2013 Multi-Factor Authentication for EMA accounts<\/p>\n<\/li>\n<\/ul>\n

                Sponsors are also advised not to use<\/strong> the \u201cnew local organization\u201d function in CTIS, and to always register through OMS to avoid future issues (e.g., with the management of ASRs).<\/p>\n

                Support and training: new EMA resources<\/h2>\n

                The final section of the handbook brings together a wide range of training and support tools:<\/p>\n

                  \n
                • new video tutorials<\/strong> explaining the differences between the two user approaches<\/li>\n
                • links to the most recent documents<\/strong> (CTR Q&A, Quick Guide, CTCG guidelines)<\/li>\n
                • access to the CTIS training environment for internal use<\/li>\n
                • contact channels for technical support (EMA Service Desk)<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

                  Version 6.0 of the CTIS Sponsor Handbook brings substantial updates to the operational guidance for managing clinical trials in Europe. New rules on roles, access, transparency, results submission, and the CSR: a key step forward for all sponsor.<\/p>\n","protected":false},"author":33,"featured_media":24199,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[832,821,1101],"tags":[],"class_list":{"0":"post-24489","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-clinical-research","8":"category-guidelines","9":"category-highlights-en"},"yoast_head":"\nCTIS\u20116.0. Changes to the rules for clinical trial sponsor - MakingPharmaIndustry<\/title>\n<meta name=\"description\" content=\"CTIS Sponsor Handbook 6.0: tutte le novit\u00e0 EMA su ruoli, CSR, trasparenza e gestione dei trial clinici nell\u2019UE. 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