The European Medicines Agency (EMA) published a new training module on April 7, 2026, aimed at assisting sponsors and researchers in using the Clinical Trial Information System (CTIS) for submitting clinical trial applications. The module covers the notification process for substantial modifications to ongoing trials, impacting pharmaceutical companies, contract research organizations, and academic institutions conducting clinical trials in the EU.
The training module, developed by EMA's Clinical Trials and Human Medicines Division, is part of the agency's ongoing efforts to support the implementation of the Clinical Trials Regulation (EU) No 536/2014, which became applicable on January 31, 2022. The regulation introduced a centralized EU portal and database (CTIS) for clinical trial applications, replacing national submission systems.
Document Type and Status The module is a guidance document and is not legally binding. It provides step-by-step instructions and best practices for using CTIS to notify substantial modifications, which are changes that may significantly impact the safety or rights of trial subjects or the reliability of data. The module includes screenshots and practical examples to facilitate user understanding.
Policy Orientations and Trade-offs The module aims to streamline the notification process, reducing administrative burden for sponsors and ensuring timely updates to regulatory authorities. However, it also imposes a structured approach that may require additional training for users unfamiliar with the system. The trade-off lies between efficiency gains from standardized procedures and the initial learning curve for stakeholders.
Impact on Stakeholders - Pharmaceutical companies and CROs: Positive impact through clearer guidance, potentially reducing errors and delays in submissions. However, they may need to invest time in training staff on the new module. - National competent authorities: Benefit from more consistent and complete notifications, facilitating oversight. No direct negative impact. - Academic researchers: May face challenges if they lack resources for training, but the module could improve their compliance with regulatory requirements. - Patients: Indirect positive impact through potentially faster and safer clinical trial modifications.
Expected Institutional Follow-up The EMA is expected to continue updating training materials as CTIS evolves. The module is available on the EMA website and will be promoted through stakeholder workshops and webinars. No further regulatory action is required.
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