ECRIN 2030 · European Clinical Research Infrastructure Network 2030

ECRIN 2030 will address three of the major challenges for clinical research in Europe over the next decade: 1. ECRIN preparedness for the European Health Data Space (EHDS) Regulation; 2. services to decentralised trials; 3. membership expansion and international cooperation. The EHDS Regulation provides Europe with a harmonised framework for the secondary use of real-world data for clinical trials and for clinical trial data sharing. Pillar 1 will prepare ECRIN for EHDS implementation in 2029, capturing the national requirements to obtain approvals for data sharing or secondary use, and establishing ECRIN as an Authorised Participant in the EHDS ecosystem, able to deliver Access Approvals (WP1). Based on this, ECRIN will develop a technical and regulatory capacity to offer services for clinical trial data sharing (WP2) and for secondary use of electronic health records in clinical trials (WP3). Secondary use and remote data collection will facilitate fully or partly decentralised trials. Adequate infrastructure and support services will be developed in Pillar 2 to assist investigators and sponsors in the planning and conduct of such trials. Decentralised elements introduce specific regulatory and operational challenges - such as patient information, eConsent, investigational product dispensing, monitoring, and safety reporting - which are addressed inconsistently across European countries. Moreover, an AI-based solution using Large Language Models will be proposed to translate wearable data into clinical trial data standards (WP4). Pillar 3 will develop a consistent strategy for ECRIN membership expansion based on a collection of the reasons for hesitancy in the non-member regions (WP5). It will also promote international cooperation, both with countries equipped with mature CTU networks (Canada, New-Zealand, Japan), and with less mature countries through capacity building and mentoring programmes aligned with the WHO strategy and the WHA 75.8 Resolution (WP6).