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ECRIN — European Clinical Research Infrastructure Network

Overview

ECRIN (European Clinical Research Infrastructure Network) is a European research infrastructure that supports the conduct of multinational, non-commercial clinical trials and other clinical research studies across Europe. Established in 2004 and headquartered in Paris, ECRIN became an ERIC in November 2013. It provides regulatory expertise, data management support, and a network of national partner organisations that facilitate the practical aspects of running clinical studies across multiple European countries, covering regulatory submissions, ethics approvals, data collection, and monitoring.

What ECRIN Does

Multinational Trial Support

ECRIN’s core service is enabling non-commercial (academic) clinical trials to recruit patients across multiple European countries simultaneously. Regulatory support covers navigating different national competent authorities (ANSM in France, MHRA in UK, BfArM in Germany, etc.) for multinational CTA submissions. Ethics coordination supports parallel ethics (CPP) submissions across countries. The national partner network of ECRIN NCPs is embedded in national clinical research networks and handles local logistics.

Data Management and Standards

ECRIN promotes harmonised clinical trial data standards. It endorses CDISC SDTM/ADaM/CDASH for trial data structure, uses OMOP CDM for harmonising observational data across studies, and contributes to HL7 FHIR-based clinical trial interoperability. It supports registration on ClinicalTrials.gov and EudraCT/CTIS.

CTIS and EudraCT

Under the EU Clinical Trials Regulation (EU 536/2014), ECRIN is a key actor in the transition to CTIS (Clinical Trials Information System), the single EU-wide portal for clinical trial applications that replaced national submissions to each member state separately. EudraCT was fully replaced by CTIS from January 2025. ECRIN provides training and support for sponsors navigating the CTIS submission process.

REDCap Network

ECRIN operates the ECRIN REDCap Network, a secure, GDPR-compliant instance of REDCap available to ECRIN-supported studies.

ESFRI Cluster

ECRIN is part of the ESFRI Health Research Infrastructure cluster with ELIXIR, BBMRI-ERIC, EATRIS, and Euro-BioImaging.

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