CTU Day 2025 - Wrap up
ECRIN hosted its 5th CTU Day on Friday 12 December 2025. This online event brought together more than 200 members from ECRIN's national partner networks.
This year, we covered an update of ECRIN's services and tools. We started by outlining ECRIN's Clinical Operations structure, including services and staff across Europe. We shared ECRIN's role within ACT-EU, where we represent the academic perspective of (multi-country) clinical trials. We then focused on two national partners, France (F-CRIN) and Poland (PCTN) who shared the structure of their national organisation and the links that have been developed with ECRIN.
CTU Day is about keeping our community in the know of what is happening more largely in clinical research and for this we included an update on the ECRIN data tools, Sergio Contrino, Head of Data Projects at ECRIN, spoke about the existing difficulties of data sharing within the clinical trial research community and how important early planning is. He then shared an example of IPD (individual participant data) data sharing in a study protocol and closed by detailing the crDSR and crMDR that ECRIN has developed which support the community to make data more FAIR.
This year the primary focus of the CTU Day was dedicated to give CTUs a platform to discuss the implementation of ICH E6 R3. Niall Hore, our Irish EuCo, welcomed representatives from CTUs in Switzerland, Ireland and Spain, who are all in the process of implementing the revision, share their experiences with the audience.
Christina Huf, from SCTO in Switzerland and ECRIN EuCo, begun the discussion by sharing examples of events tools and projects initiated addressing the changes. She gave an example of the Easy GCS tool that they developed as an interactive guide to plan and conduct a study. Michael Coslovsky from DKF Basel then spoke to provide a use case example on the computerised systems validation policy for R. He explained that most CTUs in Switzerland use R as a software for statistical analysis and went over the difficulties in validating such versatile software, the stakeholders involved and what is coordinated at a national level versus a CTU level.
We then heard from John Casey on Implementing GCP R3 in Children’s Health Ireland. John provided the positives and challenges associated with implementing these changes and notably how they developed various trainings for staff and investigators. John expressed how R3 implementation is a team effort and that people need to understand it and feel part of the process and see the progress.
Next up, Paloma Moraga Alapont showed the path taken to implement ICH E6 R3 from the University Hospital La Paz in Madrid. She explained that the change to R3 encouraged a risk-based and proportional approach with flexible and trial-adapted processes and smart and targeted monitoring. Paloma provided a timeline that clearly demonstrated the implementation path of ICH E6 (R3) in their Clinical Trials Unit with the goal of improving the quality and reliability of data obtained.
We finished with a discussion with the panelists were invited back to take questions from the audience and discuss their experiences and perspectives. One of the largest difficulties encountered by all was the time between publication and implementation.
Through the discussion it was explained by all that the shift from R2 to R3 was not that big, that R3 simply brought about a bigger clarity on the requirements of some elements.
The online event was well received by all who attended. Thank you to all presenters and to our audience for participating. We look forward to seeing what topic is prominent to discuss next year.
The webpage with the agenda can be found below:
