European Clinical Research Infrastructure Network (ECRIN)
Christine Toneatti is the head of the quality and information systems unit at ECRIN’s central Paris office, overseeing the quality system, managing risks and optimising architecture, hosting, maintenance, access and security of ECRIN information systems.
She has over 30 years’ of experience in biomedical research; initially as researcher and project manager in the field of infectious diseases, including involvement in drug and vaccine development programmes ranging from research and non-clinical development to clinical phases I to IV, and epidemiology. Since 2000, she has provided leadership in the development and implementation of quality management systems in Good-X-Practice regulatory, research and ISO environments for various industrial companies (Wyeth, IPSEN, GSK) and academic organisations (ANRS, INSERM, Pasteur Institute). As an international auditor, she coordinated and perform non-clinical, clinical, and information systems audits and hosted inspections by governmental agencies (EU, Japan). She has an MSc (Parasitology) and MSc, (Quality and Research Management, awarded) from Cranfield University, UK; she is ISO 27001:2013 certified and has got degrees in Statistics and Ethics.
Enhancing High-Quality Data Management Services in European NonCommercial Clinical Trials
There is a wide consensus around the need for high-quality data management in biomedical research to avoid poor repeatability of clinical research findings and doubt about the credibility of research results. However, clinical trials are plagued by manual and outdated data collection methods. In the context of academia, EU regulation 536/2014 introduced new features which aim at facilitating international academic clinical research. However, European academic Clinical Trial Units (CTU) and data centres are facing challenges related to considerable heterogeneity in the use of different software products for data management, deficits in the quality of data management, including in computer system validation and constraints with limited human and financial resources.
In this context, ECRIN established in 2015 a European data centre certification programme; Aim of the programme is to provide a clear interpretation of regulatory and good practice requirements for academic CTUs and to confirm the ability of CTUs to provide compliant, effective and efficient data management services for clinical trials.
Major components of the programme are the reference standards requirements for Information Technology and Data Management in clinical trials (ECRIN DM/IT standards) , an independent Certification Board, qualified international auditors, a scientific secretary and audit systems and maintenance.
Following a yearly call, so far 36 independent audits have been performed, 11 European data centres have been certified in 5 countries as well as 1 Japanese data centre. In addition, continuous auditors training and a joint ECRIN/CDISC training initiative have been performed. Evaluation of the programme revealed that the ECRIN DM/IT standards are detailed pragmatic statements of good practice associated to evidence-based records, tailored at academic CTUs having national impact to increase the quality of DM services (E.g. Switzerland, Germany, France, Japan, Korea, Singapore) ; Programme participation rewards through the sharing of latest technical developments, training of CTUs on DM, and auditors receive advanced training with IT/DM, creating potential for lead expert role in a country. Globalisation of the programme has recently been started in Asia (E.g.: Japan, South-Korea).
1. Canham et al.: Requirements for Certification of ECRIN Data Centres, with Explanation and Elaboration of Standards, Version 4.0. 27 April 2018. DOI: 10.5281/zenodo.1240941 (https://zenodo.org/record/1240941#.XL8VATAzbct)
2. Ohmann et al.: Raising standards in clinical research–The impact of the ECRIN data centre certification programme, 2011–2016. Contemporary Clinical Trials Communications, 2017; 153:159. DOI: 10.1016/j.conctc.2017.02.005 (https://www.sciencedirect.com/science/article/pii/S2451865416300825)