The ECRIN Data Centre Certification programme identifies non-commercial clinical trials units in Europe that have demonstrated they can provide safe, secure, compliant and efficient management of clinical research data. It does so by testing the units for compliance with published ECRIN data standards, using an on-site audit of the unit’s data management activities and of the IT infrastructure used to support those activities (see reference 4 in the Publications section below).
For further information about certification, please refer below or contact your European Correspondent.
For the list of centres that have received ECRIN Data Certification, click here.
Certification of data centres – calls
ECRIN will continue its Data Centre Certification programme in 2019 following successful rounds of audits in 2014, 2015, 2016, 2017 and 2018.
In 2018, centres were selected for audit within National Clinical Research Networks (ECRIN's scientific partners) and after assessment of their application by the ECRIN Independent Certification Board (ICB). The main criterion for selection is the ability of units to meet the quality standards requested by ECRIN, as indicated by the application form and supporting documents.
Applications were invited in 2018 from clinical trials units (CTUs) within the national networks of ECRIN Member Countries (France, Germany, Spain, Portugal, Italy, Hungary, Norway, Czech Republic) wishing to become an ECRIN certified data centre. The process in 2018 was funded by ECRIN, so there were no fees for centres selected for an audit.
Applications were also invited in 2018 from CTUs within the national networks of ECRIN Observer Countries (Switzerland), but such audits carried a not-for-profit cost (direct expense cost, expected at around 6000€). Please contact the ECRIN Paris office for further details.
Certification decisions are based on the results of a 2-3 day, on-site audit of a centre’s systems and procedures, as considered by an Independent Certification Board.
The application form for certification is available here. The closing date for applications was September 28th, 2018. (More information on the 2019 call will be coming soon.)
The ECRIN certification standards
In light of significant changes in recent years (e.g. increasing use of cloud-based infrastructure and ‘software as a service’ for clinical trial data management, new regulatory requirements for data integrity), the ECRIN standards underwent a comprehensive review in 2017. The new revised version 4.0 of the standards was published in 2018 (see reference 5 below). The current criteria for certification with explanation and elaboration (version 4.0 from April 2018) are available for download here.
The standards are split into three main areas, and one optional area as shown above. They provide a clear interpretation of regulatory and good practice requirements, and act as a guide to establishing and managing high-quality data management services.
Previous versions of the standards
The first version of the ECRIN certification standards was created in 2010 and published in the journal Trials in 2011 (see reference 1 below). Version 2.2 was published in 2013 in Trials (reference 2) and Version 3.0 was published in 2015 in the EU database Zenodo (reference 3).
1. Ohmann et al.: Standard requirements for GCP-compliant data management in multinational clinical trials. Trials, 2011; 12:85. DOI: 10.1186/1745-6215-12-85 (https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-12-85)
2. Ohmann et al.: Revising the ECRIN standard requirements for information technology and data management in clinical trials. Trials, 2013; 14:97. DOI: 10.1186/1745-6215-14-97 (https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-97)
3. Canham et al.: Requirements for Certification of ECRIN Data Centres, with Explanation and Elaboration of Standards, Version 3.0. Zenodo, 2015. DOI: 10.5281/zenodo.32690 (https://zenodo.org/record/32690#.XL8WqTAzbct)
4. 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)
5. 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)