Data Centre Certification
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 the list of centres that have received ECRIN Data Certification, click here.
Certification of data centres – 2018 call
ECRIN-ERIC is continuing its Data Centre Certification programme throughout 2018 following successful round of audits in 2014, 2015, 2016 and 2017.
Centres will be selected for audit within National Clinical Research Networks (scientific partner of ECRIN) and after assessment of their application by the ECRIN Independent Certification Board (ICB). The main criterion will be the ability of units to meet the quality standards requested by ECRIN, as indicated by the application form and supporting documents.
Applications are invited this year from clinical trials units within the national networks of ECRIN-ERIC members (France, Germany, Spain, Portugal, Italy, Hungary, Norway, Czech Republic) who wish to become an ECRIN certified data centre. The process in 2018 will be funded by ECRIN-ERIC, so there are no fees for centres selected for audit.
Applications are also invited this year from clinical trials units within the national networks of ECRIN-ERIC observers (Switzerland), but such audits will carry a not-for-profit cost (direct expense cost, expected at around 6000€). Please contact the ECRIN Paris offices for further details.
Certification decisions will be 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 is September 28th, 2018.
The ECRIN certification standards
The first version of the ECRIN certification standards was created in 2010 and published in the journal Trials in 2011 (see reference 1 in the Publications section below). Updates of the standards (Version 2.2) were published in 2013 in Trials (see 2), and in 2015 (Version 3.0) in the EU database Zenodo (see 3).
The standards are split into three main areas, and one optional area as shown below. 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.
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 (http://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 (http://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 (http://zenodo.org/record/32690#.VzX3S1hJnDc)
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 (http://www.sciencedirect.com/science/article/pii/S2451865416300825)