Data Centre Certification

The ECRIN Data Centre Certification programme identifies non-commercial clinical trial units (CTUs) in Europe demonstrating that they can provide safe, secure, compliant and efficient management of clinical research data. The programme tests units for compliance with published ECRIN data standards through on-site audits of units' data management activities and the information technology (IT) infrastructure used to support these activities. ECRIN strongly recommends the use of certified data centres for the multinational trials it supports.

To find out how to apply to be audited as part of the ECRIN Data Centre Certification programme, see below. 

For the list of centres that have received ECRIN Data Certification, click here.

Certification of Data Centres – 2017 Call

ECRIN is continuing its Data Centre Certification programme throughout 2017 following successful rounds of audits in 2014, 2015 and 2016.

Applications are invited this year from CTUs within the national networks of ECRIN member countries (France, Germany, Spain, Portugal, Italy, Hungary, Norway) who wish to become an ECRIN certified data centre. The process in 2017 will be funded by ECRIN, so there are no fees for centres selected for audit.

Applications are also invited this year from CTUs within the national networks of ECRIN observer countries (Switzerland, the Czech Republic), but such audits will carry a not-for-profit cost (direct expense cost, expected at around €6000). Please contact the ECRIN Paris office 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.

Application Form

The application form for certification is available to download here. The closing date for applications is August 31st 2017.

For further information about certification, please refer to the document “ECRIN certification call 2017” or contact your European Correspondent.

The Criteria

The current criteria for certification with explanation and elaboration (version 3.1 from January 2016) are available for download here.

The standards are split into three main areas, as shown in the figure 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.

data_certification_standards.png

History of the Standards

The first version of the ECRIN certification standards was created in 2010 and published in the journal Trials in 2011 (1). Updates of the standards (Version 2.2) were published in 2013 in the Trials (see 2), and in 2015 (Version 3.0) in the EU database Zenodo (see 3). The current version of the standards (Version 3.1) with explanations and explorations is available here.

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)