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 the 2016 Call (also described below).
The certification process entails a two- to three-day, on-site audit of a CTU led by an independent Certification Board. Audits are based on standard requirements (see below) in three areas: IT, data management and general. These standards were developed by ECRIN in 2011 and updated in 2012 and 2015.
Compliance with the standards confirms a centre's capacity to provide appropriate and effective data management services for multinational, randomised controlled trials (RCTs) and ECRIN-supported trials.
Based on the outcome of the audit, a centre may be designated as an ECRIN Data Centre. Certified ECRIN Data Centres are invited to sign a collaborative agreement with ECRIN to become affiliate partners. For the list of centres that have received ECRIN Data Certification, click here.
Currently, 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. To download a full copy of the standards (pdf), click here.
ECRIN continued its Data Centre Certification programme in 2016 following successful rounds of audits in 2014 and 2015.
Applications were invited in 2016 from CTUs within the national networks of ECRIN Member Countries (France, Germany, Hungary, Italy, Norway, Portugal, Spain) who wished to become an ECRIN certified data centre. The intention in 2016 was to select and audit one centre from each of these countries.
As described above, certification decisions were based on the results of a two- to three-day, on-site audit of a centre’s systems and procedures, which is led by an independent Certification Board. The process in 2016 was funded by ECRIN, so there were no fees for centres selected for an audit.
The application form for certification is available to download here. Note that the closing date for applications (August 31st, 2016) has now passed.
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