Certification of non-commercial European data centres

Data Centre Certification

The ECRIN Data Centre Certification programme identifies non-commercial clinical trials units (CTUs) 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 [1]. 

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

How to apply for certification – 2019 call

ECRIN is continuing its Data Centre Certification programme in 2019. Centres will be selected for audit within the national networks of ECRIN’s scientific partners 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:

  • CTUs within the national networks of ECRIN members (Czech Republic, France, Germany, Hungary, Ireland, Italy, Norway, Portugal and Spain). For these CTUs, there are no application/audit fees in 2019. 
  • CTUs within the national networks of ECRIN observers (Switzerland and Slovakia), 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 an on-site audit of a centre’s systems and procedures, as considered by the ICB

The 2019 application form for certification is available here. The deadline for applications is September 27th, 2019 (now closed).

Where certification is successful, it will be granted for 4 years. Certified units within the national networks of ECRIN member and observer countries who wish to renew their certification should directly contact christian.ohmann@med.uni-duesseldorf.de, cc: jacques.demotes@ecrin.org, Christine.toneatti@ecrin.org.

For further information about certification, please refer to the 2019 Call for Applications - Guideline document or contact your European Correspondent.

The ECRIN certification standards 

The current criteria for certification with explanation and elaboration (version 4.0 from April 2018) are available for download here and on Zenodo here [2].

The first version of the ECRIN certification standards was created in 2010 and published in the journal Trials in 2011 [3]. Updates of the standards (Version 2.2) were published in 2013 in Trials [4], and in 2015 (Version 3.0) in the EU database Zenodo [5].

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.

Standards v4 image.png

Publications & Reports

1. 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)

2. 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)

3. 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)

4. 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)

5. 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)

REPORT: "Survey on impact of ECRIN data centre certification on inspections by regulatory authorities" (C. Ohmann, C. Toneatti, August 2019)