Certification of non-commercial European data centres

Data Centre Certification

ECRIN’s Data Centre Certification programme is ISO 9001:2015 certified and was developed to audit European, non-commercial data centres using ECRIN IT/DM standards, and to confirm their ability to provide compliant, effective, and efficient data management services for controlled clinical trials. The goal is to enhance high-quality data management services in non-commercial clinical trials and to contribute to the harmonisation of European practice in data management. Since it was set up in 2014, 17 European data centres have been certified.

ECRIN’s certification programme assesses 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].

How to apply for certification 

The Data Centre Certification applies to centres pre-selected by 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. A data centre's ability to meet the standards must be demonstrated using two recent studies where it is responsible for data management. Where certification is successful, it will be granted for 4 years.

  • Clinical trial units (CTUs) within the national networks of ECRIN members (Czech Republic, France, Germany, Hungary, Ireland, Italy, Norway, Portugal and Spain) are required to pay no application/audit fees.
  • CTUs within the national networks of ECRIN observers (Poland, Switzerland and Slovakia) will be required to finance a not-for-profit cost (direct expense cost, expected at around 6000€). Please contact the ECRIN Paris offices for further details.

For further information about certification or renewal, please directly contact christian.ohmann@med.uni-duesseldorf.de,

cc: jacques.demotes@ecrin.org, christine.toneatti@ecrin.org.

2020 call cancelled

ECRIN cancelled the Data Centre Certification call for 2020 due to the unpredictable evolution of COVID-19 pandemic and its impact on the feasibility of on-site initial performance audits as well as specific restrictions or recommendations for travelling by European governments.

The current audit plan (resulting from the 2019 call and the follow up of previous audits) is continued with prioritisation of audit activities that can be progressed remotely (certification renewal, re-audits where feasible and CAPA review audits).

All on-site audit activities have been postponed to 2021. A case by case assessment and reprogramming will be applied taking into account specific governmental recommendations and restrictions as they are updated.

Certification decisions for activities that are pursued will be based on the results of a remote audit of a centre’s systems and procedures, as considered by the ICB.

Expansion of the programme beyond Europe

In 2018, it was decided to expand the programme as a pilot beyond Europe. Non-EU interested countries can apply for one pilot audit and request the training of local auditors. Three auditors were trained and one data management centre was certified last year in Japan. The goal is to have parallel programmes in academic data management centres within various regions of the world.

Following the pilot, initiated in Japan to globalise the Data Centre Certification programme, ECRIN conducted an initial audit of the Medical Research Collaboration Center (MRCC) at Seoul National University Hospital in Seoul, South Korea, from January 13th to 17th, 2020. The Data Centre Certification was awarded to MRCC at the end of 2020. 

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) 

Certification Programme Training and Presentations:

ECRIN – CDISC joint training to partner CTUs and auditors, April 11th, 2019

EU Quality Conference, Dublin, November 6-8th 2019, Title:  Enhancing High-Quality Data Management Services in European Non-Commercial Clinical Trials

23rd DIA Japan Annual Workshop for Clinical Data Management, February 5-6, 2020, Tokyo, Title: Activity report of CRIGH Project 6: Clinical Data Management

DIA Europe Annual Workshop Abstract Virtual, July 2020, Title: Enhancing High-Quality Data Management Services in Non-Commercial Clinical Trials.