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, 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, performing an 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 programme is open to centres that satisfy the following conditions:

  1. The applicant CTU is located within the national network of an ECRIN member country (Czech Republic, France, Germany, Hungary, Ireland, Italy, Norway, Portugal or Spain) and will not be required to pay application/audit fees. 

OR

  1. The applicant CTU is located within the national network of an ECRIN observer country (Poland, Switzerland or Slovakia) and must be prepared for the not-for-profit cost that will apply (a direct expense cost, approximately 6000€). Please contact the ECRIN Paris head offices for further details.

AND

  1. The applicant has been pre-selected by the ECRIN national scientific partner as confirmed by the head of the national network.
  2. Each applicant centre should contact Christine.toneatti@ecrin.org to access the link to an automated application questionnaire. The final deadline for applications is 27 September 2021.
  3. Upon receipt, and review of the completed questionnaire, the ECRIN Independent Certification Board Secretary (ICB) confirms data centre readiness for audit: the main criterion will be the ability of the data centre to meet the IT/DM standards requested by ECRIN, and its ability to demonstrate their application in the context of at least two recent studies (where the CTU was responsible for the data management). This may guide the choice for the most suitable audit period.

 

The Certification Process:

ECRIN adapted the audit process to include remote auditing to ensure the audit programme’s continuity during the COVID-19 pandemic. Certification decisions will be based on the results of an audit (that could be conducted on-site or remotely based on the auditors’ decision) of a centre’s systems and procedures, as considered by the ICB.

The audit team will be comprised of up to three senior trial unit staff members qualified in IT/DM clinical trial quality, and auditing according to the ECRIN IT/DM standards. Audits will last up to three days and be conducted in English, though usually at least one of the team members will be fluent in the native language of the centre being audited so that local documents can be examined.

Please note that if a centre uses an external supplier for some of its IT or data management systems, for example, if it uses IT services provided by its parent university, the centre will still be expected to have all the relevant evidence available during the audit. It will have to arrange, where necessary, for the relevant staff to be available.

The results of the audit will be relayed informally to the centre before being presented to the ICB, which will make the final certification decision.

 

The decision on centre certification by the ICB will be one of the following:

 a) If it feels all standards have been met, the ICB can award ECRIN certification;

b) If almost all standards have been met, the ICB can recommend that the centre provide written CAPA evidence, usually within six months, indicating how it has complied with the remaining standards, after which the certification decision will be reconsidered;

c) If most standards have been met, the ICB can recommend that the centre have a re-audit after a mutually agreed upon time to examine compliance with the remaining standards, after which the certification decision will be reconsidered;

d) If the ICB feels that the level of non-compliance is such that options b) or c) are unrealistic, it can withhold certification. In this case, the centre will need to re-apply for certification to be considered in the future.

The details of the audit will be confidential and auditors will sign confidentiality agreements with the centres. ECRIN reserves the right, however, to publicise the names of the centres selected for audit and the overall result (name and location of certified centres, centres with audit pending, centres with certification in progress).

 

Where certification is successful, it will be granted for 4 years.

 

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 two data management centre were certified in Japan. The goal is to have parallel programmes in academic data management centres within various regions of the world.

In the continuation of 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.

 

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.