Objective: The ECRIN certification programme is designed to audit data centres to confirm their ability to provide compliant effective and efficient data management services for clinical trials as well as to provide a clear interpretation of regulatory and good practice requirements.
Method: Initiated by ECRIN in 2011, the programme is based on a set of 106 standards dealing with IT, data management, and some more generic aspects of trial management. Based on the results of an on-site audit the certification decision is made by the ECRIN Independent Certification Board.
Results: The first version of the ECRIN certification standards was created in 2010 and published in 2011 ; updated versions were published in 2013 and 2015. The current version (2018) is available on Zenodo . The standards are split into three main areas: General standards, IT standards, Data management standards; they act as a guide to establishing and managing high-quality data management services. 
Since the launch of the programme, 13 European clinical data centres have been certified and a first pilot has been performed outside Europe with 1 centre successfully certified in Japan in 2019; in addition a data centre for malaria trials in Mozambique is currently under certification.
Conclusion: High-quality data management is a critical point in the performance of clinical studies; however, academic Clinical Trial Units (CTU) and data centres face challenges related to considerable heterogeneity in the use of different software products for data management and deficits in the quality of data management. The ECRIN Data Centre Certification programme identifies non-commercial clinical trial units (CTUs) demonstrating that they can provide safe, secure, compliant and efficient management of clinical research data. The standards detail pragmatic statements of good practice tailored at academic centre; the emphasis is on clinical trials in the non-commercial sector, but the same principles apply to data management in non-interventional studies, and indeed to clinical research in any context. The programme has been successfully evaluated .
The next step will be the promotion of further harmonisation and standardisation of study protocols and practice by the globalisation of the certification programme; this will be achieved within the Clinical Research Initiative for Global Health (CRIGH)  by creating an active community of candidates and currently certified units, and supporting national implementations of high-quality clinical data management.

Enhancing High-Quality Data Management Services in Non-Commercial Clinical Trials