15 March 2021

Quality label for the DKF Clinical Data Centre

With certification by the European research network ECRIN, the data-related services and IT infrastructure at the DKF have reached a new standard.

Data handling in clinical research is particularly delicate, as patient data is sensitive information and often involves handling complex and large data sets. Systems, processes and IT infrastructures in such an environment must be secure and the handling of personal data must conform to applicable laws and standards.

Certification by the European Clinical Research Infrastructure Network (ECRIN) now confirms that the Clinical Data Centre at the Departement Klinische Forschung (DKF) meets these high quality standards.

First certified centre in Switzerland

The DKF is the first institution in Switzerland to receive this quality label. There are 17 certified centers throughout Europe. All preparations, adjustments and audits to obtain the certification took a good two years. The certification is a consequence of the DKF's investments in its focus areas Data Analysis, Data Management and Data Science, which have been consistently carried out for years.

Enhancing academic research

The ECRIN certification program is targeted at data centers in the academic setting and consists of over 100 standards, summarized in 16 thematic chapters. Its requirements together with detailed explanations are publicly available. They are now considered a prerequisite for conducting complex investigator-initiated studies or pivotal trials.

In terms of content, the ECRIN standards are derived from the well-known ICH GCP Guideline, the globally recognized guideline that sets the standard for ethical and scientific principles in clinical research in general. However, the ECRIN standards concretize what ICH GCP often formulates only vaguely, thus offering data managers, data scientists and IT specialists detailed and pragmatic guidance for daily practice.

For the benefit of patients and researchers

In the end, researchers benefit from smooth and secure processes in their research projects, as the highest data quality and IT security are guaranteed from the planning of the study database to the final data evaluation. Patients can rest assured that their personal data will be managed securely and used to the greatest benefit of the research project.