Innovative methods for pseudonymization in multi-center research networks

Large biomedical research networks facilitate the collection and integration of data, biospecimens, and expertise to develop innovative approaches for therapy, diagnostics, and prevention. The ORCHESTRA project is an example of such a network, bringing together data from more than 2.3 million participants across multiple continents to improve the prevention and treatment of COVID-19. One of the main challenges in establishing the multi-center network was the heterogeneous information technology (IT) infrastructure at the participating centers, which included both centralized and decentralized components operating under different regulatory and organizational frameworks. A best practice for effective and legally compliant research data management is pseudonymization, which means that identifying data about patients and study participants is managed separately from biomedical data and biospecimens. However, no widely adopted pseudonymization infrastructure currently exists that can be easily integrated into research networks, which posed a particular challenge when rapidly establishing ORCHESTRA to address the COVID-19 crisis in Europe. To address this need, the ORCHESTRA Pseudonymization Tool (OPT) was developed. The OPT is a lightweight, scalable, and user-friendly solution designed for rapid decentralized deployment in multi-center research networks. It supports both prospective and retrospective study designs and enables the flexible management of pseudonymization processes. The tool has been deployed in ORCHESTRA at 19 sites in 13 countries, protecting more than 30,000 study subjects and 15,000 associated biosamples. It was specifically designed for ease of use in resource-limited environments, runs on various operating systems, and does not require centralized IT infrastructure. Through continuous user feedback, OPT has been regularly improved, achieving high user satisfaction. It was also later adopted in other research projects. The results demonstrate that the OPT is a viable solution for pseudonymization in large-scale, multi-center research networks and made a significant contribution to the secure and efficient use of sensitive biomedical data in ORCHESTRA.