European Data Protection Board Guidelines 01/2025 clarify how pseudonymisation should be understood and implemented under the General Data Protection Regulation, explaining its legal definition, risk‑reduction potential, and limits. They guide controllers and processors on when and how to use pseudonymisation to support data minimisation, data protection by design and by default, security of processing, lawful further use and international transfers, while stressing that pseudonymised data remain personal data and must still comply with all General Data Protection Regulation obligations.

Open‑access article in Trials that evaluates how suitable existing data repositories are for hosting individual participant data from clinical studies, from the perspective of clinical researchers. The authors assessed 25 repositories (from an initial 55 identified) using a predefined set of 34 items covering guidance for data upload and de‑identification, data quality controls, contracts, access options, identifiers, metadata and long‑term preservation. None of the repositories fully met all criteria, but three generic repositories (Dryad, DRUM and EASY) fulfilled all indicators fully or partially; most did not charge fees for upload, storage or access. The study highlights wide heterogeneity and information gaps, and offers an evidence‑based starting point for investigators choosing a repository for clinical study datasets.

Open‑access consensus article in BMJ Open that sets out principles and practical recommendations for sharing and reuse of individual participant data from clinical trials. Developed by a multistakeholder European task force led by the European Clinical Research Infrastructure Network as part of Horizon 2020 CORBEL project, it focuses mainly on non‑commercial trials and examines key issues such as consent for data sharing, protection of trial participants, data standards, access models, repositories and metadata. The paper presents 10 overarching principles and 50 recommendations intended to guide ethics‑compliant, high‑quality individual participant data sharing in clinical research.

Developed by the European Clinical Research Infrastructure Network (ECRIN) within the ERA4Health Partnership, the document shares pratical guidance on how to prepare data sharing plans for clinical studies, and how to design General Data Protection Regulation (GDPR)‑compliant strategies for sharing Individual Patient Data (IPD), including informed consent for secondary use and long‑term storage in repositories that follow FAIR (Findable, Accessible, Interoperable and Reusable) principles. It aligns data sharing planning with expectations from European and international funders and is aimed at investigators, funders, research staff and other stakeholders involved in investigator‑initiated clinical trials.

Guideline from the European Medicines Agency on the use of computerised systems and electronic data in clinical trials (EMA/INS/GCP/112288/2023). It sets principles and requirements for instruments, software and “as a service” solutions used to create, capture, process, store and archive electronic clinical data across the full data life cycle. Topics include data integrity and ALCOA++ principles, roles and responsibilities, system validation, user management, security, audit trails, electronic signatures, data protection, cloud solutions and database decommissioning. It applies to systems such as electronic medical records, electronic case report forms, electronic clinical outcome assessment and patient‑reported outcome tools, wearables, interactive response technologies, electronic informed consent, electronic trial master files, clinical trial management systems, pharmacovigilance databases and artificial intelligence‑based tools, and replaces the 2010 Reflection Paper on electronic source data.

An online research data management guide maintained by University College London (UCL) Library Services, covering how to manage the outputs of research projects across the full data lifecycle. It supports researchers from planning to project closure, including writing a data management plan, organising and storing data securely during a study, and choosing where and how to share or preserve data at the end. The guide addresses key issues such as data protection, copyright, long‑term preservation, and compliance with institutional and funder expectations. Relevant for clinical investigators who need to handle research data systematically, protect participants’ information, and meet open research and data sharing requirements.

A web‑based research data management toolkit for life sciences, developed and maintained by the ELIXIR network. It guides researchers and data stewards in managing research data across the full data lifecycle in line with FAIR (Findable, Accessible, Interoperable, Reusable) principles. Content is community‑driven, with contributors from many European countries, and focuses on practical, domain‑specific and role‑based guidance. Particularly relevant for biological and health research, including investigator‑initiated clinical studies that need to ensure that data are well documented, reusable and compliant with funder expectations.

An online Data Sharing Toolkit, developed within the EDCTP Knowledge Hub and hosted by The Global Health Network, that collates practical information and resources on sharing clinical and health research data. It brings together guidance on data management basics, step‑by‑step data sharing workflows and a repository finder tool to support researchers in preparing, documenting and depositing datasets in appropriate repositories. 

World Health Organization policy and implementation guidance on the sharing and reuse of health‑related data for research purposes. It clarifies how health data collected under the auspices of WHO technical programmes may be reused and onward shared for research, in both emergency and non‑emergency situations. The policy covers research data generated directly by WHO, research funded by WHO and the reuse of other health‑related data for research when WHO is involved. It sets objectives and principles for data sharing that are equitable, ethical, efficient and consistent with FAIR (Findable, Accessible, Interoperable, Reusable) data practices, and is accompanied by implementation guidance to support the development of data management and data sharing plans for each dataset for which WHO is responsible.

ECRIN’s Data Centre Certification Programme identifies non‑commercial clinical trials units that can demonstrate safe, secure, compliant and efficient management of clinical research data. The programme is built on a published set of data centre standards that cover information technology infrastructure, data management processes, treatment allocation and statistical programming. These standards are used both for independent on‑site audits and as a practical reference for good clinical data management practice.