Abstract

The scope and practice of clinical data management (CDM) have experienced significant change as a result of the paradigm shift from traditional site-based clinical trials to decentralised clinical trial (DCT) models. Decentralisation increases the volume, heterogeneity and necessity for real-time data streaming by adding remote data collection through digital platforms, telemedicine, wearables, electronic patient-reported outcomes and cloud-based systems. In order to guarantee that data integrity, participant safety, privacy and audit traceability are preserved in these digitally enabled contexts, regulatory organisations globally have started updating and strengthening current frameworks.

This article focuses on key guidance from major regulators such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA), the Central Drugs Standard Control Organization (CDSCO), and the Pharmaceuticals and Medical Devices Agency (PMDA), as well as key data integrity and compliance principles, including Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA+), computerised system validation, cybersecurity compliance, vendor oversight, and data privacy requirements.

Building on these, the article examines the development of global regulatory expectations for CDM within DCTs. It reviews strategies that CDM professionals are using, such as risk-based monitoring, Clinical Data Interchange Standards Consortium (CDISC) standardisation, AI-driven data validation and digital governance, and assesses current regulatory barriers and harmonisation gaps. It concludes that maintaining credible, moral and future-ready CDM methodologies for DCTs will require regulatory flexibility, technical validation and comprehensive worldwide harmonisation.