Guideline on computerised systems and electronic data in clinical trials

This guideline is a single, up‑to‑date reference on how sponsors, investigators and service providers should manage computerised systems and electronic data in clinical trials of investigational medicinal products. It explains how to apply risk‑based quality management and data governance so that electronic systems support reliable results while protecting participant rights, dignity, safety and well‑being.

It is organised into core sections on scope, legal background, principles and key concepts, computerised systems and electronic data, plus six annexes. Key concepts include data integrity and ALCOA++, source data, metadata, risk, data capture methods, electronic signatures, data protection and system validation. The main requirements cover system inventories, procedures, training, security, access control and timestamps, as well as data capture and location, transcription and transfers, direct data capture, edit checks, audit trails, data sign‑off, copying and certified copies, cloud solutions, backup, data migration, archiving and database decommissioning.

The annexes give operational guidance on agreements with service providers, validation of computerised systems, user management, information technology security, and specific systems such as electronic clinical outcome assessment, interactive response technologies, electronic informed consent and electronic medical records. In practice, users can review the scope and principles first, then focus on the sections and annexes on validation, data integrity, user management and the relevant system types when selecting or implementing particular tools.