Guideline on Computerized Systems and Electronic Data in Clinical Trials

10 March 2023 – the EMA published the guidance on computerized systems and electronic data in clinical trials.

This guideline will describe some generally applicable principles and definition of key concepts. It also covers requirements and expectations for computerized systems, including validation, user management, security, and electronic data for the data life cycle. Requirements and expectations are also covered related to specific types of systems, processes, and data.

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