This guideline (which replaces EMA/INS/GCP/454280/2010 Reflection Paper on Expectations for Electronic Source Data and Data Transcribed to Electronic Data Collection Tools in Clinical Trials) describes some generally applicable principles and definition of key concepts. It also covers requirements and expectations for computerised 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.

You can read the guidelines in full HERE.

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