Recently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials" that replaces the old guideline 'Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials'.
In clinical research, the use of computerized systems has increased significantly because of the development of electronic case report forms, patient-reported outcomes, wearable devices, and artificial intelligence.
It is therefore essential that all parties involved in clinical trials follow guidelines to ensure reliable and high-quality data collection, as well as safeguard participants' rights, safety, and well-being so that a robust decision-making process based on clinical data can be established.
In this guideline, some general principles and definitions of key concepts are explained, along with expectations and requirements for computerized systems, including validation, user management, security, and electronic data for the life cycle of data, as well as other requirements and expectations related to specific types of systems, processes, and data.
This guideline applies to computerized systems (such as instruments, software, and 'as a service'), which are used to create/capture electronic clinical data as well as control other processes that may impact participant protection and data reliability when conducting clinical trials for investigational medicinal products (IMPs).
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