This document was created by experts from the EMA's GCP Inspectors Working Group (GCP IWG). It aims to provide sponsors with a list of requirements and expectations for computerised systems used in clinical trials.
Clinical trials include a growing number and diversity of computerised systems. The complexity of such systems has evolved rapidly over the years, moving from eCRFs and ePRO applications to wearable devices for continuous patient monitoring and the growing use of AI. This shift underlines the need for guidance reflective of the changes in data types and trial types and its influence on the use of computerised systems and the collection of electronic data, taking into consideration the quality and reliability of clinical trial data as well as the rights, dignity, safety, and wellbeing of participants.
This guideline describes generally applicable principles and definition of key concepts related to all computerised systems used in clinical trials. Moreover, it covers requirements and expectations for computerised systems, covering validation, user management, security, and electronic data for the data life cycle. Lastly, requirements and expectations are also covered related to specific types of systems, processes, and data.
3. Legal and regulatory background
4. Principles and definition of key concepts
6. Electronic data
Annex 1 Agreements
Annex 2 Computerised systems validation
Annex 3 User management
Annex 4 Security
Annex 5 Additional consideration to specific systems
Annex 6 Clinical systems
Important notice: This guideline is intended to assist sponsors, investigators, and other parties involved in clinical trials to comply with the requirements of the current legislation (Regulation (EU) No 536/2014,Directive 2001/20/EC and Directive 2005/28/EC), as well as ICH E6 Good Clinical Practice (GCP), regarding the use of computerised systems and the collection of electronic data in clinical trials.