EMA: GCP-Guideline on Computerised Systems and Data Integrity

Last month, the EMA published the final guideline on computerised systems and data integrity in clinical trials, which will enter into force on 10 September 2023. Clinical trials are increasingly using computerised systems for data collection, which come with progressively more complex user surfaces.

The use of data collection tools is not mandatory but can improve and simplify many processes if used correctly. This includes a wide variety of functions to improve data completeness, consistency and unambiguity, e.g. automatic edit checks, automated data transfers, validation checks, assisting information and workflow control.

To ensure the quality and reliability of the examination data as well as the well-being and safety of the examinees the 52-page guideline outlines:

• general definitions and principles of key concepts,
• requirements for computerised systems, including validation, user management and the life cycle of electronic data; and
• expectations for specific types of systems, processes and data.

The guideline also defines the new terminology ALCOA++. The ALCOA principle stands for data that must be accurate, legible, contemporaneous, original and attributable. The amendment refers to the traceability of the data throughout their lifecycle. Changes must be documented as part of the metadata. This ensures traceability and security, e.g. through an audit trail.

The guideline replaces the Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials from 2010.

Source:

EMA: Guideline on computerised systems and electronic data in clinical trials