Reference:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOA

Document information
Reference	EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
Validity area	EU
Scope(s)	G
Document name	EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials
Version / Revision	2023
Status	Current
Document type	Official guideline
Language(s)	EN
Description	EMA/INS/GCP/112288/2023 Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on computerised systems and electronic data in clinical trials
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 4 — Unit 4.2.3
Scope	G
Document part	4.5 ALCOA
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Data integrity, Metadata, Audit trail

Content

4.5. ALCOA++ principles A number of attributes are considered of universal importance to data. These include that the data are:

Attributable Data should be attributable to the person and/or system generating the data. Based on the criticality of the data, it should also be traceable to the system/device, in which the data were generated/captured. The information about originator (e.g. system operator, data originator) and system (e.g. device, process) should be kept as part of the metadata.

Legible Data should be maintained in a readable form to allow review in its original context. Therefore, changes to data, such as compression, encryption and coding should be completely reversible.

Contemporaneous Data should be generated by a system or captured by a person at the time of the observation. The time point of the observation and the time point of the storage should be kept as part of the metadata, including the audit trail. Accurate date and time information should be automatically captured and should be linked and set by an external standard.

Original Data should be the original first generation/capture of the observation. Certified copies can replace original data (see section 6.5. on certified copies). Information that is originally captured in a dynamic state should remain available in that state.

Accurate The use of computerised systems should ensure that the data are at least as accurate as those recorded on paper. The coding process, which consists in matching text or data collected on the data acquisition tools to terms in a standard dictionary, thesaurus, or tables (e.g. units, scales), should be controlled. The process of data transfer between systems should be validated to ensure the data remain accurate. Data should be an accurate representation of the observations made. Metadata should contain information to describe the observations and, where appropriate, it could also contain information to confirm its accuracy. [...]