The ALCOA+ principles are a catalogue of criteria for trustworthy records and data in regulated activities. ALCOA stands for attributable, legible, contemporaneous, original and accurate: data must be attributable to a person or system, legible, recorded contemporaneously, original and accurate. The extension adds requirements that keep data usable and verifiable throughout its entire lifecycle.<\/p>\n
Attributable means that it is clear who made an observation, entered a value or approved a change. Legible requires that entries and associated metadata remain understandable throughout the retention period. Contemporaneous means that the record is made at the time of, or as close as possible to, the actual observation. This avoids subsequent reconstruction from memory.<\/p>\n
Original refers to the first permanent source record or a certified copy whose completeness and accuracy have been demonstrated. Accurate requires that the record accurately reflects the observation in factual terms. When a correction is made, the original entry must not be obscured; the change must be traceable and, where necessary, explained. These principles apply not only to eCRF data, but also, for example, to laboratory findings, informed consents, training records and electronic signatures.<\/p>\n
The extension of ALCOA+ is described using complete, consistent, enduring and available when needed. Complete means that all relevant information, including changes, reasons and associated metadata, is present. Consistent means that data, timelines and documentation are not contradictory and are generated according to defined procedures. Enduring requires suitable, durable retention, while available ensures that authorized persons can retrieve the data for review, evaluation or inspection.<\/p>\n
The EMA guideline on computerised systems additionally names traceable and uses the designation ALCOA++. Traceability links the data value and context throughout the lifecycle: origin, processing, transmission and archiving must be able to be reconstructed. ALCOA+ is not a substitute for risk-based quality management. The principles must be implemented in practice in workflows, system requirements, training, reviews and retention rules.<\/p>\n
For paper-based records, this is supported, for example, by traceable correction rules, dated entries and protected archiving. In electronic systems, this is supplemented by unique user accounts, timestamps, authorization concepts, validated functions and verifiable retention of metadata. The design should be based on the criticality of the data and the risks to participant protection and study results. It is regularly reviewed on a risk-based basis.<\/p>\n
ALCOA+ principles and data integrity are closely related, but they are not synonymous. Data integrity is the overarching objective: data should be reliable for the intended purpose and permit correct reporting, verification and interpretation. ALCOA+ instead describes specific quality characteristics by which this objective can be assessed and translated into requirements.<\/p>\n
The difference is evident in an electronic system: a value may be attributable and entered contemporaneously without the system being adequately protected against unauthorized access or its interface being validated. Conversely, validation, access controls, backups and an Audit Trail also support data integrity, but are not themselves ALCOA+ characteristics. Only the interaction of principles, governance and controls ensures the integrity of study data.<\/p>\n
In clinical trials, ALCOA+ principles provide a common lens for reviewing source data, eCRF, central data transfers and essential documents. They help identify weaknesses at an early stage, such as illegible paper documentation, missing time information, unclear access rights or corrections that cannot be traced. ICH E6(R3) requires in particular that source data be attributable, legible, contemporaneous, original, accurate and complete; the EMA expressly applies these expectations to electronic data throughout their lifecycle.<\/p>\n
Full-service CROs such as Mediconomics support the translation of the principles into practical workflows: through eCRF and data flow design, training of trial sites, monitoring, data management and the review of system and process documentation. This includes clear requirements for source documentation and data corrections, risk-based controls for critical data, assessment of Audit Trails, and traceable archiving of study data and metadata.<\/p>\n
What does the plus in ALCOA+ stand for?<\/strong><\/p>\n It supplements the five basic principles with complete, consistent, enduring and available when needed. The EMA guideline additionally emphasizes traceability and therefore refers to ALCOA++.<\/p>\n Is a printout of an electronic record always an original?<\/strong><\/p>\n Not automatically. An original is the first permanent source record. A certified copy may be acceptable for reconstruction and review purposes if its completeness and accuracy have been demonstrated.<\/p>\n Do ALCOA+ principles also apply to automatically transferred data?<\/strong><\/p>\n Yes. For automated data, in addition to origin and timing, interface specifications, validation, metadata, error handling and the traceability of the transfer are particularly important.<\/p>\n The ALCOA+ principles are a catalogue of criteria for trustworthy records and data in regulated activities. ALCOA stands for attributable, legible, contemporaneous, original and accurate: data must be attributable to a person or system, legible, recorded contemporaneously, original and accurate. The extension adds requirements that keep data usable and verifiable throughout its entire lifecycle. The […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-6587","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6587","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6587\/revisions"}],"predecessor-version":[{"id":7512,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6587\/revisions\/7512"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6587"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6587"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory references<\/h2>\n
\n