Data integrity: ALCOA and ALCOA PLUS

Data integrity is an important means to trace whether the pharmaceutical industry complies with the production. Regulatory authorities are also paying more and more attention to data integrity and have issued relevant specific regulatory guidelines. ALCOA and ALCOA PLUS are more and more used these years. What is ALCOA and ALCOA PLUS? What are ALCOA and ALCOA PLUS principles?

What is ALCOA?

First of all, the ALCOA principle is the basic principle used to evaluate data integrity. It includes five principles: Attributable, Legible, Contemporaneous, Original and Accurate.

It is first from the FDA guideline (Computerized Systems Used in Clinical Investigations -05/2007) technical guidelines for the application of computer systems in clinical trials. And described as below.

There is an increasing use of computerized systems in clinical trials to generate and maintain source data and source documentation on each clinical trial subject. Such electronic source data and source documentation must meet the same fundamental elements of data quality (e.g., attributable, legible, contemporaneous, original,5 and accurate) that are expected of paper records and must comply with all applicable statutory and regulatory requirements.^[1]https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computerized-systems-used-clinical-investigations

What is ALCOA PLUS

Based on ALCOA, the European Medicines Agency (EMA) upgraded it to the ALCOA+CCEA principle in the document “Guiding Principles for Electronic Data Acquisition of Clinical Trials” In 2010.

Later, data integrity developed a supplement to the ALCOA principle, and proposed the CCEA principle, also known as the ALCOA PLUS(ALCOA+) principle, namely Complete, Consistent, Enduring, and Available. Detail described as below.

6.1. General Principles
The elaboration of general principles to be adhered to is of importance since it allows the preparation of guidance that can then be adapted to the specific situation of a particular electronic data capture instrument or to the context in which it is used. The basic concept of source data is that it permits not only reporting and analysis but also verification at various steps in the process for the purposes of confirmation, quality control, audit or inspection. A number of attributes are considered of universal importance to source data and the records that hold those data. These include that the data and records are:
• Accurate
• Legible
• Contemporaneous
• Original
• Attributable
• Complete
• Consistent
• Enduring
• Available when needed^[2]https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-expectations-electronic-source-data-data-transcribed-electronic-data-collection_en.pdf

Data integrity and WHO

May 2016, WHO data integrity with ALCOA and ALCOA PLUS principles as below

ALCOA. A commonly used acronym for “attributable, legible, contemporaneous, original and accurate”.
ALCOA-plus. A commonly used acronym for “attributable, legible, contemporaneous, original and accurate”, which puts additional emphasis on the attributes of being complete, consistent, enduring and available – implicit basic ALCOA principles.^[3]https://www.who.int/

Data integrity and CHINA NPMA

July, 2016, China NMPA announcement on the release of technical guidelines for clinical trial data management. Data integrity princilpe requirement as described as below.

Authenticity, accuracy, completeness and reliability are the basic principles for ensuring the quality of clinical trial data. Good Data integrity should meet the following requirements:
ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate.
ALCOA+: Complete, Consistent, Enduring, Available When Needed.