By Sophie Hammer
You might have heard of the concept of ALCOA, but do you know what that means exactly? ALCOA is an acronym meaning Attributable, Legible, contemporaneous, original and Accurate. Often, international teams use it much but this is less the case in France, is it really a new concept? Here are some explanations about this new word: where does it come from? What does it mean concretely and how to apply it?
I. ALCOA, where does it come from?
From US, yes! The acronym ALCOA was invented by Stan Woolen early in 90’s. The story goes that Dr. Woolen had to make numerous presentations in the FDA’s division in which he worked. Not being accustomed to public speaking, Dr. Woolen implemented several techniques to remember what to say and organize his speech. One of his techniques was using acronyms. One day while he was missing a place in one of his slides, he introduced the acronym to remember to mention this notion, ALCOA was easy to remember because it is the name of a company known to United States. The assembly asked what this « jargon of the government » was and from that day, Dr. Woolen re-explained repeatedly that concept.
The notion of ALCOA, meanwhile, appears for the first time in a text of good laboratory practice of the Food and Drug Administration (FDA), 21 CFR 58.130, parts c and e. If you want to know more, you can find the text here.
To date, the acronym ALCOA is not listed as such in Good Clinical Practice (GCP) of the International Conference of Harmonization (ICH) or French GCP, however, they are essential notions that are there.
The European Medicines Agency, EMA, has meanwhile, added four other concepts in this acronym: Complete, Consistent, Enduring, Available When needed (ALCOACCEA) in a reflection paper on electronic data sources and transcribing data sources in an electronic system (here)
II. The ALCOA, what is it?
As stated above, Alcoa means Attributable, Legible, Contemporaneous, Original and Accurate, that is to say: Attributable, readable, contemporary, original and accurate.
a. Attributable:
Attributable means that you must find the source of a data. You must be able to find who has observed and collected the data, when this data was collected, as well as the source of the data itself: the patient.
Similarly, in case of correction, the person who made this correction must be identified. Obviously, the intervenor must be authorized by the investigator to make these changes to source documents via the delegation form of tasks.
We find this notion in the French GCP:
– Concerning the medical records of patients:
1.19. Dossier of the person consenting to research or medical record […] Elements in the medical record of a patient hospitalized in a health facility are defined in Articles R. 1112-2 and R. 1112-3 of the code of public health.
And Article R. 1112-3 of the Code of Public Health says, « Every piece of the file is dated and includes patient ID with name, first name, date of birth or identification number, and the identity of the health professional who has produced or collected information. Medical prescriptions are dated with time indication and signed; name of the signatory doctor is mentioned in legible characters. »
– Regarding data modification
4.9.3. Any modification or correction to a CRF is dated and initialed by the investigator or a person designated by him, and should not obscure the original entry (that is to say an audit trail should be stored); reasons of modification are given if necessary. This applies to modifications and corrections made whatever material (see 5.18.4 [n])
b. Legible
The data must be readable and stay like this in long term. The data should be collected with a material that allows the long-term readability.
The French GCP also evoke it repeatedly:
4.9.1. The investigator shall ensure that the data provided to the promoter in case report forms and required reports are collected and recorded more and more, accurately, completely and legibly.
- Essential Documents relating to biomedical research […]: The means used to store essential documents must allow those documents to remain complete and legible throughout the required retention period.
c. Contemporaneous
The data must be contemporary, this means that the time when the data is recorded must match the time when the data is collected. To document this, of course, the documents must include a date. If the data is corrected or collected later on, this must be justified adequately.
The French GCPs indicate well: 4.9.1. The investigator shall ensure that the data provided to the promoter in case report forms and required reports are collected and recorded more and more.
d. Original
The data must be original, that is to say, they must be from the first record of the data: the most reliable. When copying, the copy must be certified by the person who has made the copy so that to document the accuracy of data.
You will notice without doubt this is the very definition of the source documents in the French GCP:
1.17. Source Documents: Original documents, data and records relevant to the research
e. Accurate
Finally, the data must be reliable. Obviously, the data must be truthful. This reliability is checked during quality control mentioned by the GCP:
4.9.1. The investigator shall ensure that the data provided to the promoter in case report forms and required reports are collected and recorded more and more, accurately, completely and legibly.
5.1.3. Quality control must be implemented at all stages of data processing to ensure that they are reliable and have been processed correctly.
f. Complete, Consistent, Enduring, Available When needed…
The EMA has completed the ALCOA adding that the documents should be complete at the day of the document review, consistent, sustainable and available when needed as part of the monitoring, audits or inspections.
III. How to apply ALCOA daily as CRA?
All study documents should be consistent with the notion of ALCOA: source documents, essential documents and documents in the CRFs, whether electronic or on paper.
First, the CRA verifies that data are attributable during the review of the source data, he verifies that the data was collected by a person authorized to participate in the study and, therefore, included in the delegation sheet of tasks. To be verified, these data must necessarily contain the trace of the person who drafted it. Similarly, each source document must contain the patient identifier and the date of the data.
When reviewing source documents, paper CRFs and essential documents, the CRA ensures that data is not crossed out or hidden, that is to say legible. In this case, he retrains the investigator and his team to correction procedures: bar the data by ensuring that it remains readable, exclaim the correct data beside, initial and date. The French GCPs tell us that the reason for the correction should be given if necessary. For example, if the correction is made several months after the initial collection of the data, the corrector must justify this correction (contemporary data). If electronic source documents, an audit trail must be set up to monitor the corrections, their author, date and reason, it is a point to check at the beginning of the study.
The CRA must also ensure that the data is readable: the pencil is proscribed on the study documents or medical records because it can be erased with an eraser or simply by time! If data have been written in pencil, the document should be photocopied, dated, signed, certified and preserved with the original.
The CRA verifies, if possible, that the data was transcribed in a reasonable period after the issuance of the data, that is to say, that the entry in the electronic CRF was made in the time required by procedures of the promoter, if applicable, and documents the reason in the monitoring report for delay.
Finally, the CRA verifies the reliability of the electronic CRF data when monitoring quality of source data. To some extent, the CRA also verifies the reliability of the source documents, it can unfortunately happen that an investigation team member to cheats. This case remains thankfully rare.
The ALCOA is a set of rules to be applied so that data from a clinical trial are the most accurate available and can be verified long after the end of the trial. Although this system may be perceived as restrictive by some, it is a good habit to get so that the trial goes well. The ALCOA concerns not only the investigative teams: CRAs, CSCs, DMs, project managers, statisticians, project assistants, CRF editors, the whole team is involved.
To go further, you will find below the sources used to write this article:
http://www.southernsqa.org/newsletters/Summer10.DataQuality.pdf
http://forteresearch.com/news/paper-electronic-source-data-meet-alcoa/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121265/#CIT2
Update of June 29, 2020: The text of the ICH has been updated and has come into effect, since June 14, 2017, we are at version ICH E6 (R2). In point 4.9.0, ALCOAC has been added (Attributable, legible, contemporaneous, original, accurate and complete).
For more information on the text, click here : https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf
