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- The ALCOA, or ALCOA-C principle is the acronym applied to the principle of supplying good data quality from source documents in clinical trials. This covers both electronic and paperwork sources of data and is applied as a set of standards by the FDA and the EMA.
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Oct 5, 2022 · The ALCOA, or ALCOA-C principle is the acronym applied to the principle of supplying good data quality from source documents in clinical trials. This covers both electronic and paperwork sources of data and is applied as a set of standards by the FDA and the EMA.
Dec 15, 2021 · ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate) - SOM Clinical Research Glossary. Acronym for a number of attributes or dimensions that are considered of universal importance for data integrity of source data and the records that hold those data. These include that the data and records be:
When you think about ALCOA-C, you first need a clear definition of source data. According to the FDA, is any medical record or form kept for a participant before, during, or after the clinical trial procedure. The FDA and other regulatory bodies prioritize the quality of source documents because these documents let monitors investigate and ...
Accurate, consistent and real representation of facts. C. omplete. The information should be complete (i.e., to answer who, what, when, where, why, and how). - All of the elements of the acronym ALCOA must be applied to both paper and electronic source data, and the records that hold that data. Serving as evidence of the events that took place ...
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- Attributable. Is it traceable to a person, date, and subject visit? When documenting data on paper, every written element needs to be traced back to the authorized individual responsible for recording it.
- Legible. Is it clear enough to read? Everything written on paper must be easy to read and recorded in a permanent medium – not in pencil. Handwriting must be clear to reduce the likelihood of transcription errors and allow accurate study re-creation.
- Contemporaneous. Was it recorded as it happened? Data should be recorded, signed, and dated at the time of trial conduct, rather than risk an individual recalling the wrong information from memory.
- Original. Is it the first place data is recorded? The source is the earliest record – the first place data is documented. If corrections or revisions need to be made, changes shouldn’t obscure prior entries.
According to the FDA data integrity guidelines, data should be Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA). This acronym has been around since the 1990s. The FDA coined it to ensure that data security and integrity are maintained.
Apr 22, 2020 · A common acronym in clinical research is ALCOA-C which stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. The purpose of ALCOA-C is to ensure that source documents are up to standard throughout every study.
