Stan Woolen worked for FDA’s Office of Enforcement in the 1990’s, where he was tasked with a great deal of public speaking shortly after he became the Agency Bioresearch Monitoring (BIMO) Program Coordinator. He had years of experience on the ground with GCP and GLP, but found himself in need of shortcuts for helping him organize the tremendous amount of public speaking in front of him. His personal shortcut for tenets of data quality was ALCOA, but when he ran out of space on a slide one day, he included the acronym. After that, it stuck.
ATTRIBUTABLE means that data should be linked to its source. The data should be linked to the person who observed and recorded the data, and traceable to the physical source of the data such as the study, test equipment, analytical run, etc.
LEGIBLE means that the data can be read. In a paper system, that means a permanent ink where changes are made such that both the original entry and the correction are readable. In an electronic system, it means that any electronic copy or facsimile of a paper original must be readable and that typed characters must also be readable.
CONTEMPORANEOUS means that data should be recorded at the time the observation is made or as close to the observation as possible.
ORIGINAL means the first recording of data. For clinical data, “source data” is the term often used. For laboratory data, it is “raw data”. In both cases, the first recording of the data is considered the most accurate and reliable recording.
ACCURATE means “free from error” and “conforming exactly to a standard” according to Merriam-Webster, and conforms to GLP and GCP guidance.
The quality of data is integral to all clinical research and to ensuring that patient care continues to improve with better information and better products. ALCOA was a creative and unique way to provide us with key aspects to maintain data integrity. Thank you Mr. Woolen!