ABSTRACT
Some kinds of data is collected as free text but must eventually be grouped together into like terms for review and analysis. The most common examples of this kind of data is adverse events (AEs), medications, and diagnoses. In all of these cases, the investigator reports a term with little or no guidance on terminology or wording. Yet, to make assessments of the safety of the drug, like terms must be counted or classified together. For example, the AE terms headache, mild headache, and aching head should all be counted as the same kind of event. Similarly, the drugs reported as Tylenol and acetaminophen should be classified as the same drug.
