What is meant by “out-of-context” coding?
“Out-of-context” coding means that we code using only the text as contained in the reported term. We do not use any information that is contained in other fields of a data collection form and/or that accompanies the reported term. All information necessary to classify the reported term must be part of the text of the reported term. No information may be assumed, nor may information be added. For example, if the reported term is CHEST PAIN, we would code that in MedDRA to CHEST PAIN even if ANGINA PECTORIS is stated in an accompanying comment field. In order for us to code to ANGINA PECTORIS, it would have to be included in the reported term itself, e.g.
