Concomitant medications (con-meds) are any prescription or over-the-counter drugs and supplements taken in addition to an investigational therapy by a study subject. Many study protocols require capturing con-med usage into subject’s study record. This can be an extremely difficult task as it relies on the honest and accurate reporting by subjects as well as detailed review of medical records. It is not enough to simply submit the name of a medication, as most con-med reports typically require dosage, frequency, and duration of usage. Often, multiple con-med entries will need to be created in the study record for the same medication if the dosage changes or if the subject stops and restarts the medication. This can potentially lead to dozens or more errors of data point entries for a single study subject. So why are con-meds so important in research trials and how can researchers ensure that con-meds are being accurately reported?

