DEFINITION :  The Protocol Deviations (DV) domain captures any deviations from the study protocol that occurred during the trial, such as missed visits or incorrect dosages.

PURPOSE : A subject missing a scheduled visit would be recorded in the DV domain, including the reason and impact of the deviation.

STRUCTURE : One record per protocol deviation per subject

TOPIC : DVTERM

KEY VARIABLES : STUDYID, USUBJID, DVTERM, DVSTDTC