Research Article

Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies

Figure 2

A snapshot of PMSST while the researcher defines a data collection set schema. On the right hand side, domains of SDTM form a circle; if selected, then CDEs of that domain form the circle. On the left hand side, a schema item “Date_HbA1C_Average1YBeforeACS” is created out of 4 SDTM elements. Below that, a list of other schema items is shown.