The Study Visits process generates a graphical display and tabulation of study visit attendance.This process requires the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) and the Subject Visit ( SV ) domain data set from the Study Data Tabulation Model ( SDTM , v3.1.1). Required variables include:
• the planned treatment (intent-to-treat) for each subject ( TRT01P ), or the description of the planned treatment arm , and
• The output generated by this process is summarized in a tabbed report. Refer to the Study Visits output documentation for detailed descriptions and guides to interpreting your results.