This process generates a report of total subject clinic attendance over the course of the study, in rtf , pdf , or plain text format.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 ( ARM ), and
• Running this process generates a pdf , rtf , or text file summary of the visits contained within the SV domain. Refer to the Study Visit Report output documentation for detailed descriptions and guides to interpreting your results.