Appendixes | Clinical | Comment Report

Comment Report
This process generates a document of study comments obtained from source data pertaining to each subject.
What do I need?
This process requires the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) and the CO 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
the Comments ( COVAL ) and comment Sequence Number ( COSEQ ) variables.
Running this process generates a pdf or rtf file of the comments contained within the CO domain. Refer to the Comment Report output documentation for detailed descriptions and guides to interpreting your results.