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:

•

USUBJID ,

•	a treatment variable (the actual treatment received by each subject ( TRT01A ),

•	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.

Output/Results

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.