Processes | 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.
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.