This process aids in the review of study domains for a selected set of subjects meeting specified population , WHERE statement , and Data Filter criteria. It merges the relevant data sets based on their review flag values.This process requires that you have defined a valid study . 1 The study must include the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) and domain data sets from the Study Data Tabulation Model ( SDTM , v3.1.1). SDTM domains include Adverse Events ( AE ), Concomitant Medications, ( CM ), Demographics ( DM ), Disposition ( DS ), ECG Test Results ( EG ), Exposure ( EX ), Laboratory Test Results ( LB ), Medical History ( MH ), and Vital Signs ( VS ).The output of this process includes data tables with records color-coded by record-level review flags. Refer to the Domain Viewer output documentation for detailed descriptions and guides to interpreting your results.
As an optional step before running this process, you can run Manage Studies to perform a comparison between two snapshots. Doing so highlights new and modified records.