| Cally Davidson, Eric Howard |
Accurate and complete mapping of raw clinical data to Study Data Tabulation Model (SDTM) domains is essential for
high-quality regulatory submissions. A common oversight occurs when raw datasets contain observations that appear
only later in the study, such as pregnancy data within the RP domain, leading to incomplete or missing SDTM domains if
initial mapping was based on earlier data snapshots. This paper highlights a SAS macro, called search_raw, developed
to automate the quality control (QC) process by ensuring all relevant raw data sources with observed records are mapped
to SDTM domains. The macro checks for the presence of data from raw sources in the .SAS logs and summarizes SDTM
input source datasets, while flagging any unmapped data streams. The RP domain serves as a case study, illustrating
how subjects with no pregnancies reported early in the study can be missed if mappings aren't revisited. By automating
these checks, the macro enhances traceability, reduces manual review, and ensures complete and compliant SDTM
deliverables. |