ABSTRACT

This chapter provides examples of codelist dictionary compliance checks for SDTMs and ADaMs. While standardized controlled terms greatly facilitate review and analysis of the data, data value checks are required since there are many opportunities for unexpected programming or data errors in the SDTM and ADaM creation process. Codelist dictionaries can be created for both SDTMs and ADaMs. Codelist dictionary compliance checks are consistent with Pinnacle 21’s controlled terminology checks. Since ADaMs contain both continuous and categorical variables, additional code is included to exclude unwanted ADaMs or continuous variables for which codelists do not make sense, else the default is to include all ADaMs and variables. Codelist and value-level uppercase checks confirm no lower or proper case controlled terms. Each intermediate dataset is then merged together in the same correct order so that codelists are grouped by ADaMs and variable order.