A SAS macro to check SDTM domains against controlled terminology

Abstract

AbstractThe SAS macro presented here allows programmers to check the compliance of SDTM domains with controlled terminology. The macro is based on two input metadata Excel files: one file contains variables/variable groups (e.g. --ACN) together with their corresponding 'codelist' term (e.g. ACN). The other is a reference list of all 'codelist' terms and their controlled terminology values (e.g. DOSE INCREASED, DOSE NOT CHANGED, etc.). Both files are based on the OpenCDISC standard checks for controlled terminology but could be customized to the sponsor's needs. The primary output consists of a list of all values that could not be found in the controlled terminology. Furthermore, the corresponding entries that have not been successfully mapped are also provided. Multiple studies and domains can be checked simultaneously. Therefore, programmers can use the macro at various stages, e.g. during the SDTM development process of a single domain, or when preparing multiple studies for pooling.