Validating and documenting CDISC datasets with SAS® BASE — the SAS clinical standards toolkit

AbstractThe SAS Clinical Standards Toolkit provides a framework for validating and documenting CDISC-compliant data. It is a free add-on package for SAS software available under Microsoft Windows and UNIX. At present, it contains the validation of datasets according to the SDTM model (inclusive of published WebSDM™ and Janus checks) plus the generation of a data definition document following CRT-DDS (define. xml) for the submission. As all metadata and rules reside in SAS tables, other standards or new versions of existing standards can be retrofitted. To begin with, this paper will outline the meaning of such a tool within the scope of CDISC-compliant data management. Following that, the concept of the SAS Clinical Standards Toolkit will be presented and some examples for usage and results will be given. Finally, the adaptability of the tool will be expanded upon and some practical hints will be given.