《Clinical Standards Toolkit》.pdfVIP

Clinical Standards Toolkit The Implementation of Nested Value Level Metadata in the SAS Representation of the CRT-DDS v1.0.0 Model in the SAS® Clinical Standards Toolkit Date: 06/28/2012 Prepared by: CST Development Team 2 The implementation of nested Value Level Metadata in the SAS representation of the CRT-DDS v1.0.0 model in the SAS® Clinical Standards Toolkit Introduction The SAS Clinical Standards Toolkit [1] supports reading, writing and validation of define.xml files that conform to the CDISC CRT-DDS v1.0.0 standard [2]. This capability has been available in the Toolkit since version 1.3. The SAS Clinical Standards Toolkit can read a CDISC CRT-DDS 1.0 XML file and convert the information in the define.xml file into a SAS representation of the CRT-DDS model. For CDISC CRT-DDS 1.0.0, this means that 39 data sets are derived from the define.xml element and attribute structure. Appendix 1 lists these data sets with a short description. Typically a define.xml file contains the following content:  Domain Level metadata  Variable Level metadata  Value Level metadata  Code List metadata  Computational Methods metadata  Documents metadata (aCRF, Supplemental Data Definitions) This note describes how the SAS Clinical Standards Toolkit implements (nested) Value Level Metadata in the SAS representation of the CRT-DDS model. This note does not describe a process to populate the SAS data sets that represent the CRT-DDS data model. The Toolkit User Guide (see documentation section at [1]) describes how some of these SAS data sets can be populated from SDTM source metadata. Also, a paper presented by SAS Institute describes how custom code can be cre