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Using the SAS ® Clinical Standards Toolkit 1.5 to import CDISC ODM files
| Content Provider | Semantic Scholar |
|---|---|
| Author | Jansen, Lex Philip |
| Copyright Year | 2013 |
| Abstract | The CDISC Operational Data Model (ODM) is a vendor neutral, platform independent XML format for interchange and archival of clinical study data. The model represents study metadata, administrative metadata, reference data and subject data associated with a clinical trial. The ODM format is defined by an XML schema and a specification. The SAS ® Clinical Standards Toolkit (CST) is a framework of SAS macros, metadata and configuration files to support clinical research activities. The CDISC ODM standard is one of the standards that are supported by CST. To enable ODM support, SAS has defined a relational data model that represents the ODM model as SAS data sets. This paper provides an introduction to the structure and content of ODM files and shows how the SAS Clinical Standards Toolkit supports: Reading ODM files. Schema level validation of an ODM file Validating structure and content of the SAS representation of ODM Extraction of clinical data and reference data into SDTM SAS data sets Importing CDISC NCI Controlled Terminology ODM files The paper also looks at the inner workings and underlying technologies of the SAS Clinical Standards Toolkit with respect to XML based standards. |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | https://www.lexjansen.com/pharmasug/2013/HT/PharmaSUG-2013-HT06-SAS.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
