Additional Metadata Files

The following metadata files can be used for specific tasks. In some cases, the file structures might be unique to the supported or referenced standard. These metadata files are provided by the SAS Clinical Standards Toolkit.

Each standard that supports validation has a Validation Master data set that provides the full set of validation checks defined for that standard. (For a description of the standards.supportsvalidation field, see Metadata/Standards Data Set Structure in the Global Standards Library.) This data set should have the columns as defined in Column Descriptions of the Validation Master Data Set, though additional columns are permitted for user customizations. For each SAS Clinical Standards Toolkit validation process, the set of run-specific checks is captured in a Validation Control data set. The Validation Control data set is identical in structure to the Validation Master data set, but can be different only in the number of records (checks) included. Use of Validation Control SAS views is supported.

Part of the definition of each standard is the itemization of the data tables that define the SAS representation of that standard and version. The reference_tables data set captures table-level metadata about each reference standard data set. The structure of this data set can be standard specific. For example, reference_tables Data Set describes the table metadata for the CDISC SDTM standard. For selected actions, the SAS Clinical Standards Toolkit requires a similarly structured source_tables data set that defines study-specific tables. For example, a SAS Clinical Standards Toolkit validation process compares the study metadata in the source_tables data set with the reference standard metadata in the reference_tables data set.

Part of the definition of each standard is the itemization of the columns in each data table that defines the SAS representation of that standard and version. The reference_columns data set captures column-level metadata about each reference standard column. The structure of this data set can be standard specific. For example, reference_columns Data Set describes the column metadata for the CDISC SDTM standard. For selected actions, the SAS Clinical Standards Toolkit requires a similarly structured source_columns data set that defines study-specific columns. For example, a SAS Clinical Standards Toolkit validation process compares the study metadata in the source_columns data set with the reference standard metadata in the reference_columns data set.

Each SAS Clinical Standards Toolkit validation process can generate a Summary data set that provides a meaningful denominator for most validation checks. The Summary data set enables you to more accurately assess the relative scope of errors that are detected. The generation of this data set is based on validation property settings. This data set can be persisted beyond the SAS session based on SASReferences data set settings. For example, Column Descriptions of the Validation Metrics Data Set describes the metrics metadata for the CDISC SDTM standard, and Sample Validation Metrics Data Set provides sample content for the CDISC SDTM standard.

Sample XSL style sheets are provided with the CDISC CRT-DDS 1.0 standard and the CDISC Define-XML 2.0 standard. A define.xml file can be rendered in a human-readable form (such as HTML) with an appropriate XSL style sheet. These sample style sheets, define1-0-0.xsl for CDISC CRT-DDS 1.0 and define2-0-0.xsl for CDISC Define-XML 2.0, are based on the style sheets provided by CDISC at http://www.cdisc.org/define-xml.

Updated style sheets from CDISC are available at http://wiki.cdisc.org/display/PUB/Stylesheet+Library.

The SAS implementation of the CDISC CRT-DDS 1.0 standard comes with the style sheet define-v1-updated-html.xsl. This style sheet is an updated version of the stylesheet that was used in the updated version of the CDISC SDTM/ADaM Pilot Project Submission Package in 2013. (See http://www.cdisc.org/sdtmadam-pilot-.) Because XSL style sheets are not part of the official CDISC standards, you can use alternative style sheets for display purposes.