This problem has been resolved in SAS® Clinical Standards Toolkit 1.5, see this usage note (includes link to the user documentation to resolve this problem):

Usage Note 49980: SAS® Clinical Standards Toolkit 1.5 - A Round Trip Exercise Involving the CDISC SDTM and CDISC CRT-DDS Standards

SAS supplies a set of sample driver modules to illustrate SAS® Clinical Standards Toolkit functionality using sample data and files provided with the product. Selected CDISC-SDTM 3.1.1 driver modules do not produce correct results when run against the SASCSTDEMODATA sample study.

The incorrect results occur because the driver modules share the same CDISC-CRTDDS 1.0 metadata derived from a CDISC-SDTM 3.1.2 study. This issue involves the following driver modules, deployed to (SAS 9.2 path; SAS 9.1.3 path may differ slightly) !sasroot/../../SASClinicalStandardsToolkitSDTM311/1.3/sample/cdisc-sdtm-3.1.1/sascstdemodata/programs:

Each of these demonstrates part of the process to build a CDISC-SDTM study based on a DEFINE.XML file. The current sample define file, deployed to (SAS 9.2 path) !sasroot/../../SASClinicalStandardsToolkitCRTDDS10/1.3/sample/cdisc-crtdds-1.0/sourcexml/define.xml, is built from the SDTM 3.1.2 sample study.

Note that the equivalent CDISC-SDTM 3.1.2 drivers correctly demonstrate the derivation of a CDISC-SDTM study from a CDISC-CRTDDS 1.0 DEFINE.XML file.

To enable the CDISC-SDTM 3.1.1 drivers identified above to function properly against the sample data, the following changes are required:

1. The supporting SASReferences data set must point to a DEFINE.XML file built from a CDISC-SDTM 3.1.1 study. Such a file is provided in (SAS 9.2 path) !sasroot/../../SASClinicalStandardsToolkitCRTDDS10/1.3/sample/cdisc-crtdds-1.0/sourcexml/define311.xml. This file reference is provided in the TYPE="externalxml" SASReferences record.

2. Modify the link to each domain transport file. This should happen at both the SAS metadata level (Reference_Tables and Source_Tables XMLPATH column) and in the XML (each specification, where XX is the domain name). This metadata should point to a SDTM 3.1.1 specific transport subdirectory. If unmodified, the create_sasdatafromxpt.sas driver will incorrectly read the transport files found in (SAS 9.2 path) !sasroot/../../SASClinicalStandardsToolkitCRTDDS10/1.3/sample/cdisc- crtdds-1.0/transport, which were created from SDTM 3.1.2 source data.

3. The create_sourcemetadata.sas driver reads source information from (SAS 9.2 path) !sasroot/../../SASClinicalStandardsToolkitCRTDDS10/1.3/sample/cdisc-crtdds-1.0/deriveddata, which by default was populated from running the CDISC-CRTDDS 1.0 create_sascrtdds_fromxml.sas driver module against a DEFINE.XML file built from SDTM 3.1.2. Instead, the create_sascrtdds_fromxml.sas driver must be run against DEFINE311.XML first, repopulating the (SAS 9.2 path) !sasroot/../../SASClinicalStandardsToolkitCRTDDS10/1.3/sample/cdisc-crtdds-1.0/derivedmetadata and deriveddata folders with SDTM 3.1.1 study information. Alternatively, SDTM version-specific subdirectories (such as deriveddata/sdtm311 and deriveddata/sdtm312) may be used and referenced in the SASReferences data set.

4. The create_formatsfromcrtdds.sas driver suffers the same problems and will benefit from the same remedies as described above for the create_sourcemetadata.sas driver.

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