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.

Operating System and Release Information

Product Family	Product	System	Product Release		SAS Release
			Reported	Fixed*	Reported	Fixed*
SAS System	SAS Clinical Standards Toolkit	Microsoft Windows Server 2003 Standard Edition	1.3	1.4	9.2 TS2M3	9.3 TS1M0
		Microsoft Windows Server 2008	1.3	1.4	9.2 TS2M3	9.3 TS1M0
		Microsoft Windows XP Professional	1.3	1.4	9.2 TS2M3	9.3 TS1M0
		Windows 7 Enterprise 32 bit	1.3	1.4	9.2 TS2M3	9.3 TS1M0
		Windows 7 Home Premium 32 bit	1.3	1.4	9.2 TS2M3	9.3 TS1M0
		Windows 7 Professional 32 bit	1.3	1.4	9.2 TS2M3	9.3 TS1M0
		Windows 7 Ultimate 32 bit	1.3	1.4	9.2 TS2M3	9.3 TS1M0
		Windows Vista	1.3	1.4	9.2 TS2M3	9.3 TS1M0
		Solaris for x64	1.3	1.4	9.2 TS2M3	9.3 TS1M0
		Microsoft Windows Server 2003 Enterprise Edition	1.3	1.4	9.2 TS2M3	9.3 TS1M0
		Microsoft Windows Server 2003 Datacenter Edition	1.3	1.4	9.2 TS2M3	9.3 TS1M0

* For software releases that are not yet generally available, the Fixed Release is the software release in which the problem is planned to be fixed.

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SAS supplies a set of sample driver modules to illustrate SAS® Clinical Standards Toolkit functionality using sample data and files provided with the product.

Type:	Problem Note
Priority:	medium

Date Modified:	2013-05-21 15:20:30
Date Created:	2010-10-14 11:53:08