Validation Checks by Standard

The SAS Clinical Standards Toolkit 1.3 provides 150 unique SDTM 3.1.1 validation checks. These checks are derived from four sources.

The CDISC SDTM 3.1.1 Validation Master data set, as defined in the SAS Clinical Standards Toolkit 1.3, contains 257 records. Even though the SAS Clinical Standards Toolkit provides 150 unique CDISC SDTM 3.1.1 checks, there are 257 records in the Validation Master data set. The Validation Master data set is built with multiple instances of the checks. This better supports check selection by version or checksource (that is, WebSDM, Janus, or customer-defined checks), and enables unique check logic and messaging by version or checksource. Of these 257 checks, three are inactive, and 12 are deprecated. Deprecated CDISC SDTM checks generally reflect changes in the WebSDM specifications over time.

The following table provides the distribution of all 257 CDISC SDTM validation checks by the original source of the check (the Validation Master checksource field).

This does not mean that the SAS Clinical Standards Toolkit 1.3 supports 114 different WebSDM checks or 32 unique SAS checks. There are multiple instances of specific checks to handle different sets of SDTM domains. For example, check SDTM0604 assesses whether the sequence numbers (**SEQ) are consecutively numbered. For most domains, this is assessed within each patient (USUBJID). However, the trial summary (TS) domain does not contain patient-level data, so the check logic differs. The Validation Master metadata differs for these two instances of the SDTM0604 check, but reports the same error message for the check.

Information about the 257 records in the CDISC SDTM 3.1.1 Validation Master data set is itemized in Validation Checks. Only selected columns are listed in the appendix. For a full description of a sample Validation Master data set for the CDISC SDTM standard, see Sample CDISC SDTM 3.1.2 Validation Master Data Set Record.

Consider the interrelationships among SAS Clinical Standards Toolkit validation check metadata. All run-time Validation Control data sets, any programs that build or derive from these data sets, corresponding Messages data sets, and the Validation_StdRef data set are examples of how interconnected many SAS Clinical Standards Toolkit metadata files are. For more information about the Messages data set, see Messages. By default, the Validation_StdRef data set is found in the <global standards library directory>/standards/cdisc-sdtm-3.1.1-1.3/validation/control folder.

SAS Clinical Standards Toolkit 1.3 provides 243 unique SDTM 3.1.2 validation checks. These checks are derived from four sources.

The CDISC SDTM 3.1.2 Validation Master data set, as defined in the SAS Clinical Standards Toolkit 1.3, contains 247 records. Even though the SAS Clinical Standards Toolkit provides 243 unique CDISC SDTM 3.1.1 checks, there are 247 records in the Validation Master data set. Of these 247 checks, one is inactive, eight are deprecated, and 18 are not implemented. Deprecated CDISC SDTM checks generally reflect changes in the WebSDM specifications over time. Checks that are not implemented generally involve a comparison of the CDISC SDTM data, metadata, or both with an associated define.xml file. Such cross-standard validation is not supported in the current release of SAS Clinical Standards Toolkit. In the SAS Clinical Standards Toolkit 1.3, the Janus and JanusFR checks were dropped for SDTM 3.1.2.

The following table provides the distribution of all 247 CDISC SDTM validation checks by the original source of the check (the Validation Master checksource field).

Information about the 247 records in the CDISC SDTM 3.1.2 Validation Master data set is itemized in Validation Checks. Only selected columns are listed in the appendix.

Consider the interrelationships among SAS Clinical Standards Toolkit validation check metadata. All run-time Validation Control data sets, any programs that build or derive from these data sets, corresponding Messages data sets, and the validation_stdref data set are examples of how interconnected many SAS Clinical Standards Toolkit metadata files are. For more information about the Messages data set, see Messages. By default, the Validation_StdRef data set is found in the <global standards library directory>/standards/cdisc-sdtm-3.1.2-13/validation/control folder.

The SAS Clinical Standards Toolkit provides check macros that validate the data in the SAS data sets representing CDISC CRT-DDS data. The goal of these check macros is to ensure that all data is correctly specified and that referential integrity is maintained. As a result, a standards-compliant CDISC define.xml file can be produced from these data sets.

The validity of CRT-DDS data is determined by the standard in the form of XML schema definitions. These XML schema definitions must be translated into checks appropriate for the relational and tabular format.

Checks fall into these general categories:

Formats are specified in the standard in one of two ways:

The following table lists the types of checks for CRT-DDS data.

Each check type is assumed to operate on data that exists in a source column in a source data set. A check type can reference one or more parameters that validate the source column data. A parameter can be a character string or a representation of some column other than the source column against which the source column data must be compared.

All character comparisons are case sensitive. Character data is assumed to have been trimmed of leading or trailing white space.

(1) This validation is a combination of checks CRT0101 and CRT0110.

(2) This validation is a combination of checks CRT0100 and CRT0101.

Each check type belongs to one of two categories.

The CDISC CRT-DDS validation checks that are listed in CRT-DDS Validation Checks are performed by comparing the data against a set of expected values. The expected values have been stored in a format catalog (crtddsct.sas7bcat) and a data set (crtddsct.sas7bdat). They can be found in the <global standards library directory>/standards/cdisc-crtdds-1.0-1.3/formats folder. The following table lists the format names and values that are used during CRT-DDS validation. This methodology ensures case-sensitivity compliance required by the XML schema validation. For example, the ItemRangeChecks data set requires an enumeration edit for values such as LT and LE. If mixed case or lowercase values are detected, then the validation check reports an error. In this case, the validation check is CRT0114 , (see CRT-DDS Validation Checks) and it uses the Comp format to report this as an error.

*Value 1 and Value 2 are case sensitive.

The SASReferences data set needs to contain a row for fmtsearch, with SAS libref set to crtfmt and the Filename should refer to crtddsct.sas7bcat.