%cstutilreportaddcomment is specifically designed to add descriptive comments to a findings report, such as explaining why a variable like AESTDY is missing based on clinical knowledge (e.g., ‘Event occurred post-study’). The other macros are for building messages, retrieving message text, or generating check reports, not for adding custom derivation comments.

In the CST reporting framework, a ‘Warning’ indicates a potential issue that should be reviewed—often relating to best practices or sponsor-specific standards—but it does not represent a fatal error or a direct violation of foundational SDTM rules (which would be an ‘Error’). It signals that the data may require attention but does not strictly invalidate the dataset’s compliance.

The correct approach is to place sponsor-specific extensions, like custom controlled terminology, within the study-specific standards library structure (e.g., /terminology). This allows the toolkit to prioritize and use these study-specific terms during validation without altering the global, CDISC-provided standards. This maintains a clean separation between foundational and sponsor-specific metadata.

The _cstSubType parameter is used to specify a subset of checks within a standard. For SDTM validation, you can set _cstSubType to a specific domain (like ‘TA’) to run only the checks relevant to that domain’s structure, keys, and variables. _cstStandard and _cstStandardVersion define which standard (e.g., SDTM) and version to use, while _cstType defines the broad category of validation (e.g., ‘checks’).

The cstcheckresults table contains the detailed results of each individual check performed, including columns for checkid, resultid (which holds the result status like ‘Error’), sourcedataset, and other key details. This table is the primary source for aggregating findings by check, result type, and dataset. cstresults is a higher-level summary, cstcheckmetrics has performance data, and cstglobalmessages contains system messages.

The foundational step is creating and assigning a study-specific control dataset. This dataset, referenced through the CSTCONTROL library, defines all the critical paths (like source data, target libraries, standards libraries) and settings for the study. All subsequent toolkit macros rely on the paths and parameters defined here to locate the correct files and execute properly in the context of the specific study.

If ‘MILD’ is valid per the current CDISC CT, but the validation reports it as invalid, the most common cause is that the standards library referenced by the validation run contains an older version of the terminology. The toolkit validates against the terms stored in its referenced standards library (e.g., sasGlobalLibrary/terminology), not against a live online source. An update to this library is required.

The toolkit is designed to be extended via user-defined checks. The correct method is to register your custom check (DATA step, macro, or PROC) in the appropriate metadata files (e.g., tables in the standards library) and then set _cstEnableUserChecks=1 when calling the validation macro. This integrates your check seamlessly into the standard workflow, ensuring it runs, logs results, and appears in reports alongside standard checks.

The define.xml generation process in the CST uses metadata datasets (srcmeta, trgmeta, docmeta, etc.) to create the specification. It does not use the actual clinical data files (like ae.xpt) as a direct input. The metadata describes the structure, variables, controlled terminology, and other attributes; the define.xml is a metadata document, not a summary of the actual data values.

%cstutilreportaddcomment is specifically designed to add descriptive comments to a findings report, such as explaining why a variable like AESTDY is missing based on clinical knowledge (e.g., ‘Event occurred post-study’). The other macros are for building messages, retrieving message text, or generating check reports, not for adding custom derivation comments.0