Validation Process :: SAS(R) Clinical Standards Toolkit 1.5: Getting Started

Do I Have to Run All of the SAS Validation Checks for SDTM?

No. The SAS Clinical Standards Toolkit offers the full set of CDISC SDTM 3.1.2 validation checks in the global standards library data set called validation_master found in the global standards library directory/standards/cdisc-sdtm-3.1.2-1.5/validation/control directory.

This set of checks represents an amalgamation of WebSDM, OpenCDISC, and SAS checks. Some checks assess structural (metadata) compliance, and other checks evaluate specific data sets, columns, and data values at the “cell” level.

For any given validation process, the SAS Clinical Standards Toolkit expects that you have defined and referenced (in SASReferences, with type/subtype set to control/validation) a run-time set of checks that might be some subset of the validation_master checks. You have the option of both creating this subset and ordering the checks to be run.

The run-time set of checks might well change over time. For example, once the metadata structure of the domains is confirmed, those checks do not need to be run again.

See “Building a Validation Process” in Chapter 6, “Validation,” in the SAS Clinical Standards Toolkit: User's Guide.

Can I Run a Validation Process in the SAS Clinical Standards Toolkit on Multiple Studies Simultaneously?

Yes. The SAS Clinical Standards Toolkit offers several distinct methodologies that support validating multiple studies. However, these methodologies depend on your data accrual processes and workflow. It is important that you maintain relationships between the source study data and the metadata that the SAS Clinical Standards Toolkit requires. Each column in each data set in each study must be uniquely identifiable.

See “Case Study 7: Validation of Multiple Studies” in Chapter 6, “Validation,” in the SAS Clinical Standards Toolkit: User's Guide.

If I Disagree with or Choose to Modify the Codelogic of a Specific Validation Check, What Needs to Be Done?

Create your own copy of the validation_master data set for a specific standard (which might be the run-time validation_control data set). Then, make the changes to the copy’s validation check metadata, including codelogic.

If you believe that the codelogic provided by SAS is in error and you want SAS to correct the error, report the problem through normal Technical Support channels. Approved updates become available with a subsequent hot fix or release of the SAS Clinical Standards Toolkit.