Validating controlled terminology in sdtm domains
One glance at the statistics section is enough to assess check results: Detailed statistics include the results of standard and user checks per domain as well as check summaries.
Interactive report allows easy sorting and filtering of messages, severities and other test results.
In the next installment of this series, we’ll cover controlled terminology.
In collaboration with the National Cancer Institute’s Enterprise Vocabulary Services (EVS), CDISC developed standardized lists of terminology to be used with CDISC standards such as SDTM, CDASH, ADa M, and SEND, allowing for consistency throughout the data collection and reporting process.
About a year ago, we (me and some CDISC volunteers) started rewriting all the FDA and PMDA validation rules and some of the CDISC ADa M Validation Checks v.1.3 in XQuery, a W3C standardized language that is at the same time human-readable and machine-executable, and allows to write validation rules that are completely transparent.
This also means that, as the rule is at the same time the implementation, there is no room for different interpretations.
Detailed reports provide an overview of checked domains with user and time stamps, links to used controlled terminology, check details with messages, and statistics.
Results and Reports Test results are presented in different formats for effortless analysis.This is the long-standing “maintenance issue” that was never completely addressed during my term as Chair.There are several cases where modeling approaches adopted in one TAUG changed when a new TAUG was issued, which might not be apparent to those who don’t read every separate publication.The use of XQuery also allow to make the rules themselves completely independent of the software with which the validation is performed.Once the rules are there, anyone can easily write his own software, and all will get the same outcomes when applied to the same set of data. We started this work out of frustration with the way the rules were published and with the way they were implemented by Open CDISC, as: As a consultant, I regularly get questions and complaints from my customers who are generating submission datasets concerning error messages originating from the Open CDISC (now Pinnacle21) Validator software.