Rule FDAC047 / SD0086

May 18, 2016

Either rule FDAC047/SD0086 "SUPPQUAL duplicate records" is wrong or I misunderstand the first part of it stating "All SUPPQUAL Domains records are associated with a single parent record". There are so many examples (also in the SDTM-IG) where one SUPPxx record has many parent records - see e.g. "Section 8.4.3 SUPP-- Examples" in the latest SDTM-IG (3.2), where e.g.:
"Example 3:
This is an example of how the language used for a questionnaire might be represented. The parent domain (RDOMAIN) is QS, and IDVAR is QSCAT. QNAM holds the name of the Supplemental Qualifier variable being defined (QSLANG). The language recorded in QVAL applies to all of the subject’s records where IDVAR (QSCAT) equals the value specified in IDVARVAL. In this case, IDVARVAL has values for two questionnaires (SF36 and ADAS) for two separate subjects. QVAL identifies the questionnaire language version (French or German) for each subject."

Forums

Thanks Sergiy.

But I still have problems what your answer exactly means. Is the (first part of the) rule correct or wrong?
If I analyze the rule description carefully, I think this is not one rule, it are three:
- the first rule "All SUPPQUAL Domains records are associated with a single parent record" however is incorrect
- the second rule "All SUPPQUAL Domains records must have a unique combination of Study Identifier (STUDYID), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR), Identifying Variable Value (IDVARVAL) and Qualifier Variable Name (QNAM) variable value" is correct.
- the third rule: "For all SUPPQUAL domain record all The QNAM variable should be unique for each parent record" is confusing. I still have the impression that the sentence alone is syntactically incorrect. I also wonder whether this rule is not already covered by the second rule. In that case, this third rule would be unnecessary.

So the whole rule could then be limited to "All SUPPQUAL Domains records must have a unique combination of Study Identifier (STUDYID), Unique Subject Identifier (USUBJID), Identifying Variable (IDVAR), Identifying Variable Value (IDVARVAL) and Qualifier Variable Name (QNAM) variable value".

The more I look at some of these rules, the more I have the impression that these are the result of a "complaint box" hanging in the offices of the FDA. Someone at the FDA, unexperienced in how to develop precise and concise rules, then took all these complaints and tried to compile these into a set of rules. The result is not the best.