Today I was reviewing an SDTM of a swiss customer. In my own implementation of the FDA-SDTM rules, violations were reported for some of the "Missing XXX Trial Summary" parameter. I looked into these and found out that all these records had a value for TSVALNF (i.e. TSVALNF populated) but TSVAL was null.
Doing the same with Pinnacle Validator v.2.2 no errors or warnings were however produced. This surprised me as the rule in the FDA spreadsheet and the Pinnacle21 configuration file does not say anything about TSVALNF. For example for rule FDAC276: "Registry Identifier' (REGID) record may be populated in Trial Summay (TS) domain. It is expected for SDTM IG v3.1.2 data and all more recent SDTM versions".
My customer had for this record in TS: TSPARMCD=REGID TSVAL=null TSVALNF=NI.
I do essentially expect that when the FDA obtains an SDTM submission with no value for REGID but with "NI" (not informed) as TSVALNF, it will "not be amused".
Can you please explain how these rules are implemented in Pinnacle21 and what the rationale for these is?
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Today I was reviewing an SDTM of a swiss customer. In my own implementation of the FDA-SDTM rules, violations were reported for some of the "Missing XXX Trial Summary" parameter. I looked into these and found out that all these records had a value for TSVALNF (i.e. TSVALNF populated) but TSVAL was null.
Doing the same with Pinnacle Validator v.2.2 no errors or warnings were however produced. This surprised me as the rule in the FDA spreadsheet and the Pinnacle21 configuration file does not say anything about TSVALNF. For example for rule FDAC276: "Registry Identifier' (REGID) record may be populated in Trial Summay (TS) domain. It is expected for SDTM IG v3.1.2 data and all more recent SDTM versions".
My customer had for this record in TS: TSPARMCD=REGID TSVAL=null TSVALNF=NI.
I do essentially expect that when the FDA obtains an SDTM submission with no value for REGID but with "NI" (not informed) as TSVALNF, it will "not be amused".
Can you please explain how these rules are implemented in Pinnacle21 and what the rationale for these is?