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SD1306 - The TDIGRP Trial Summary Parameter is not provided with TSVAL equal to null, when HLTSUBJI parameter equals 'Y'
Your assessment is correct
Thank you for your post. Rule SD1306 is based on CDISC SDTM conformance rule CG0272, which states: Rule: TSVAL = null; Condition: TSPARMCD = 'TDIGRP' and record exists where TSPARMCD = 'HLTSUBJI' and TSVAL = 'Y'.
Pinnacle 21 has implemented this rule exactly as it is written by CDISC, while communicating to them our concerns, which are the same as yours. Hopefully in the next release of the conformance rules, this is clarified.
You are correct that there are two options at the moment, until this conformance rule is clarified by CDISC, and I would assume both options are sufficient.
SD1306 - The TDIGRP Trial Summary Parameter is not provided ...
I.m.o. it is a bit too easy to point the finger to CDISC here, especially as many of the FDA rules have their own interpretation of the SDTM-IG and in a number of cases even are in contradiction with the CDISC rules.
For me, the CDISC rule is perfectly clear: when TSPARMCD='HLTSUBJI' and TSVAL='Y', then either there should be no TSPARMCD='TDIGRP' row, OR, when there is a such a row, then TSVAL must be null for it. This is also how it has been implemented in other software applications.
What the FDA wants, is up to the FDA. Don't blame CDISC for it.
According to the FDA Rule v1.3, SD1306 :
Business or Conformance Rule Validated = If the study population is healthy subjects (i.e., healthy subjects flag is Y), this parameter is not expected. If the healthy subject flag is N, then this parameter would contain the diagnosis/medical problem of the study population. [Validation rule; IF healthy volunteers = N then TDIGRP must be present and not null
FDA Validator Rule = When the study population is healthy subjects (TSPARMCD = 'HLTSUBJI' and TSVAL = 'Y'), the Diagnosis Group parameter should be provided with a null Parameter Value (TSVAL should be null when TSPARMCD = 'TDIGRP').
Then according to the Study Data Techinical Conformance Guide, v4.3, Appendix B, for TDIGRP, FDA Notes says this parameter is "Conditional" and the condition is to present this parameter where HLTSUBJI = N.
So, what we do in this case ? This is definitly not clear !
When HLTSUBJI = Y, there are 2 options:
1.to avoid P21 error, TSVAL should be null, so TSVALNF should be populated (=NA). Is that really relevant ?
2.do not present this parameter and add explanation in the reviewer guide.
.... best solutions is that the FDA makes a clear statement of the SD1306 rule and be consistent across its various reference documents (FDA rules, Study Data Conformance Guide) and SDTM-IG too !!