According to the IG 3.1.3 (section 7.6) or IG 3.2 (section 7.4), Example 2 shows an example of how to implement the null lfavor in TSVALNF when the value in TSVAL is missing. In this case, TSVCDREF should be assigned to "ISO 21090".
In my SDTM.TS dataset, some records are populated as follow : TSVAL and TSVALCD are null, TSVALNF is filled in with null flavor values (ie NA, UNK) and TSVCDREF = ISO 21090 for TSPARMCD = INDIC, PCLAS, REGID, TINDTP, TRT.
But rule SD2240, indicates "Invalid TSVCDREF value for INDIC", rule SD2242 "Invalid TSVCDREF value for TRT", rule SD2243 "Invalid TSVCDREF value for PCLAS".
I think these rules should be reviewed in order to take in count the case where TSVALNF is populated and TSVCDREF = ISO 21090.
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Hi,
According to the IG 3.1.3 (section 7.6) or IG 3.2 (section 7.4), Example 2 shows an example of how to implement the null lfavor in TSVALNF when the value in TSVAL is missing. In this case, TSVCDREF should be assigned to "ISO 21090".
In my SDTM.TS dataset, some records are populated as follow : TSVAL and TSVALCD are null, TSVALNF is filled in with null flavor values (ie NA, UNK) and TSVCDREF = ISO 21090 for TSPARMCD = INDIC, PCLAS, REGID, TINDTP, TRT.
But rule SD2240, indicates "Invalid TSVCDREF value for INDIC", rule SD2242 "Invalid TSVCDREF value for TRT", rule SD2243 "Invalid TSVCDREF value for PCLAS".
I think these rules should be reviewed in order to take in count the case where TSVALNF is populated and TSVCDREF = ISO 21090.
Thanks in advance for your answer.