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False positive errors generated when timing variables added to DM
Forums: Troubleshooting and Problems
Good point, Carol! I
Good point, Carol!
I completely agree with you on this subject. We will add Study Day variables as "Model Permissible", because they are complementary to all new DM domain --DTC variables in SDTM v1.3.
Thank you for this catch!
Sergiy
Hi Carol, After more deep
Hi Carol,
After more deep reading of the SDTM v1.3 document I feel that we need to re-evaluate your proposal and my initial decision on it.
The problem is that according to the SDTM Model all RFSTDTC, RFENDTC, RFENDTC, RFXSTDTC, RFXENDTC, RFICDTC, RFPENDTC, and DTHDTC variables are not Timing, but Qualifier variables. Therefore the statement in CDISC SDTM 1.3 section 2.2.5 about complimentary Study Day variables is not applicable in this case.
Also two dash symbols in SDTM Model variable references mean a name of a domain value only. E.g., DMDTC, DMDY. Additional characters may not be added. Therefore variables like RFXENDY or DTHDY are not covered by the Table 2.2.5.
I agree with you that in some cases those Study Day variables could be very helpful for reviewers. However an inclusion of new variables into SDTM data means a violation of the standard compliance.
We need to address this issue to CDISC and FDA team. Meanwhile we have stopped adding new DY variables in the DM domain.
Kind Regards,
Sergiy Sirichenko
OpenCDISC team
Using OpenCDISC 1.4, config-sdtm-3.1.3, and CDISC CT 2013-04-12, the following error is generated when the following timing variables are added to the SDTM DM domain:
SD0058 Variable appears in dataset, but is not in SDTM standard (variables: RFENDY, RFXSTDY, RFXENDY, RFICDY, RFPENDY, and DTHDY)
CDISC SDTM 1.3 section 2.2.5 states “All timing variables are allowed for both SDTMIG and SENDIG.” Table 2.2.5 in SDTM 1.3 includes the timing variables --DY, --STDY, and --ENDY. Therefore, we interpret these variables as being acceptable to add to any general observation class domains corresponding to the --DTC, --STDTC, and --ENDTC variables within that domain.