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False positive errors when the value of "MULTIPLE" exists as a value for non-result qualifier variables
Forums: Troubleshooting and Problems
Hi Carol, A purpose of
Hi Carol,
A purpose of CTxxxx checks is to compare data values with the CDISC Terminology standard. If any new value is added, a user/reviewer should be notified.
Formally we may not skip the compliance with CDISC CT by adding new values. Even if those values are present as examples in SDTM IG.
Therefore I do not think that a Warning on the MULTIPLE value is a false-positive error. However I completely agree with you that it's quite confusing, because CDISC team recommended to use the MULTIPLE value in SDTM IG, but did not include it in all relevant CT codelists.
We enforce CDISC standards' compliance, but the CDISC organization is their real owner. Please address this issue to CDISC SDTM and CT teams.
The only exception with CDISC Standards compliance we are doing now is related to a recent change of the CT (RACE) codelist attribute from Extensible to Non-Extensible. It was done in the SDTM Terminology v. 2013-04-12.
I believe that it's clearly an error which should be fixed. Therefore we will keep the (RACE) CT check as an Warning, but not as an Error.
Thank you,
Sergiy
Using OpenCDISC 1.4, config-sdtm-3.1.3, and CDISC CT 2013-04-12, the following CT errors are generated when the value “MULTIPLE” exists as a value for the following non-result qualifier variables:
CT0001 Value for --ACN not found in (ACN) CT codelist (value = “MULTIPLE”)
CT0011 Value for EGMETHOD not found in (EGMETHOD) CT codelist (value = “MULTIPLE”)
CT0019 Value for --DOSFRM not found in (FRM) CT codelist (value = “MULTIPLE”)
CT0027 Value for --OUT not found in (OUT) CT codelist (value = “MULTIPLE”)
CT0029 Value for RACE not found in (RACE) CT codelist (value = “MULTIPLE”)
CT0031 Value for --ROUTE not found in (ROUTE) CT codelist(value = “MULTIPLE”)
Per CDISC SDTMIG 3.1.3 section 4.1.2.8.3, for non-result qualifier variables, "If multiple values exist..., then the value for the Qualifier variable should be "MULTIPLE" and SUPP-- should be used to store the individual responses." When it was suggested to Chris Tolk, CDSIC Controlled Terminology Lead, that “MULTIPLE” be added to the controlled terminology file for all applicable codelists, she said that this should not be necessary because allowing for the value of “MULTIPLE” (e.g., for consistency checks) could be accomplished programmatically.
Could the value of “MULTIPLE” be programmatically allowed by OpenCDISC for the above variables so that these false positive errors would not be generated?