False positive errors when --TESTCD equals “<domain prefix>ALL”

Pinnacle 21 Support Troubleshooting and Problems
1

Hi Carol,

I am sorry. It’s a bug in definition of checks. It’s fixed. Please watch for v1.4.1 release soon.

Meanwhile you can fix it yourself. You have to replaced a CTxxxx check definitions in config files by corrected ones. Please contact us if any assitance is needed.

Sorry for inconvinience.

Regards,

Sergiy

<val:Lookup ID=“CT0082” Variable=“VAL:DECODE == LBTESTCD” From=“FILE:CDISC:%System.ConfigDirectory%/data/CDISC/SDTM/%System.CDISC.Version%/SDTM Terminology.txt” Where=“CodelistCode == ‘C67154’ @and CDISCSubmissionValue == [LBTEST]” When=“LBTEST != ‘’ @and LBTESTCD != ‘’” WhereFailure=“Ignore” Message=“LBTEST and LBTESTCD values do not have the same Code in CDISC CT” Description=“Values for Lab Test or Examination Short Name (LBTESTCD) and Lab Test or Examination Name (LBTEST) variables must be populated using terms with the same Code value in CDISC control terminology. There is one-to-one relationship between LBTESTCD and LBTEST values defined in CDISC control terminilogy by Code value.” ActiveUnless=“%Variables[LBTEST].Define.WithCodeList%” Category=“Terminology” Type=“Error”/>

<val:Lookup ID=“CT0083” Variable=“VAL:DECODE == VSTESTCD” From=“FILE:CDISC:%System.ConfigDirectory%/data/CDISC/SDTM/%System.CDISC.Version%/SDTM Terminology.txt” Where=“CodelistCode == ‘C67153’ @and CDISCSubmissionValue == [VSTEST]” When=“VSTEST != ‘’ @and VSTESTCD != ‘’” WhereFailure=“Ignore” Message=“VSTEST and VSTESTCD values do not have the same Code in CDISC CT” Description=“Values for Vital Signs Test Short Name (VSTESTCD) and Vital Signs Test Name (VSTEST) variables must be populated using terms with the same Code value in CDISC control terminology. There is one-to-one relationship between VSTESTCD and VSTEST values defined in CDISC control terminilogy by Code value.” ActiveUnless=“%Variables[VSTEST].Define.WithCodeList%” Category=“Terminology” Type=“Error”/>

<val:Lookup ID=“CT0085” Variable=“VAL:DECODE == EGTESTCD” From=“FILE:CDISC:%System.ConfigDirectory%/data/CDISC/SDTM/%System.CDISC.Version%/SDTM Terminology.txt” Where=“CodelistCode == ‘C71152’ @and CDISCSubmissionValue == [EGTEST]” When=“EGTEST != ‘’ @and EGTESTCD != ‘’” WhereFailure=“Ignore” Message=“EGTEST and EGTESTCD values do not have the same Code in CDISC CT” Description=“Values for ECG Test or Examination Short Name (EGTESTCD) and ECG Test or Examination Name (EGTEST) variables must be populated using terms with the same Code value in CDISC control terminology. There is one-to-one relationship between EGTESTCD and EGTEST values defined in CDISC control terminilogy by Code value.” ActiveUnless=“%Variables[EGTEST].Define.WithCodeList%” Category=“Terminology” Type=“Error”/>

2

Using OpenCDISC 1.4, config-sdtm-3.1.3, and CDISC CT 2013-04-12, the following CT errors are generated when the value “ALL” exist as a value of --TESTCD:

CT0085 EGTEST and EGTESTCD values do not have the same Code in CDISC CT (variables: EGTESTCD, EGTEST; Values: “EGALL”, “ECG Data”)

CT0082 LBTEST and LBTESTCD values do not have the same Code in CDISC CT (variables: LBTESTCD, LBTEST; Values: “LBALL”, “Lab Data”)

CT0083 VSTEST and VSTESTCD values do not have the same Code in CDISC CT (variables: VSTESTCD, VSTEST; Values: “VSALL”, “Vital Signs Data”)

These values are allowable and, in fact, prescribed per SDTMIG 3.1.3 section 4.1.5.1.2 in order to represent that an entire CRF page of tests was not done. Could these --TESTCD values be programmatically allowed by OpenCDISC so that these false positive errors would not be generated?