SD1081, SD1082 checks had algorithms to generate issue messages only if length “excess” is bigger than 5 and 20 characters. A new algorithm for SD1082/FDAC036 does not include any “padding” characters. Therefore a bug is hidden anymore. We’ll fix it in the next Auto-Update release soon.
I found out the following error/warning messages, but the values of TSVALCD seem correct (I’m using the SDTM terminology released on 2014-09-26).
Domain|Record|Count|Variables|Values|OpenCDISC ID|Publisher ID|Message|Category|Severity
TS||1|TSPARMCD, TSVALCD|INTTYPE, C1909|CT2004|FDAC343|TSVALCD value not found in ‘Intervention Type’ non-extensible codelist|Terminology|Error
TS||1|TSPARMCD, TSVALCD|SEXPOP, C49636|CT2004|FDAC343|TSVALCD value not found in ‘Sex of Participants’ non-extensible codelist|Terminology|Error
TS||1|TSPARMCD, TSVALCD|STYPE, C98388|CT2004|FDAC343|TSVALCD value not found in ‘Study Type’ non-extensible codelist|Terminology|Error
TS||1|TSPARMCD, TSVALCD|INTMODEL, C82639|CT2005|FDAC344|TSVALCD value not found in ‘Intervention Model’ extensible codelist|Terminology|Warning
TS||2|TSPARMCD, TSVALCD|ROUTE, C38267|CT2005|FDAC344|TSVALCD value not found in ‘Route of Administration’ extensible codelist|Terminology|Warning
TS||1|TSPARMCD, TSVALCD|TCNTRL, C49649|CT2005|FDAC344|TSVALCD value not found in ‘Control Type’ extensible codelist|Terminology|Warning
TS||1|TSPARMCD, TSVALCD|TINDTP, C49656|CT2005|FDAC344|TSVALCD value not found in ‘Trial Indication Type’ extensible codelist|Terminology|Warning
TS||1|TSPARMCD, TSVALCD|TPHASE, C15602|CT2005|FDAC344|TSVALCD value not found in ‘Trial Phase’ extensible codelist|Terminology|Warning
TS||1|TSPARMCD, TSVALCD|TRT, 5YVB0POT2H|CT2005|FDAC344|TSVALCD value not found in ‘Tumor or Lesion Properties Test Name’ extensible codelist|Terminology|Warning
TS||1|TSPARMCD, TSVAL|TRT, CHLOROPROCAINE|CT2005|FDAC344|TSVAL value not found in ‘Tumor or Lesion Properties Test Name’ extensible codelist|Terminology|Warning
TS||1|TSPARMCD, TSVALCD|TTYPE, C49666|CT2005|FDAC344|TSVALCD value not found in ‘Trial Type’ extensible codelist|Terminology|Warning
TS||1|TSPARMCD, TSVALCD|TTYPE, C49667|CT2005|FDAC344|TSVALCD value not found in ‘Trial Type’ extensible codelist|Terminology|Warning
I validated the SDTM domains of a study with OpenCDISC Community Validation and I found out some errors an warnings that in my opinion could be mistakes.
In details:
Rule FDAC036] The error “Variable length is too long for actual data” was raised for the variables VSORRES and VSSTRESC but I have checked the dataset VS and I found out the these columns have length ‘5’, format ‘$5.’, informat ‘$5.’ and that there are two values of length 5 (‘100.0’ and ‘103.0’). The total number of rows of the datasets is 2261 and only 2 rows contain values of length 5.
Can the fact that the two values of length 5 end with ‘.0’ be the reason of this finding?
Rule FDAC344] Several codes inserted into the variable TSVALCD are reported as being missing into the related codelists, but I have checked and it seems that the codes are correct
Attached you can find the report generated by OpenCDISC Community Validation.