Validation Rule Suggestions

Hello,

I'm having the following Warning reported for the CO (Comments) domain, for the variable values: COVAL1, COVAL2, COVAL3:

SE0058 - "Variable appears in dataset but is not in SEND standard" - Only variables listed in SEND should appear in a dataset. New sponsor defined variables must not be added, and existing variables must not be renamed or modified

Hello all,

I'm getting the below Warnings for a SC (Subject Characteristics datasets), but only when SCTESTCD is "ALTID" and SCSTRESC SCORRES are numeric values:

SE0015 - "Missing --STRESN value" - Identify records where --STRESC has numeric value, but --STRESN is null

SD0026 - "Missing units on value" - Original Units (--ORRESU) should not be NULL, when Result or Finding in Original Units (--ORRES) is provided

SD0029 - "Missing units on value" - Standard Units (--STRESU) should not be NULL, when Character Result/Finding in Std Units (--STRESC) is provided

Hello all,

At a validation of a dataset using the latest version of Validator, I get multiple Warnings of the following form: "Non-recommended variable length" for Rules: SD1057, SD1058 and SD1059. 

As an example, Rule SD1058  says that: "The length of Planned Arm Code variable (ARMCD) is expected to be 20".

 Hi ,

When we checked SUPPSV data set with parent domain Sv on OpenCDISC, we come across "Cross referenced error" error for visitnum=0. Is the openCDISC fails to check visitnum=0? because when for just checking purpose we changed visitnum 0 to 1 and again rerun openCDISC and found that error get resolved. Please provide suggestion or discuss it.

Thanks and regards,

Shri

For good or bad, CDISC CT includes a separate Unit codelist for PK units. Unfortunately PKUNIT is not a direct subset of UNIT and there are inconsistencies between the two. For example, in the UNIT codelist, ng/mL should be expressed as the equivalent term ug/L, but in PKUNIT ng/mL is the required expression. This preferred term versus synonym disconnect is why the PK units cannot be absorbed directly into the UNIT CT.

Can OpenCDISC terminology checks be enhanced to take this disparity into account, by checking PC and PP units against PKUNIT rather than UNIT?

Check to verify that QNAM doesnot contain any Reserved words(R, E, P, timimg variables) used in SDTM IG.

We recently found an issue in the dataset where SDTM defined permissible variables were defined as QNAM in Supplemental dataset. Opencdisc didnot find this as an error.

I think there may be a problem with SD0089.

TEENRL and TEDUR are permissible variables. These are not in our dataset but SD0089 is appearing on the report.

David

Hello,

This error is generated when the --STDTC variable has a value and the --ENDTC variable is null.  That seems too restrictive.  In real-world data there will be some unknown, unobtainable dates.

Just discovered OpenCDISC.  Hats off to you.

-- jschulte

SD0065 is firing even though the records in the LB domain have LBSTAT="NOT DONE". I wouln't expect a record in SV in this case. Would it make sense to only have this rule fire when LBSTAT is null?

Hello,

We are using a FAMH domain which is allowed according to SDTM IG 3.1.2 page 195.