SDTM

When a user runs OpenCDISC Validator on SDTM data is the set of SDTM checks the same set of SDTM checks used when OpenCDISC Validator runs using SDTM data plus the define.xml?  

Is the first option (SDTM only) a subset of the checks of the second option (SDTM + define)?  OR are there differences in the suite of checks that are used by OpenCDISC Validator for these 2 options?  We want to be sure we aren't missing any checks when running option 1 vs option 2.

Hi, In v2.0 is there a way to specify MedDRA dictionary version? I did the MedDRA setup and added different versions but could not find a way to inform validator to use a specific version.

Thanks. 

Could you please update text for the 'Message' column in Issue Summary worksheet of excel report from v2.0. Currently it displays

I am using the config file SDTM 3.1.2 (FDA).xml in the v2.0 validator and have a question about the codelist association for AE.AECONTRT.  My SDTM.AE data has values of 'Y' and 'N' for this variable, and the validator throws errors for the 'N' values.

As you know, FDA Technical Conformance Guide is inconsistent with CDISC SDTMIG regarding populating ARM/ARMCD for screen failures and not assigned.  Of course you know better than anyone else that many OpenCDISC FDA validation rules use logic assuming SDTMIG rules of ARMCD = 'SCRNFAIL' and ARMCD = 'NOTASSGN' are used.  If we follow FDA guidance (ignoring CDISC), various errors will be trig

Which DataType of TAETORD is correct: integer or float? Using OCC 1.5, we should set All TAETORD DataTypes to integer(setting of OCC 2.0)? Reason for this question: TAETORD DataType has difference between Domains, SDTM version, or OCC version. ->difference between Domains: TA.TAETORD:float and FA.TAETORD:integer of SDTM 3.1.2 and OCC 1.5 ->difference between SDTM ver: TA.TAETORD:float(SDTM 3.1.2) and TA.TAETORD:integer(SDTM 3.1.3) of OCC 1.5 ->difference between OCC ver: TA.TAETORD:float(OCC 1.5) and all of TAETORD:integer(OCC 2.0) Best regards.

I was surprised to find, as well in the FDA worksheet as in the OpenCDISC implementation, rules FDAC0154 "Missing value for --ORRESU, when --ORRES is provided" and FDAC0169 "Missing value for --STRESU, when --STRESC is provided".
We all know that there are so many tests that have no unit. A simple example of an ORRESU for which there is no unit are "NEGATIVE" (many tests), or for the test "pH".
So this rule is ... damned wrong" (thanks FDA!). Similar for FDAC0169.

Is Rule FDAC0128 (Missing --STDY variable, when --STDTC variable is present) implemented in OpenCDISC Community 2.0?
I was testing using an MH dataset (the one that came with define.xml 2.0 spec) which has a MHSTDC column, but no MHSTDY column.
In some cases MHSDTC is a partial date, sometimes a full date.
However, I do not see any errors about FDAC0128 in my output.

If we have a define.xml file associated with our data which type of checks will do opencdisc could you please provide me some examples? while validating the SDTM xpt file.

I am getting some warning messages in the Validator 2.0 for DSDECOD values that are not found in the Completion/Reason for Non-Completion codelist.  The controlled terminology for DSDECOD should be based on what the DSCAT value is for each record.  DSDECOD values of "INFORMED CONSENT OBTAINED" and "RANDOMIZED" should be permitted without a warning message when the DSCAT is "PROTOCOL MILESTONE".  You may also need to allow for other values when DSCAT is "OTHER EVENT".