SDTM

Hi We have few customs findings domains and following variables are flagged as expected in v1.4 using IGv3.1.3:

DTC, STRESN, ORRESU, STRESU.

In some SDTM findings domains like EG these are permissible so in any findings domain they should be permisible as well.

Hi This warning shows up for

1) SE.TAETORD (Label=Planned Order of Element within Arm) Updated label from IG 3.1.3

2) TS.TSVAL1 (Label=Parameter Value) as used by earlier version of opencdisc metadata file

Hi, I am getting this warning for 4 variables (in bold) with v1.4 even though variables are in correct order in TA: Studyid, Domain, Armcd, Arm, Taetord, Etcd, Element, Tabranch, Tatrans, Epoch

Hi!

Why does "PKUNIT" exist in the CT if the SDTMIG only lists "UNIT" as a CT for PCORRESU? Can I manually change it to PKUNIT for the codelist in the define.xml later?

Best regards!

Hi OpenCDISC team,

In OpenCDISC v1.4, there are rules for check variables length, such like SD1080, SD1081 and SD1082.

Hi, is it possible to run OpenCDISC against SUPPxx domains? Currently when I run the validator against a study all SUPPxx domains are flagged as "unprocessed resource". Also, can you explain how/if I can add customised domains to the validation process?

I apologise if these are basic questions but its my first time using OpenCDISC. Thanks for your help.

I have a custom check that matches AE and DS on USUBJID.  I want to check that for a given value of DS.DSDECOD there is a specific value set for AE.AEACN.  However I don't think there are any USUBJID values in common withe these combination but what I get out of the report is all the values in DS that match the criteria in DS, just as if I hadn't put the cross reference lunk to AE.

Is this something openCDISC just can't do, or am I missing something here? I've copied the text of my rule below.  I'm running v1.4 downlaoded today.

I'm running OpenCDISC Validator v1.4, using the 3.1.3 config file, against a SUPPPC XPT data file.  The report generated indicates the error SD0086 "SUPPQUAL duplicate records" in the data.  I've looked at the data and there are no duplicates in the SUPPQUAL data for the variable combination in the report.  I've attached a subset of the data that duplicate this problem and should allow you to see the same.

Hi,

In our sponsor defined domains/sponsor defined added variables we get this error telling that the type does not match between the dataset and the define.xml. As far as we can see it does, but are there something other than just type/length this check does?

KR Marianne Carames

I get this error for duplicate subject, AEDECOD and start date