SDTM

Hi, I am validating domains along side the define.xml. In the define.xml, I added a term to the CMROUTE controlled terminology list since it is extensible. I added the term "OTHER" and included it in the define.xml but when I run the validator with both the domains and define.xml I still get CT0031 that states "Route of Administration (--ROUTE) variables values should be populated with terms found in 'Route of Administration' (C66729) CDISC controlled terminology codelist. New terms can be added as long as they are not duplicates, synonyms or subsets of existing standard terms.".

The TAETORD labels in the SDTM Metadata 3.1.2.csv file (data folder) are generally incorrect. They're correct in the TA domain, but not the other domains. In most other domains, the word Element is plural but should not be. In at least one domain, (EX) the word Planned is missing. Please check - thanks very much.

v1.5 of OpenCDISC is generating a CT0086 error message for the PC domain variable PCORRESU. It appears to me that it's using the wrong code terminology to check the variable PCORRESU.  Instead of using the UNIT code terminology to check, the error message indicates that OpenCDISC is using the PKUNIT code terminology.  Same applies to PCSTRESU and error message CT0087.

Dear Open CDISC:My plan is to use AP domains back-leveled to abide by SDTM 3.1.3 data structure conventions. This means that APAE would look like AE with all the "newer variables" introduced by CDISC in SDTM 3.2 defined as suppquals.What class do I use. I tried using the EVents class but the OpenCDISC Validator does not recognize the four characater domain code. ThanksJoyce

using opencdisc 1.5 and config-sdtm-3.1.2.xml I get errors for tumor domains TU, TR, RS saying --EVALID, --ACPTFL are not in the SDTM standard.

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Dear OpenCDISC team:

I just ran into this problem with MI (Microscopic) domain.  I had some Immunohistchemistry data which reports a stain intensity score. It has no units.  Error message indicates the expectation of units.  Please refer to page 4 and 5 MI Section 6.3 for examples in SDTM IG 3.2. 

Dwar All: I am getting the following error message. Validation for the IE domain never completes. It never presents the Domain Error Report. To help us debug this exception, please provide the data below --------- System Information --------- Version: 1.5 JRE: 1.7.0_60 OS: Windows 7 6.1 x86 -------------------------------------- org.opencdisc.validator.data.InvalidDataException: The variable must only appear once at org.opencdisc.validator.data.AbstractDataSource.getVariables(AbstractDataSource.java:112)

We have recently been getting warnings when running OpenCDISC validator for Rule ID SD1118, with a message ‘Neither DSSTDTC nor DSSTDY are populated’. The warnings are occurring on data entered into a form in our eCRF library. The form is designed in such a way that a date is only completed under certain circumstances and dependant on replies to other questions on the form. Our internal groups have confirmed a date being recorded on the current form for every subject would not be required for any of our analysis or reporting.

The Open CDISC 1.5 configuration file does not contain AP domain structures. Should we modify the configuration file to add AP structures as a custom domain? Thanks,Joyce