s S


Dear All,

I have some queries on the validation rule and they are mentioned below can you please look into it and provide your response.

1.If DSDY variable is added into SDTM.DS domain then OpenCDISC gives below warning. 

Domain Values OpenCDISC ID  Publisher ID Message                     

DS         DSDY SD1076          FDAC031        Model permissible variable added into standard domain

2.If DSDY is dropped then OpenCDISC gives below warning. 

Source OpenCDISC ID  Publisher ID Message

DS          SD1083          FDAC124        Missing DSDY variable, when DSDTC variable is  present

Even it is dropped or added it will throw an Warning which one need to be followed and as per SDTM IG DSDY variable is not available.

For example I have explained about DS datasets this issue applies for some other dataset also.

3.Below Error is related to value of variable SDTM.TS.TSVALCD.TRT 

What if TRT information is not yet registed with FDA Substance Registration System (SRS) due to preliminary development stage.

OpenCDISC ID Publisher ID

SD2260        FDAC277

SD2261        FDAC278

SD2262        FDAC279

Thanks in Advance,

Forums: Validation Rule Suggestions

s swathi
on September 20, 2016

Does Pinnacle 21 Community/Enterprise check for SDTM dataset labels? Dataset labels were not checked by versions of OpenCDISC. Just wondering if the dataset label check is added now. Thanks for your time.

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