1777 Sentry Parkway West
Building 17, Suite 405
Blue Bell, PA 19422
+1 (888) 507-2270
Validation Rules
Forums: Validation Rule Suggestions
s
swathi
on September 20, 2016
Validation of SDTM dataset labels
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.
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,