SDTM

Description

Technical support questions about SDTM standard and validation rules

November 14, 2008

In checking out openCDISC, I happened across 2 checks firing from our internal checking program, but not from this tool: IR4127: LBORNRHI = 30 and LBORNRLO = 125 IR4134: EXDOSE = 0 and EXDOSU = I believe the above data should fire the noted check. I also note that the Protocol Deviations (DV) dataset doesn't have a definition in the HYBRID config. I assume this is just not yet added at this time. There are others missing as well (PC, PP, some SUPPQUALs, etc). Thanks, Diane

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