MHSTDTC missing

j Jozef

on January 28, 2017

In my customer's submission I get a lot of warnings for MH "Missing values for --STDTC, --STRF and --STRTPT, when --ENDTC, --ENRF or --ENRTPT is provided" (FDAC122). The MH dataset in this case has an MHSTDTC column (sometimes with NULL values) but no MHSTRF nor MHSTRTPT column.
Each time MHSTDTC is null, but either MHENDTC or MHENRF is not null, I get this error.
I looked in the SDTM-IG 3.2, and there are examples which exactly matches this situation (examples 1 and 3 on pages 156 and 158), so I wonder whether the rule is more severe than the SDTM-IG.

Many thanks in advance,

Jozef

Forums: SDTM

s Sergiy

on January 30, 2017

Hi Jozef, …

Hi Jozef,

P21 Validator is designed to handle regulatory submissions. Therefore, it is not limited to CDISC standards and include additional review specific checks.

For example, see http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/

Regards,

Sergiy