SD0058 for Events class variables - Amendment 1

j Joan

on May 14, 2012

Please note the Events class has been extended to include --LLT, --LLTCD, --PTCD, --HLT, --HLTCD, --HLGT, --HLGTCD, --BDYCD, --SOC, and --SOCCD. It does not seem as if the extension is limited to AE (see pg. 3 amendment 1 list [vers 1.0 final]). Since MH and CE terms can be MedDRA coded, should SD0058 be updated for Amendment 1? As of now, it triggers a warning for MH and CE for the MedDRA hierarchy terms. Thank you

Joan

Forums: SDTM

s Sergiy

on May 21, 2012

Hi Joan, Yes, you are

Hi Joan,

Yes, you are right. The OpenCDISC Amend 1 specifications should be fixed to include new MedDRA variables to all Events Class domains and not be limited to AE only. Now you expect to receive a warning if you use them in MH or CE, but you will be fine with any custom Events domains.

BTW, MedDRA related checks SD2007-2016 are assigned to all Events domains, but set to be inactive. You can manually turn them on, if needed.

Thank you for reported issue!

Best Regards,

Sergiy Sirichenko

j Joan

on July 24, 2012

Events class - Amendment 1

Hi,

However, I don't see that it has been fixed in implentation in recent validator versions posted to the svn.opencdisc.org updates area. For example 1045 configuration / amendment 1. Warnings still appearing for MH, CE.

Thank you.

- Joan

s Sergiy

on July 25, 2012

Hi Joan, I posted my

Hi Joan,

I posted my personal opinion. The question if MedDRA checks should be included for all Events domain is still under discussion. Therefore it’s not implemented yet.

Best Regards,

Sergiy Sirichenko