DD0039 Variable is in wrong order within Dataset 'EG'.

k Kunihito

on December 12, 2015

I got the DD0039 error when validating my define.xml 2.0 and noticed that the SDTM 3.2 config file has a different order from the SDTMIG 3.2 for EGLEAD and EGMETHOD.

EGLEAD is listed before EGMETHOD in the SDTMIG 3.2 while EGMETHOD comes earlier in the config file.

I am wondering if this is fixed in the next version.

Thank you.

-Ebi

Forums: Define.xml

m Michael

on December 14, 2015

SDTM 3.2 EGLEAD has repalced EGLOC

That's correct. The SDTM 1.4 lists the order for all general FINDINGS as this order

--LOC

--LAT

--DIR

--PORTOT

--METHOD

--RUNID

--ANMETH

--LEAD

However, for SDTM 3.2, they did update EG and replaced EGLOC with EGLEAD variable and maintained the order from 3.1.3. So i agree the order for the IG has always been the following.

EGLOC/EGLEAD
EGMETHOD

We will fix the config and publish the update in next release coming before christmas.

m Max

on December 23, 2015

P21

IG is wrong

Hi Ebi,

In this case the IG is wrong. Whoever updated the document to replace EGLOC with EGLEAD forgot to reorder the variables. As you can see they also forgot to update the Controlled Terms column. It says that EGLEAD is controlled by (LOC), which is clearly wrong.

We will continue following SDTM 1.4 ordering and will not be making any changes at this time.

Thanks,
Max