DD0039 Variable in wrong order

[Jozef]

When adding SDTM variables that are not in the SDTMIG table for that domain, one need to follow the order as given in the corresponding SDTM MODEL. So NOT at the end.
For example, for SDTMIG 3.2, the SDTM model is 1.4, for which you can find the documentation at:

SDTM v1.4

I would also encourage you to use the “CDISC Library Browser” for that (free account for CDISC members): CDISC Data Standards Browser.

Modern software such as our SDTM-ETL submission developer inserts such variables at the right position automatically.

With best regards,
Jozef Aerts
XML4Pharma and CDISC Volunteer

[jyothi.atmakuri]

Dear Team!

We are getting DD0039 errors in 2 scenario’s.

#1. EPOCH, was the only timing variable kept in CO, which cannot be dropped due to dependencies in data .

#2. EVAL in AE, differentiates AE reported by Investigator or adj Committee . Else data has duplicate records.

Reason why, we had to keep them in SDTM.

Since these are not SDTM variables as per IG, and also not in configuration file from pinnacle, we kept them at the end.. after all variables.

Using pinnacle 3.0.2, PMDA engine. Define has DD0039.

Can we treat this as False positive? As we kept them at the end after all variables?

Please suggest!

Thank you

Jyothi