DD0055 invalid class value in Community 2.1

Hi, per Define XML

Hi, per Define XML specification allowable values for this attribute are limited by C103329 codelist. "FINDINGS ABOUT" is not in that codelist at the moment. As per SDTMIG: "Findings About Events or Interventions is a specialization of the Findings General Observation Class", so I think you can use FINDINGS in this case.

Thanks Dmitry. Do you know if

Thanks Dmitry. Do you know if there is still a plan to add FINDINGS ABOUT to the controlled terminology? In the define 2.0 specification it sounded like it would be added, but that was in 2013. 

Class

Hi Cathy,

Good point. I can bring this up in the next CDISC Define-XML development meeting.

Lex

Class

I think that as a development team (in this case Define-XML) we can learn from this. I think that in the specification we should say that the by CDISC-NCI published controlled terminology is "leading" and can change or be extended over time. I just checked the latest version for this codelist, and found that e.g. the term "OCCURRENCE DATA STRUCTURE" is not listed in the define-XML specification either, probably because it was added to the CDISC-CT for "Class" after the define-XML specification was published.

I hope that we can do this kind of checks using SHARE web services in the future.

Finding About as Observation Class?

Hi everybody,

Currently we have a contradiction: the define-XML specification states that "findings about" is a class, and domains of this class should appear after findings, so FA after VS, for instance. Now if we follow the Controlled Terminology, we assign to FA the class "Findings", since "findings about" does not exist. Now we apply the rule that inside a class, domains are ordered alphabetically, and FA comes before VS: a little mind-boggling, right? What would you do practically:

1) Document def:Class="FINDINGS ABOUT", accept the validation message, and explain it by referring to the define-XML specification;

2) Report FA with def:Class="FINDINGS", and break the rule that FA comes after findings domain;

3) Bit of both: def:Class="FINDINGS", and FA comes after VS (but won't we get a message complaining about alphabetical ordre not being respected?)

Cheers,
Thierry

Findings About class

Hi Thierry,

I would definitely go for option 1: set def:Class="FINDINGS ABOUT" and explain in the reviewers guide.
BTW I think that "FINDINGS ABOUT" is not even mentioned in the define.xml specification (at that time we did not know or were not informed that there would come up new SDTM classes), so you should refer to the latest CDISC controlled terminology where it is present.

Findings About Class

Actually, Jozef, in 3.4.2 of the Define-XML v2 specification we mention: "FINDINGS ABOUT - not yet added to the NCI/CDISC Controlled Terminology as of the time of writing this document". We just dropped the ball by not following up to get "FINDINGS ABOUT" added to the GNRLOBSC (C103329) CodeList.

Findings About Class

Thanks for the correction Lex!

Findings About Class

Thanks for the correction Lex!

Findings About Class

Thanks Jozef & Lex,

I am also in favor of option 1, but wanted to be sure that "findings about" not being in the controlled terminology was just an omission, not the result of a deliberate decision not to consider it as a class. From what Lex said, I understand it is just an omission?

Findings About class

Thierry, we will have a Define-XML Dev meeting tomorrow. I will report back after that.

 

Findings About class

Thanks!

Class Value

We discussed this in Friday's Define-XML Dev meeting and agreed to request to have "FINDINGS ABOUT" to be added to the C103329 CodeList. I added a comment to the current Terminology Call for Public Review Package 25 to have this term added (See: http://portal.cdisc.org/CT/default.aspx). We'll see where it goes from there.

Findings About Class

Thanks Lex!

FINDINGS ABOUT

FINDINGS ABOUT is now a new term for the GNRLOBSC codelist in the public review of Controlled Terminology package 30 (comments due April 21 2017).

See: https://www.cdisc.org/public-review/terminology-call-public-review-package-30