TAETORD labels

k Karen

on August 16, 2014

The TAETORD labels in the SDTM Metadata 3.1.2.csv file (data folder) are generally incorrect. They're correct in the TA domain, but not the other domains. In most other domains, the word Element is plural but should not be. In at least one domain, (EX) the word Planned is missing. Please check - thanks very much.

Forums: SDTM

s Sergiy

on August 18, 2014

Hi Karen, OpenCDISC

Hi Karen,

OpenCDISC validator does not work with Metadata csv files since version 1.4.

We strongly recommend avoiding a usage of outdated versions with no maintenance and support.

Kind Regards,

Sergiy

k Karen

on September 1, 2014

Please check XML for TAETORD labels

Hi Sergiy,

Sorry, I meant the XML file, config-sdtm-3.1.2.xml.

It looks like the SDTMIG for 3.1.2 is not very consistent about the TAETORD label. The labels are different in SE and EX, for example. I'm not suggesting you change those because they're explicitly defined in the IG. But for "model permissible" uses in other domains, I request that OpenCDISC use the label given in the model (not the IG, the model, version 1.4). The model label is "Planned Order of Element within Arm".

Thanks again,

Karen

s Sergiy

on September 3, 2014

Hi Karen, We understand you

Hi Karen,

We understand you concerns and agree with your suggestion. However we cannot change standards.

Unfortunately CDISC never revise and fix already published versions of SDTM.

Each version of SDTM IG is linked to a particular version of SDTM standard. Therefore in SDTM IG 3.1.2, Variable Labels should be taken from SDTM v1.2.

In SDTM IG 3.1.2 a TAERORD "generic" Label is "Planned Order of Elements within Arm".

In SDTM IG v3.2 it's "Planned Order of Element within Arm".

Kind Regards,

Sergiy