Rule SD0063 issue

b Barry

on December 4, 2014

In the OpenCDISC Validator (v1.5) 3.1.3 configuration file, all “xxETORD” variable labels are “Planned Order of Element within Arm” except for TA.TAETORD. The label for TA.TAETORD is “Order of Element within Arm”. It’s missing the word “Planned” at the beginning of the label. I believe this is causing the output report to generate erroneous SD0063 messages for TA.TAETORD. What do you think?

Forums: SDTM

s Sergiy

on December 10, 2014

Hi Barry, We are aware of

Hi Barry,

No changes are expected.

We are aware of this inconsistency in CDISC standards.

1. SDTM Model has "generic" label "Planned Order of Element within Arm".
2. STDM IG has the same "Planned Order of Element within Arm" label for TAETORD in SE and EX domains.
3. However SDTM IG specifies a label for TAETORD in TA domain as "Order of Element within Arm".

We follow CDISC specifications as it until it's

1. Clear Typo
2. Invalid metadata which does not fit SDTM model. (like Variable Label value > 40 Chars long)

This case does not fit into any of two categories above. Therefore a label for TA.TAETORD is still "Order of Element within Arm" as specified in SDTM IG v3.1.3.

Thanks,

Sergiy