v2.1.0 Reject Rules

t Takayuki

on February 15, 2016

Hi,

We modified define.xml provided with CDISC Define-XML v2 package and tested it with Define(PMDA) v2.1.0.

In the test, we have found that some Reject rules (DD0002, DD0003, DD0006, DD0020, DD0021, DD0022, DD0025, OD0001, OD0022 and OD0027) were not detected. For example, DD0003 is not detected if ODMVersion, which is one of the Required Attributes, is deleted.

Can you confirm that this is a bug?

Thanks,

Takayuki

Forums: Define.xml

k Kunihito

on February 23, 2016

RE: V2.1.0 REJECT RULES

Dear Takayuki-san,

I am having a difficulty to reproduce the DD0003 issue since the missing ODMVersion attribute (as you suggested) is detected by the tool when I ran. Could you elaborate a little bit more on this issue?

Please also let me know whether the following issue is also happening when you see this issue.

http://www.opencdisc.org/forum/invalid-root-element

For example, the DD0003 will be properly reported when you use the sample Define-XML (for SDTM) that comes with Define-XML V2.0.0 specification, after removing comments before the root ODM element.

Thank you and best regards,

-Ebi

j Jozef

on February 23, 2016

define.xml reject rules

Dear Ebi,

"after removing comments before the root element"

That makes me curious. If you leave these comments in place or replace them by other comments, what is happening then when you validate? Essentially, there should be no difference (with our without comments at the beginning).

l Lex

on February 23, 2016

Root element

It's a bug:

http://www.opencdisc.org/forum/invalid-root-element

The validator did not take into account that there might be a comment node before the ODM element.

k Kunihito

on February 24, 2016

RE: Root Element

Hi Jozef, Lex,

As I referenced in may post, I know the root element issue has already been concluded. The focus of my post is DD0003, which should be distinguished from the root element issue.

j Jozef

on February 24, 2016

DD0003

Dear Ebi, I do not know what XML parser is used, but if it cannot correctly recognize the root element, it can of course also not recognize the "ODMVersion" attribute, as the latter is an attribute of the root element. So, both are probably highly connected (if you can't enter into a house, you cannot inspect what is in the refrigerator that is in the kitchen of that house isn't it?).