Inconsistencies in the Define.xml and other General Questions

d Daniel

on February 26, 2010

Hey Guys,

ValueListOID or def:ValueListOID

So on page 13 of the CRT Data Definition Spec it says that def:ValueListOID is a field within def:ValueListRef. I've noticed too that in actual practice, though, it is generally written as ValueListOID (no def:). Do you know which is correct?

Role in Value Level Metadata ItemDef?

It looks like there is no place for Role in the ItemDefs for value level metadata, but when you render the define using the cdisc supplied files (xsl, css etc) there is a column for Role in the value level metadata tables. So which is it? If I leave it out the rendered define.xml looks funny, if I leave it in you throw out an error. Right now I have them both in there! I thought this would please everyone. (Note: WebSDM does not throw out this error)

WebSDM required variables

WebSDM requires a value of KeySequence to be entered but this comes up as an invalid value when run through your validator. This is more of an FYI for users that load into WebSDM and for users who want the FDA to be able to load their defines into WebSDM.

No stylesheet?

I noticed you guys don't ship a stylesheet with your define. Any reason behind this? You could just link to the ugly CDISC one ....but I bet you could come up with a much better looking one if you put a little effort into it.

Sorry , this question is a little support, a little discussion and a little product suggestion....hope you can handle it.

Dan

Forums: Define.xml

t Tim

on February 26, 2010

RE:Inconsistencies in the Define.xml and other General Questions

Hi Dan,

it is generally written as ValueListOID (no def:). Do you know which is correct?

On the basis of the define.xml schema, ValueListOID is an unqualified attribute. Consequently, it must not be written as def:ValueListOID (writing it this way should generate an error if a define.xml document is validated against the define.xml schema). I'm not sure why it's specified as def:ValueListOID in the CRT DD Specification, but it may have been to emphasize that the attribute comes from define.xml and not ODM. It's used in the XML examples in that document as well, but from looking at the actual technical files associated with the specification, this is not permitted (programs that parse these files might accept doing so anyway as a side effect of the technical aspects of parsing XML, but it shouldn't be expected behaviour).

It looks like there is no place for Role in the ItemDefs for value level metadata

I'm unfortunately not 100% clear on where you're referring to here, due to the ambiguity of Role in the ODM specification. All occurances of Role as a separate tag and as an attribute (field) are deprecated in ODM 1.2 and onward, except on the ItemRef element, so it should not appear anywhere else. I'm not sure what the files provided by CDISC are using to render that column, but I'll take a look this evening and get back to you. I suspect that they may have room for backwards compatibility with older documents, or something of that nature.

WebSDM requires a value of KeySequence

KeySequence should be considered an acceptable field on ItemRef. If the Validator has trouble with this, let us know, as I don't believe that should generate any messages.

No stylesheet?

I believe that the config/resources/xsl/config.xsl file that comes with the Validator bundle can be used with define.xml documents as well as our configuration files, but admittedly I don't know how well it will work, since I'm not involved with maintaining those files. I'll make a point to bring it up though, so that we can consider it for the future. Thanks for the suggestion!

Hopefully that covers most of what you were asking, sorry if I misunderstood anything.

Regards,

Tim

d Daniel

on March 1, 2010

RE:Inconsistencies in the Define and Other General Questions

Hi Tim,

Thanks for the great responses. The validator is throwing out errors for KeySequence. Like:

Dan

t Tim

on March 3, 2010

RE:Inconsistencies in the Define.xml and other General Questions

To follow up on my reply, in regards to the issue about KeySequence, the error thrown is "ODM attribute should not be included in Define.xml", which occurs because KeySequence is not mentioned as being a permissible attribute in the define.xml specification (only in the ODM specification). Since the Validator uses this specification to establish the framework for the rules, this is currently the expected behaviour, on that basis.

In relation to the comment about Role as part of Value Level Metadata, I have a personal suggestion on how the situation might be resolved, but it's in no way an authoritive answer to this question:

The <def:ValueListDef> element contains <ItemRef> elements, which, per the ODM 1.2 Specification, may contain the Role attribute. Then, modifying part of line 336 in the define.xml stylesheet to read <xsl:value-of select="@Role"/> instead of <xsl:value-of select="$valueDef/@Role"/> would correctly show the Roles specified on the ItemRef elements for that ValueListDef.