Define.xml

Hi all,

Our team recently started evaluating our Define v2.1 files for SEND 3.1 datasets and after reviewing the Pinnacle 21 validation reports, I identified a few potential checks that may be incorrect:

• DD0004 - "Attribute 'def:HasNoData' is not allowed to appear in element 'ItemRef'":  This is being triggered when def:HasNoData is applied at the value level for blank results, which is acceptable per Define XML 2.1 spec.  Adding comments to the value level ItemDef did not resolve the validation issue.

Hi,

I'm writing to ask some clarification about source for define v2.1 when type is Collected.

We have some data (in this case protocol deviations) collected outside the CRF, but it is not collected by a vendor so we were trying to use source=Subject. In this case when we generate define.xml we automatically get the link to the CRF with the error "Missing Pages value", but data is not collected from CRF so we can't really insert a page linking to the CRF here.

In P21 generated spec, I would like to give comments for assigned variables DICTNAME and DICTVER in SUPPAE, but the assigned value will appear twice in define.xml, how should I fix this situation? And is there another way to put assigned value for variable?

Hello,

While validating define xml 2.1 with Engine FDA (2204.1)/SDTMIG3.3, I have the ‘DD0138-Referenced Standard is missing’ error.

I have this error for the 2 standards other than SDTMIG3.3 (ie SDTMIG 3.4, SDTMIG-MD 1.1 are used for some datasets).

Hi,

1, At the Standards Area(or block): the block of type=CT was tested by imputing like figure1(F1.png) to achieve, i don't is this the correct way. my questions are: a prefix string "CDISC/NCI" seems added to the entry word, if i delete the "CDISC/NCI" from entry, the Standard order goes wrong(CT display before IG); also i don't know how to achieve the Documentation column's entry in spec, when i entry at Codelists sheet - Comment column(and Comment sheet to describe), the entried Description text goes to CodeLists Area of the Define-XML...

1. "Analysis Parameter(s)", "Analysis Variable(s)", "Data References (incl. Selection Criteria)" were blank in ARM.

So, data was input to add, the same error as the capture was generated. Please check which one is the problem.

2.  I download  blank template EXCEL SPEC.

There is "Analysis Criteria"  sheet in EXCEL SPEC.

Please give me example "Analysis Criteria"  sheet.

Hi! 

I have a where clause statement AWRANGE EQ 'Weeks 19-24'. However, when generating the define.xml from P21 Community, it converts the content of VALUE column to upper case letters (WEEKS 19-24) and when validating the define.xml together with the xpt datasets, it can't find any values with that kind of where statement (as the value available in data is 'Weeks 19-24' instead of 'WEEKS 19-24'). 

Below is a snap shot of excel spec from where the P21 generates the define.xml. 

How can I select define version (2.0 or 2.1) when generating define.xml using command line interface?

Find the solution in the forum, there's a new parameter --source.define.standard

Hello.

I am wondering how to write on length/significant digit in "ValueLevel" sheet. (for TYPE=float)

I have a ADaM dataset, and it has a variable which type is float.

For example, the value=1.03 then maximum number of integer is 1, and maximum number of decimal digits is 2.

Therefore, length=3 (1+2) and significant digit = 2.

However, the validation reports for ADaM (based on ADaMIGv1.1) find it has longer than defined max length.

If I store category data (e.g. pH=3.5,. .6.5) described as numeric values into LBORRES in SEND dataset, should the DataType of Value Level of the LBORRES be "float"? Or should the DataType be "text"?