Define.xml

I get the error "Missing Alias" in define.xml for a few ADaM datasets and i do not have any split datasets along with "Domain/SASDatasetName mismatch for split dataset" for the same datasets names:

adcgas

adcgii

adcgis

admasc

My ItemDef:

<ItemDef DataType="text" Length="8" Name="HBA1C Units" OID="IT.HBA1C.UNITS" SASFieldName="HBA1CUNITS">
            <Description>
               <TranslatedText xml:lang="en">Units for LBTESTCD=ALB</TranslatedText>
            </Description>
            <CodeListRef CodeListOID="CL.C71620.LBORRESU.HBA1C.UNIT"/>
</ItemDef>

I'm creating define.xml using pinnacle 21 community edition. I need to generate value level metadata for LBTESTCD="HCG". In SDTM LB dataset, I've 2 records one with LBSPEC="Blood" other with LBSPEC="Serum". I want 2 records in define.xml output - one for LBTESTCD="HCG" and LBSPEC="Blood", other for LBTESTCD="HCG" and LBSPEC="Serum"

To achieve this how should I define whereclause (in valuelevel tab) and how to define it in "Whereclause" tab in specs?

Hi,

I generated a Define.xml using C#. The generated define.xml like as follows.

<?xml version="1.0" encoding="utf-8"?>
<?xml-stylesheet type="text/xsl" href="define2-0-0.xsl"?>

Here in the declaration, encoding value is in lowercase (encoding="utf-8"). While validating the xml file in Pinnacle 21 v3.0, I am getting an error as OD0011 - Invalid XML encoding.

Hi! I am exporting the define.xml file and the file is adding "(AD)" onto the end of the description of some (but not all) datasets. For example, in P21E the Description is "Adverse Events Analysis Data", but in the define.xml it displays as "Adverse Events Analysis Data (AD)". Why is this occurring? Related, when validating the define.xml we get the following issue: "Invalid content was found starting with element 'ItemRef'."

Thanks!

Hi P21 team,

could you please clarify why this ERROR message  named in the subject line has been added as i did not find anything in CDISC Define Specification? 

Thanks,

Vitalij

How to insert the referenced documents like acrf.pdf and csdrg.pdf in the Documents sheet.

I giving the above documents but I am getting the below error in the Pinnacle 3.0.2

Hi,

I'm wondering why the Pinnacle21 Community validator outputs error for the origin type attribute of "Derived", using validation rules of SEND.

(I can eliminate the error by assigning a origin type of "DERIVED".)

"Derived" is in the Define-XML v2.0 specification and "DERIVED" is in the SENDIG v3.0 and v3.1. I think the Define-XML v2.0 specification takes priority than SENDIG since the specification is for the Define.xml, when we create Define.xml. And there is the same answer in the SEND Implementation Forum.

Hi,

The length for a value of 123.5 was assigned as 4 in our define.xml

The SignificantDigits was assigned as 1.

For the above case we get a P21 SD1231 Error as shown below.

Hi,

I've used P21 (3.0.2) to generate a Define.xml based on our specs and immediately after generating it I try to validate it using P21. 

Everything goes well except for this error we have "Cannot find the declaration of element 'ODM' using the namespace(s) found on the element. Confirm that 'ODM' is allowed in the Define.xml Standard and has the correct namespace(s)."

Currently the Define.xml ODM tag has the following declaration: