DD0023 Error regarding Annotated CRF.

Hi Ankur,  Could you provide

Hi Ankur, 

Could you provide define.xml text rather than your SAS code?

Best Regards, 

Sergiy

Please see the text:

Hi Sergiy,

Please see the text of the Define.xml. Please see and let me know if this is what you have asked for and provide me with your expert comments.

 

<?xml version='1.0' encoding='ISO-8859-1'?>

<?xml-stylesheet type='text/xsl' href='define1-0-0.xsl'?>

<ODM

xmlns='http://www.cdisc.org/ns/odm/v1.2'

xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'

xmlns:xlink='http://www.w3.org/1999/xlink'

xmlns:def='http://www.cdisc.org/ns/def/v1.0'

xsi:schemaLocation='http://www.cdisc.org/ns/odm/v1.2 define1-0-0.xsd'

FileOID='XXXXXXXXXXXXXXX'

ODMVersion='1.2'

FileType='Snapshot'

CreationDateTime='2012-07-17T16:27:55'>

 <Study OID='XXXXXXXXXXXXXXXXXXXX'>

 

<GlobalVariables>

<StudyName>XXXXXXXXXXX</StudyName>

<StudyDescription>XXXXXXXXXXX Data Definition</StudyDescription>

<ProtocolName>XXXXXXXXXXXXXXX</ProtocolName>

</GlobalVariables>

 <MetaDataVersion OID='CDISC.SDTM.3.1.2'

 

Name='Study XXXXXXXXXXXXX, Data Definitions'

Description='Study XXXXXXXXXXXXX, Data Definitions'

def:DefineVersion='1.0.0'

def:StandardName='CDISC SDTM'

def:StandardVersion='3.1.2'>

<def:AnnotatedCRF>

<def:DocumentRef leafID='blankcrf'/>

</def:AnnotatedCRF>

<def:leaf ID='blankcrf' xlink:href='blankcrf.pdf'>

<def:title>Annotated Case Report Form</def:title>

</def:leaf>

 

Thanks,

Regards

Ankur

 

Do you use a

Do you use a <def:SupplementalDoc> element anywhere in your define.xml file?

Dear Sergiy, Yes I have used

Dear Sergiy,

Yes I have used <def:SupplementalDoc> in my Define.xml document. Please see the define.xml txt as shown below:

 

 <Study OID='xxxxxxxxxxxxxxxx'>

 

<GlobalVariables>

<StudyName>xxxxxxxxxxxxxxxxxxx</StudyName>

<StudyDescription>xxxxxxxxxxxxxxxxx Data Definition</StudyDescription>

<ProtocolName>xxxxxxxxxxxxxxxx</ProtocolName>

</GlobalVariables>

 <MetaDataVersion OID='CDISC.SDTM.3.1.2'

Name='Study xxxxxxxxxxxxxxxxxx, Data Definitions'

Description='Study xxxxxxxxxxxxxxxx, Data Definitions'

def:DefineVersion='1.0.0'

def:StandardName='CDISC SDTM'

def:StandardVersion='3.1.2'>

<def:AnnotatedCRF>

<def:DocumentRef leafID='blankcrf'/>

</def:AnnotatedCRF>

<def:leaf ID='blankcrf' xlink:href='blankcrf.pdf'>

<def:title>Annotated Case Report Form</def:title>

</def:leaf>

<def:SupplementalDoc>

<def:DocumentRef leafID='reviewersguide'/>

</def:SupplementalDoc>

<def:leaf ID='reviewersguide' xlink:href='reviewersguide.pdf'>

<def:title>Supplemental Data Definition Document</def:title>

</def:leaf>

 

 

Regards

Ankur

See define.xm document

See define.xm document (crt_ddspecification1.pdf)  page 44, #5.2.1. Global Element Order.
The “def:SupplementalDoc” element should be between “def:AnnotatedCRF” and “def:leaf” elements. Something like:

 

<Study OID='xxxxxxxxxxxxxxxx'> 

<GlobalVariables> 

<StudyName>xxxxxxxxxxxxxxxxxxx</StudyName> 

<StudyDescription>xxxxxxxxxxxxxxxxx Data Definition</StudyDescription> 

<ProtocolName>xxxxxxxxxxxxxxxx</ProtocolName> 

</GlobalVariables> 

<MetaDataVersion OID='CDISC.SDTM.3.1.2' 

Name='Study xxxxxxxxxxxxxxxxxx, Data Definitions' 

Description='Study xxxxxxxxxxxxxxxx, Data Definitions' 

def:DefineVersion='1.0.0' def:StandardName='CDISC SDTM'

def:StandardVersion='3.1.2'>

<def:AnnotatedCRF>

<def:DocumentRef leafID='blankcrf'/>

</def:AnnotatedCRF>

 

<def:SupplementalDoc>

<def:DocumentRef leafID='reviewersguide'/>

</def:SupplementalDoc>

 

<def:leaf ID='blankcrf' xlink:href='blankcrf.pdf'>

<def:title>Annotated Case Report Form</def:title>

</def:leaf>

<def:leaf ID='reviewersguide'

xlink:href='reviewersguide.pdf'>

<def:title>Supplemental Data Definition Document</def:title>

</def:leaf>

See also an example on page 39.

Best Regards,
Sergiy Sirichenko

Dear Sergiy, Thanks alot for

Dear Sergiy,

Thanks alot for the script. After making changes to the code as suggested the issue is resolved.

Thanks again.

Regards

Ankur