Hi Ankur,
Could you provide define.xml text rather than your SAS code?
Best Regards,
Sergiy
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=‘XLink namespace’
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’>
XXXXXXXXXXX
XXXXXXXXXXX Data Definition
XXXXXXXXXXXXXXX
<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:DocumentRef leafID=‘blankcrf’/>
</def:AnnotatedCRF>
<def:leaf ID=‘blankcrf’ xlink:href=‘blankcrf.pdf’>
def:titleAnnotated Case Report Form</def:title>
</def:leaf>
Thanks,
Regards
Ankur
Do you use a def:SupplementalDoc element anywhere in your define.xml file?
Dear Sergiy,
Yes I have used def:SupplementalDoc in my Define.xml document. Please see the define.xml txt as shown below:
xxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxx Data Definition
xxxxxxxxxxxxxxxx
<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:DocumentRef leafID=‘blankcrf’/>
</def:AnnotatedCRF>
<def:leaf ID=‘blankcrf’ xlink:href=‘blankcrf.pdf’>
def:titleAnnotated Case Report Form</def:title>
</def:leaf>
<def:DocumentRef leafID=‘reviewersguide’/>
</def:SupplementalDoc>
<def:leaf ID=‘reviewersguide’ xlink:href=‘reviewersguide.pdf’>
def:titleSupplemental Data Definition Document</def:title>
</def:leaf>
Regards
Ankur
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 the script. After making changes to the code as suggested the issue is resolved.
Thanks again.
Regards
Ankur
Dear All,
In order to validate Define.xml I have created I ran it through OpenCDISC validator and found this error as shown below regarding Annotated Case Report form:
//MetaDataVersion[@OID=‘CDISC.SDTM.3.1.2’]/def:leaf[1] def:leaf Annotated Case Report Form DD0023 Element ‘def:leaf’ in wrong order within Define.xml Metadata Error
I tried to look for which element is ordered incorrectly but all my efforts went in vain.
Could you please help me and suggest what to update in the code as shown to overcome the issue:
/METADATA VERSION/
PUT “<MetaDataVersion OID=‘CDISC.SDTM.3.1.2’”;
PUT “Name=‘Study " “&STUDYNAME.” ", Data Definitions’”;
PUT “Description=” “‘Study " “&STUDYNAME.” ", Data Definitions’”;
PUT “def:DefineVersion=‘1.0.0’”;
PUT “def:StandardName=‘CDISC SDTM’”;
PUT “def:StandardVersion=‘3.1.2’>”;
PUT “def:AnnotatedCRF”;
PUT “<def:DocumentRef leafID='” “&CRF.” “'/>”;
PUT “</def:AnnotatedCRF>”;
PUT “<def:leaf ID='” “&CRF.” “’ xlink:href='” “&CRF.” “.pdf’>”;
PUT “def:titleAnnotated Case Report Form</def:title>”;
PUT “</def:leaf>”;
Your help is highly appreciated. This is the only error standing between me and finalizing my first Define.xml.
Best Regards,
Ankur