Jira
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- The ODM file must be a well-formed XML file. See the XML standard for details.
- The ODM file must conform to the XML Namespace standard. See the XML Namespace standard for details.
- The ODM file must contain only elements and attributes defined in the ODM standard schema or in a valid vendor extension schema, and must satisfy the rules about element nesting and the formats of attribute values and element bodies.
- The ODM file must contain a single (top-level) ODM element
- The ODM file must use the ODM v2.0 namespace, which is "http://www.cdisc.org/ns/odm/v2.0"
- The ODMVersion attribute on the top-level ODM element must be set to "2.0"
- The ODM file should begin with a prolog, or XML declaration, as this is considered a best practice
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The XML schema for Version 2.0 of the ODM can be found at https://github.com/cdisc-org/DataExchange-ODM. The final version of this specification will be posted at https://www.cdisc.org/standards/data-exchange/odm.
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<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v2.0"
xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
ODMVersion="2.0"
FileOID="000-00-0000"
FileType="Transactional"
Description="Sample ItemData Extension"
AsOfDateTime="2022-06-04T07:57:00"
CreationDateTime="2022-06-06T10:30:00"> |
The semantic constraints are expressed throughout the rest of this document.
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- The ODM file must be a well-formed JSON file. See the ECMA-404 standard for details.
- The ODM file must satisfy the rules about element nesting and the formats of values defined in the ODM standard.
- The root object corresponds to the ODM element.
- The ODMVersion attribute of the root object must be set to "2.0".
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Info | |||||
| prolog
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{
" clinicalDataODM": { "studyOID ODMVersion": "cdisc 2.com/CDISCPILOT01 0", "metaDataVersionOID FileOID": "MDV.MSGv2.0.SDTMIG.3.3.SDTM.1.7 000-00-0000", "itemGroupData FileType":{ "Transactional","IG.DM "Description":{ "Sample ItemData Extension", " recordsAsOfDateTime":18 "2022-06-04T07:57:00", "CreationDateTime": "2022-06-06T10:30:00", "name Study":"DM", { " labelOID": "Demographics xxx", " itemsStudyName":[ ... "NIH Chronic Low Back Pain example",], "MetaDataVersion": { "itemData OID":[ ... "yyy",] ... } } } } |
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