1. 7. German CDISC User Group Meeting Define
7. German CDISC User Group Meeting Define.xml Generator ODM Validator (define.xml validation)
2010/03/11
Dimitri Kutsenko
Marianne Neumann

2. Define.xml Generator – Key Features
Full version (entimICE Module):
Repository for metadata, data, code lists…
GUI based support for links and dependencies
All changes versioned and audited
Extraction of page numbers from aCRF
Light version:
SAS Macro (SAS Base only)
Metadata passed via parameters and configuration file
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3. Define.xml Parts Define.xml Domain level metadata Attribute level
Value level
metadata
Controlled terminology
Define.xml
External dictionary references
link
link
Algorithms
Transport files
Annotated CRF
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4. define.xml: Attribute Level Metadata
Structural SDTM metadata with references to terminology, dictionaries…
name
type
length
cdisc_type
cdisc_role, cdisc_core…
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5. define.xml: Domain Level Metadata
Object metadata (properties) on SDTM domain templates
CDISC_class
CDISC_purpose
CDISC_description
CDISC_structure
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6. define.xml: Controlled Terminology
Managed as code lists
Bundled to format catalogs
Referenced in attribute metadata (no formats on datasets)
Found via search path (study level)
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7. define.xml: Value Level Metadata
Managed as datasets (e.g. lb_topic)
Addressed via link to datasets (per domain)
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8. define.xml: Algorithms
Definitions are stored as datasets (e.g. algo)
Addressed via link
Reference in attribute metadata
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9. Extract pages from aCRF
Action looks through comments AND content and writes page numbers into metadata column cdisc_crf_pages
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10. Define.xml Generation Magic Button 
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11. ODM Checker entimICE Tools
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12. ODM Checker - Key Features
Define.xml checks supported as extended ODM format
State-of-the-art “SAS free” technology (Skala/Java)
Validated, stand-alone tool
Configurable parameters in the control file
entimICE module
Seamless integration with other tools/modules
Checks (ca. 400 in total)
Xml Scheme (nodes, attributes..)
Content (references, ids, type/iso…)
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