| Title | CDISC ODM Specification | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Version | 2.0 | |||||||||
| Prepared by | CDISC Data Exchange Standards Team | |||||||||
| Notes to Readers |
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| Revision History |
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- Introduction (Non-normative)
- Conformity and General Information
- Content of the Standard
- File Conformity
- System Conformity
- ODM Extensions
- Changes from Previous Versions (non-normative)
- Entities and Elements
- Clinical Data Keys
- Study Design and Workflow
- Single Files and Collections
- Transactions
- NullFlavor Information
- Clinical Data Element Ordering
- Element Identifiers and References
- Data Formats
- JSON representation for ODM
- Dataset-JSON
- General Elements
- Specification Structure
- ODM
- Description
- Study
- MetaDataVersion
- Include
- Standards
- AnnotatedCRF
- SupplementalDoc
- ValueListDef
- WhereClauseDef
- Protocol
- WorkflowDef
- StudyEventGroupDef
- StudyEventDef
- ItemGroupDef
- ItemDef
- CodeList
- ConditionDef
- MethodDef
- CommentDef
- Leaf
- MetaDataVersion
- AdminData
- ReferenceData
- ClinicalData
- Association
- Review Period; Licensing Obligations, Representations and Warranties; Limitations of Liability, and Disclaimers
- Appendices