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Development Activities
• Top priority projects:– ODM 1-3-1– SDM – Study Design Model extension– Define.xml
• Other projects:– ISO 21090 Data Type support– Data Clarification Request extension– Null flavors
ODM 1-3-1 Development
• Schema updates completed and being tested• Specification updates nearly complete• Release for review to XML Technologies team in
August• Release to other CDISC teams in September• Want to help us review ODM 1-3-1?
Sample Changes in ODM 1-3-1• Lots of updates and fixes to the specification documentation• Uses same namespace as ODM 1-3-0• Make StudyEventRef, FormRef, ItemGroupRef, and ItemRef non-
mandatory• Add Alias on FormDef, StudyEventDef, CodeList, CodeListItem,
MethodDef, ConditionDef, Protocol, MeasurementUnits• Cleaned up pattern usage in schema• Added incompleteDate and incompleteTime data types• Must use ItemDataAny for Nulls• …
SDM Extension Development
• Draft reviewed at the Intrachange last week• Examples available in draft package• Will be based on ODM 1-3-1• Hope to release for review by end of year• Want to help us review SDM?
SDM in ODM
Define.xml Development
• New features discussed at Intrachange last week• Will likely be based on ODM 1-3-1• ISD / Pilot II using portions of new schema– Feedback from pilot 1– Consistent with developments for pilot 2– Updated style sheet
• Update documentation and examples– Clarify and expand current specification– Got good examples?
Define.xml
• SDTM 3.1.2 support• End of year release for review of updated
define.xml• End of year release planned for a draft
extension to provide ADaM support• Follow-up releases will address additional
metadata needs for SDTM 3.1.2• Want to help us review Define.xml?
ISO 21090 Data Type Extension
• Met with NCI at the Feb 2009 Intrachange• Necessary for HL7 & CDA support– ISO-21090 types are object types• XML-Schema: complexType• Not typical data types like integer or datetime
• Agreed to work on an extension to support the ISO 21090 data types
• Plan to start development of the extension later this year
DCR Extension
• DCR = Data Clarification Request – Data queries
• Needed for unambiguous exchange of clinical data– Eg. to generate Submission-Ready CRFs
• Currently collecting input– http://asserowiki.com/index.php?title=Generating_submission-ready_CRFs_from_ODM_data
• Plan to implement next year• Send ideas or comments if interested
Null Flavors
• The “not done” checkbox on CRFs typically comes under the term “Alternate Response Code” or “Null Flavor”
• The team is discussing how best to represent this in ODM
• This work is in support of the CDASH work• Send ideas or comments if interested
