CDISC XML Technologies Standards Development An Update Sam Hume

Development Activities Top priority projects: – ODM – SDM – Study Design Model extension – Define.xml Other projects: – ISO Data Type support – Data Clarification Request extension – Null flavors

ODM 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 Lots of updates and fixes to the specification documentation Uses same namespace as ODM 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 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 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 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 Want to help us review Define.xml?

ISO Data Type Extension Met with NCI at the Feb 2009 Intrachange Necessary for HL7 & CDA support – ISO 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 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 – 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

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