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SAS, XML, and CDISCAnthony “T” FriebelXML Development Manager,SAS XML Libname Engine ArchitectSAS Institute Inc.
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“… XML might just be the ‘ASCII text file’ of the new millennium. A universal and accepted way to transfer information between computer applications…”
Paul Kent, Director, SAS Platform R&D
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“The hierarchical vs. relational wars were fought twenty years ago. The [worst] problem with XML [data markup] is the guys that lost are back.”
Anthony Friebel, XML Manager, SAS Platform R&D
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How SAS interoperates with XML
• XML Libname Engine • XML Libname Engine with XMLMap extensions• XML Mapper• Output Delivery System• Web services, Java Applications, etc.
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CDISC Standards
http://www.cdisc.org/standards/index.html
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CDISC Standards
Operational Data Model (ODM)
Submission Data Standard (SDS)
Study Data Tabulation Model (SDTM)
Laboratory Data Model (Lab)
Define.XML (Machine-readable Define.pdf content definition)
Analysis Data Model (ADaM)
Protocol Representation Group (PR)
Standard Exchange of Non-clinical Data (SEND)
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CDISC ODM
Operational Data Model
(Clinical Trials) Data recording / transfer
Closely models current paper forms
Driven by domain experts and technicians
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CDISC ODM
Contains both metadata and (clinical) data
Metadata• Study-related (protocol, forms, users, locations)• Table and Column
Data• NOT confined solely to clinical data
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ODM Data Silos
ODM Study BasicDefinitions
MetadataVersion
GlobalVariables
ArchiveLayoutFormDefProtocol Presen-
tation
Global/Transfer Metadata Secondary Metadata
AE
ItemGroupDef
Study-specific Metadata
Data Level Administration Level
UserItemDefItemRef SignatureDefLocation
CLI Q RangeCheckEQ Role
ERR MUR
Study Data
ConMed Drug_TRT Pharm01Demog PhyEx
AE ConMed Drug_TRT Pharm01Demog PhyEx ClinicalData
ReferenceData
Audit
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ODM Data Silos
ODM Study BasicDefinitions
MetadataVersion
GlobalVariables
ArchiveLayoutFormDefProtocol Presen-
tation
Global/Transfer Metadata Secondary Metadata
AE
ItemGroupDef
Study-specific Metadata
Data Level Administration Level
UserItemDefItemRef SignatureDefLocation
CLI Q RangeCheckEQ Role
ERR MUR
Study Data
ConMed Drug_TRT Pharm01Demog PhyEx
AE ConMed Drug_TRT Pharm01Demog PhyEx ClinicalData
ReferenceData
Audit
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ODM Data Silos
ODM Study BasicDefinitions
MetadataVersion
GlobalVariables
ArchiveLayoutFormDefProtocol Presen-
tation
Global/Transfer Metadata Secondary Metadata
AE
ItemGroupDef
Study-specific Metadata
Study Level Administration Level
UserItemDefItemRef SignatureDefLocation
CLI Q RangeCheckEQ Role
ERR MUR
Study Data
ConMed Drug_TRT Pharm01Demog PhyEx
AE ConMed Drug_TRT Pharm01Demog PhyEx ClinicalData
ReferenceData
Audit
Copyright © 2003, SAS Institute Inc. All rights reserved.
ODM Data Silos
ODM Study BasicDefinitions
MetadataVersion
GlobalVariables
ArchiveLayoutFormDefProtocol Presen-
tation
Global/Transfer Metadata Secondary Metadata
AE
ItemGroupDef
Study-specific Metadata
Data Level Administration Level
UserItemDefItemRef SignatureDefLocation
CLI Q RangeCheckEQ Role
ERR MUR
Study Data
ConMed Drug_TRT Pharm01Demog PhyEx
AE ConMed Drug_TRT Pharm01Demog PhyEx ClinicalData
ReferenceData
Audit
Copyright © 2003, SAS Institute Inc. All rights reserved.
ODM Data Silos
ODM Study BasicDefinitions
MetadataVersion
GlobalVariables
ArchiveLayoutFormDefProtocol Presen-
tation
Global/Transfer Metadata Secondary Metadata
ItemGroupRef
Study-specific Metadata
Data Level Administration Level
UserItemDefItemRef SignatureDefLocation
CLI Q RangeCheckEQ Role
ERR MUR
ItemGroupDef ItemDefItemRef
CLI Q RangeCheckEQ Role
ERR MUR
Study Data
AE ConMed Drug_TRT Pharm01Demog PhyEx
AE ConMed Drug_TRT Pharm01Demog PhyEx ClinicalData
ReferenceData
Audit
Copyright © 2003, SAS Institute Inc. All rights reserved.
ODM Data Silos
ODM Study BasicDefinitions
MetadataVersion
GlobalVariables
ArchiveLayoutFormDefProtocol Presen-
tation
Global/Transfer Metadata Secondary Metadata
AE
ItemGroupRef
Study-specific Metadata
Data Level Administration Level
UserItemDefItemRef SignatureDefLocation
CLI Q RangeCheckEQ Role
ERR MUR
ItemGroupDef ItemDefItemRef
CLI Q RangeCheckEQ Role
ERR MUR
GlobalVariablesODM FormDef
Study Data
ConMed Drug_TRT Pharm01Demog PhyEx
AE ConMed Drug_TRT Pharm01Demog PhyEx ClinicalData
ReferenceData
Audit
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Data Content
AE ConMed Demog Drug_TRT Pharm01 PhyEx
A/P A/R G/L POS INV
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Operational Data Model
ItemDefItemOIDCodeListOIDMetaDataOIDStudyOIDFileOID
SignatureDefSignatureOIDFileOID
LocationLocationOIDStudyOIDMetaDataOIDFileOID
UserUserOIDLocationOIDFileOID
PresentationPresentationOIDMetaDataOIDStudyOIDFileOID
CodeListItem
CodeListOIDMetaDataOIDStudyOIDFileOID
ItemRefItemOIDItemGroupOIDMetaDataOIDStudyOIDFileOID
ItemGroupRefItemGroupOIDFormOIDMetaDataOIDStudyOIDFileOID
ProtocolStudyEventOIDMetaDataOIDStudyOIDFileOID
FormRefFormOIDStudyEventOIDMetaDataOIDStudyOIDFileOID
MetaDataVersionMetaDataOIDStudyOIDFileOID
BasicDefinitionsMeasurementUnitOID
GlobalVariablesFileOID
StudyStudyOIDFileOID
ODMFileOID
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CDISC ODM
SAS Support• XML Engine native mode (SAS 9)• XML Engine and XMLMap• SAS CDISC ODM Viewer• PROC CDISC
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Single or Multiple Data Content in ODM
AE
ODMv1.2 Demog
ConMed
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Single File Operation
PROC CDISC
AEODMv1.2
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Single File Operation
AEODMv1.2
SXLE
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Multiple File Operation
AE
PROC CDISC
ODMv1.2
ConMed
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Multiple File Operation
SXLE
AE
ConMed
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Version Comparison
Single table
Multiple tables
PROC CDISC
8.2 9.1
XML Libname
PROC CDISC PROC CDISC
PROC CDISC
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Study Metadata Operation
PROC CDISC
ODMv1.2
User SignatureDefLocation
AE ConMed
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Study Metadata Operation
SXLE
User SignatureDefLocation
AE ConMed
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Read
PROC CDISC
SASDataset
ODMv1.2
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ReadSAS
Dataset
SXLE
ODMv1.2
XML
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Oracle
SQL Server
DB2
Teradata
SAS
etc.
Write
SXLESAS/ACCESSODM
v1.2
PROC CDISC
Libname Engine
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PROC CDISC Output Syntax
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PROC CDISC Output Syntax
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PROC CDISC Input Syntax
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PROC CDISC Input Syntax
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SAS XML Libname Engine ODM Syntax
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AE (37 vars, 6836 obs)
Conmed (21 vars, 3237 obs)
SAS Dataset SAS DatasetCompressed
SASTransport
SASTransport
Compressed
ODM XML ODM XMLCompressed
0
2000
4000
6000
8000
10000
12000
14000
16000
18000
File Size (K)
File Format Comparison
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AE (37 vars, 6836 obs)
Conmed (21 vars, 3237 obs)
SAS Dataset SAS DatasetCompressed
SAS Transport SAS TransportCompressed
ODM XML ODM XMLCompressed
0
500
1000
1500
2000
File Size (K)
File Format Comparison
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Useful links for the SAS XML Integration Team
Mailing List :[email protected]
Development Web Pages :http://www.sas.com/rnd/base/index-xml-resources.html
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Thank you
Copyright © 2003, SAS Institute Inc. All rights reserved.Copyright © 2004, SAS Institute Inc. All rights reserved. 39