Page 1
Copyright © 2003, SAS Institute Inc. All rights reserved.SAS is a registered trademark or trademark of SAS Institute Inc. in the USA and other countries. ® indicates USA registration. Other brand and product names are registered trademarks or Trademarks of their respective companies
SAS, XML, and CDISCAnthony “T” FriebelXML Development Manager,SAS XML Libname Engine ArchitectSAS Institute Inc.
Page 2
Copyright © 2003, SAS Institute Inc. All rights reserved.
“… 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
Page 3
Copyright © 2003, SAS Institute Inc. All rights reserved.
“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
Page 4
Copyright © 2003, SAS Institute Inc. All rights reserved.
How SAS interoperates with XML
• XML Libname Engine • XML Libname Engine with XMLMap extensions• XML Mapper• Output Delivery System• Web services, Java Applications, etc.
Page 5
Copyright © 2003, SAS Institute Inc. All rights reserved.
CDISC Standards
http://www.cdisc.org/standards/index.html
Page 6
Copyright © 2003, SAS Institute Inc. All rights reserved.
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)
Page 7
Copyright © 2003, SAS Institute Inc. All rights reserved.
CDISC ODM
Operational Data Model
(Clinical Trials) Data recording / transfer
Closely models current paper forms
Driven by domain experts and technicians
Page 8
Copyright © 2003, SAS Institute Inc. All rights reserved.
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
Page 9
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
Page 10
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
Page 11
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
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
Page 12
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
Page 13
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
Page 14
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
Page 15
Copyright © 2003, SAS Institute Inc. All rights reserved.
Data Content
AE ConMed Demog Drug_TRT Pharm01 PhyEx
A/P A/R G/L POS INV
Page 16
Copyright © 2003, SAS Institute Inc. All rights reserved.
Operational Data Model
ItemDefItemOIDCodeListOIDMetaDataOIDStudyOIDFileOID
SignatureDefSignatureOIDFileOID
LocationLocationOIDStudyOIDMetaDataOIDFileOID
UserUserOIDLocationOIDFileOID
PresentationPresentationOIDMetaDataOIDStudyOIDFileOID
CodeListItem
CodeListOIDMetaDataOIDStudyOIDFileOID
ItemRefItemOIDItemGroupOIDMetaDataOIDStudyOIDFileOID
ItemGroupRefItemGroupOIDFormOIDMetaDataOIDStudyOIDFileOID
ProtocolStudyEventOIDMetaDataOIDStudyOIDFileOID
FormRefFormOIDStudyEventOIDMetaDataOIDStudyOIDFileOID
MetaDataVersionMetaDataOIDStudyOIDFileOID
BasicDefinitionsMeasurementUnitOID
GlobalVariablesFileOID
StudyStudyOIDFileOID
ODMFileOID
Page 17
Copyright © 2003, SAS Institute Inc. All rights reserved.
CDISC ODM
SAS Support• XML Engine native mode (SAS 9)• XML Engine and XMLMap• SAS CDISC ODM Viewer• PROC CDISC
Page 18
Copyright © 2003, SAS Institute Inc. All rights reserved.
Single or Multiple Data Content in ODM
AE
ODMv1.2 Demog
ConMed
Page 19
Copyright © 2003, SAS Institute Inc. All rights reserved.
Single File Operation
PROC CDISC
AEODMv1.2
Page 20
Copyright © 2003, SAS Institute Inc. All rights reserved.
Single File Operation
AEODMv1.2
SXLE
Page 21
Copyright © 2003, SAS Institute Inc. All rights reserved.
Multiple File Operation
AE
PROC CDISC
ODMv1.2
ConMed
Page 22
Copyright © 2003, SAS Institute Inc. All rights reserved.
Multiple File Operation
SXLE
AE
ConMed
Page 23
Copyright © 2003, SAS Institute Inc. All rights reserved.
Version Comparison
Single table
Multiple tables
PROC CDISC
8.2 9.1
XML Libname
PROC CDISC PROC CDISC
PROC CDISC
Page 24
Copyright © 2003, SAS Institute Inc. All rights reserved.
Study Metadata Operation
PROC CDISC
ODMv1.2
User SignatureDefLocation
AE ConMed
Page 25
Copyright © 2003, SAS Institute Inc. All rights reserved.
Study Metadata Operation
SXLE
User SignatureDefLocation
AE ConMed
Page 26
Copyright © 2003, SAS Institute Inc. All rights reserved.
Read
PROC CDISC
SASDataset
ODMv1.2
Page 27
Copyright © 2003, SAS Institute Inc. All rights reserved.
ReadSAS
Dataset
SXLE
ODMv1.2
XML
Page 28
Copyright © 2003, SAS Institute Inc. All rights reserved.
Oracle
SQL Server
DB2
Teradata
SAS
etc.
Write
SXLESAS/ACCESSODM
v1.2
PROC CDISC
Libname Engine
Page 29
Copyright © 2003, SAS Institute Inc. All rights reserved.
PROC CDISC Output Syntax
Page 30
Copyright © 2003, SAS Institute Inc. All rights reserved.
PROC CDISC Output Syntax
Page 31
Copyright © 2003, SAS Institute Inc. All rights reserved.
PROC CDISC Input Syntax
Page 32
Copyright © 2003, SAS Institute Inc. All rights reserved.
PROC CDISC Input Syntax
Page 33
Copyright © 2003, SAS Institute Inc. All rights reserved.
SAS XML Libname Engine ODM Syntax
Page 34
Copyright © 2003, SAS Institute Inc. All rights reserved.
Page 35
Copyright © 2003, SAS Institute Inc. All rights reserved.
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
Page 36
Copyright © 2003, SAS Institute Inc. All rights reserved.
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
Page 37
Copyright © 2003, SAS Institute Inc. All rights reserved.
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
Page 38
Copyright © 2003, SAS Institute Inc. All rights reserved.
Thank you
Page 39
Copyright © 2003, SAS Institute Inc. All rights reserved.Copyright © 2004, SAS Institute Inc. All rights reserved. 39