SAS, XML, and · PDF fileStudy Data Tabulation Model (SDTM) ... Analysis Data Model (ADaM)...

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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.

“… 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

“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

How SAS interoperates with XML

• XML Libname Engine • XML Libname Engine with XMLMap extensions• XML Mapper• Output Delivery System• Web services, Java Applications, etc.

CDISC Standards

http://www.cdisc.org/standards/index.html

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)

CDISC ODM

Operational Data Model

(Clinical Trials) Data recording / transfer

Closely models current paper forms

Driven by domain experts and technicians

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

ODM Data Silos

ODM Study BasicDefinitions

MetadataVersion

GlobalVariables

ArchiveLayoutFormDefProtocol Presen-

tation

Global/Transfer Metadata Secondary Metadata

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

ODM Data Silos

MetadataVersion

GlobalVariables

tation

ItemGroupDef

ERR MUR

Study Data

ReferenceData

ODM Data Silos

MetadataVersion

GlobalVariables

tation

ItemGroupDef

Study Level Administration Level

ERR MUR

Study Data

ReferenceData

ODM Data Silos

MetadataVersion

GlobalVariables

tation

ItemGroupDef

ERR MUR

Study Data

ReferenceData

ODM Data Silos

MetadataVersion

GlobalVariables

tation

ItemGroupRef

ERR MUR

ItemGroupDef ItemDefItemRef

ERR MUR

Study Data

AE ConMed Drug_TRT Pharm01Demog PhyEx

ReferenceData

ODM Data Silos

MetadataVersion

GlobalVariables

tation

ItemGroupRef

ERR MUR

ItemGroupDef ItemDefItemRef

ERR MUR

GlobalVariablesODM FormDef

Study Data

ReferenceData

Data Content

AE ConMed Demog Drug_TRT Pharm01 PhyEx

A/P A/R G/L POS INV

Operational Data Model

ItemDefItemOIDCodeListOIDMetaDataOIDStudyOIDFileOID

SignatureDefSignatureOIDFileOID

LocationLocationOIDStudyOIDMetaDataOIDFileOID

UserUserOIDLocationOIDFileOID

PresentationPresentationOIDMetaDataOIDStudyOIDFileOID

CodeListItem

CodeListOIDMetaDataOIDStudyOIDFileOID

ItemRefItemOIDItemGroupOIDMetaDataOIDStudyOIDFileOID

ItemGroupRefItemGroupOIDFormOIDMetaDataOIDStudyOIDFileOID

ProtocolStudyEventOIDMetaDataOIDStudyOIDFileOID

FormRefFormOIDStudyEventOIDMetaDataOIDStudyOIDFileOID

MetaDataVersionMetaDataOIDStudyOIDFileOID

BasicDefinitionsMeasurementUnitOID

GlobalVariablesFileOID

StudyStudyOIDFileOID

ODMFileOID

CDISC ODM

SAS Support• XML Engine native mode (SAS 9)• XML Engine and XMLMap• SAS CDISC ODM Viewer• PROC CDISC

Single or Multiple Data Content in ODM

ODMv1.2 Demog

ConMed

Single File Operation

PROC CDISC

AEODMv1.2

Single File Operation

AEODMv1.2

Multiple File Operation

PROC CDISC

ODMv1.2

ConMed

Multiple File Operation

ConMed

Version Comparison

Single table

Multiple tables

PROC CDISC

8.2 9.1

XML Libname

PROC CDISC PROC CDISC

PROC CDISC

Study Metadata Operation

PROC CDISC

ODMv1.2

User SignatureDefLocation

AE ConMed

Study Metadata Operation

User SignatureDefLocation

AE ConMed

PROC CDISC

SASDataset

ODMv1.2

ReadSAS

Dataset

ODMv1.2

Oracle

SQL Server

Teradata

SXLESAS/ACCESSODM

PROC CDISC

Libname Engine

PROC CDISC Output Syntax

PROC CDISC Input Syntax

SAS XML Libname Engine ODM Syntax

AE (37 vars, 6836 obs)

Conmed (21 vars, 3237 obs)

SAS Dataset SAS DatasetCompressed

SASTransport

Compressed

ODM XML ODM XMLCompressed

File Size (K)

File Format Comparison

AE (37 vars, 6836 obs)

Conmed (21 vars, 3237 obs)

SAS Dataset SAS DatasetCompressed

SAS Transport SAS TransportCompressed

ODM XML ODM XMLCompressed

File Size (K)

File Format Comparison

Useful links for the SAS XML Integration Team

Mailing List :XMLEngine@SAS.com

Development Web Pages :http://www.sas.com/rnd/base/index-xml-resources.html

Thank you

SAS, XML, and · PDF fileStudy Data Tabulation Model (SDTM) ... Analysis Data Model (ADaM)...

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