sas, xml, and · pdf filestudy data tabulation model (sdtm) ... analysis data model (adam)...

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.

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


“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

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


ODM Data Silos


MetadataVersion

GlobalVariables


tation


AE

ItemGroupDef


Study Level Administration Level



ERR MUR

Study Data



ReferenceData

Audit


ODM Data Silos


MetadataVersion

GlobalVariables


tation


AE

ItemGroupDef





ERR MUR

Study Data



ReferenceData

Audit


ODM Data Silos


MetadataVersion

GlobalVariables


tation


ItemGroupRef





ERR MUR

ItemGroupDef ItemDefItemRef


ERR MUR

Study Data

AE ConMed Drug_TRT Pharm01Demog PhyEx


ReferenceData

Audit


ODM Data Silos


MetadataVersion

GlobalVariables


tation


AE

ItemGroupRef





ERR MUR

ItemGroupDef ItemDefItemRef


ERR MUR

GlobalVariablesODM FormDef

Study Data



ReferenceData

Audit


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

AE

ODMv1.2 Demog

ConMed


Single File Operation

PROC CDISC

AEODMv1.2


Single File Operation

AEODMv1.2

SXLE


Multiple File Operation

AE

PROC CDISC

ODMv1.2

ConMed


Multiple File Operation

SXLE

AE

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

SXLE

User SignatureDefLocation

AE ConMed


Read

PROC CDISC

SASDataset

ODMv1.2


ReadSAS

Dataset

SXLE

ODMv1.2

XML


Oracle

SQL Server

DB2

Teradata

SAS

etc.

Write

SXLESAS/ACCESSODM

v1.2

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

SASTransport

Compressed

ODM XML ODM XMLCompressed

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

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

0

500

1000

1500

2000

File Size (K)

File Format Comparison


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


Thank you

sas, xml, and · pdf filestudy data tabulation model (sdtm) ... analysis data model (adam)...

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