SAS, XML, and CDISC. Anthony T Friebel XML Development Manager, SAS XML Libname Engine Architect SAS Institute Inc.

SAS, XML, and CDISC Anthony T Friebel XML Development Manager, SAS XML Libname Engine Architect SAS Institute Inc. 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

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 Global/Transfer Metadata Secondary Metadata ODM Study Global Variables Basic Definitions Metadata Version Protocol FormDef Archive Layout Presentation Data Level Study-specific Metadata Administration Level Item GroupDef ItemRef ItemDef User Location Signature Def CLI Q EQ RangeCheck Role ERR MUR Study Data AE ConMed Demog Drug_TRT Pharm01 PhyEx ReferenceData Audit AE ConMed Demog Drug_TRT Pharm01 PhyEx ClinicalData

ODM Data Silos Global/Transfer Metadata Secondary Metadata ODM Study Global Variables Basic Definitions Metadata Version Protocol FormDef Archive Layout Presentation Study Level Study-specific Metadata Administration Level Item GroupDef ItemRef ItemDef User Location Signature Def CLI Q EQ RangeCheck Role ERR MUR Study Data AE ConMed Demog Drug_TRT Pharm01 PhyEx ReferenceData Audit AE ConMed Demog Drug_TRT Pharm01 PhyEx ClinicalData

ODM Data Silos Global/Transfer Metadata Secondary Metadata ODM Study Global Variables Basic Definitions Metadata Version Protocol FormDef Archive Layout Presentation Data Level Study-specific Metadata Administration Level Item GroupRef GroupDef ItemRef ItemDef User Location Signature Def CLI Q EQ RangeCheck Role ERR MUR Study Data AE ConMed Demog Drug_TRT Pharm01 PhyEx ReferenceData Audit AE ConMed Demog Drug_TRT Pharm01 PhyEx ClinicalData

Data Content AE ConMed Demog Drug_TRT Pharm01 PhyEx A/P A/R G/L POS INV

Operational Data Model Location LocationOID StudyOID MetaDataOID FileOID FormRef FormOID StudyEventOID MetaDataOID StudyOID FileOID ItemGroupRef ItemGroupOID FormOID MetaDataOID StudyOID FileOID Protocol StudyEventOID MetaDataOID StudyOID FileOID ODM GlobalVariables FileOID FileOID User UserOID LocationOID FileOID SignatureDef SignatureOID FileOID MetaDataVersion MetaDataOID StudyOID FileOID Presentation PresentationOID MetaDataOID StudyOID FileOID Study StudyOID FileOID CodeListItem CodeListOID MetaDataOID StudyOID FileOID ItemDef ItemOID CodeListOID MetaDataOID StudyOID FileOID ItemRef ItemOID ItemGroupOID MetaDataOID StudyOID FileOID BasicDefinitions MeasurementUnitOID

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 ODM v1.2 Demog ConMed

Single File Operation AE ODM v1.2 PROC CDISC

Single File Operation AE ODM v1.2 SXLE

Multiple File Operation AE ODM v1.2 ConMed PROC CDISC

Multiple File Operation AE ConMed SXLE

Version Comparison 8.2 9.1 Single table PROC CDISC XML Libname PROC CDISC Multiple tables PROC CDISC PROC CDISC

Study Metadata Operation User AE Location ConMed Signature Def ODM v1.2 PROC CDISC

Study Metadata Operation User Location Signature Def AE ConMed SXLE

Read ODM v1.2 SAS Dataset PROC CDISC

Read SAS Dataset ODM v1.2 SXLE XML

Write Oracle SQL Server ODM v1.2 SXLE SAS/ACCESS Libname Engine DB2 Teradata SAS PROC CDISC etc.

PROC CDISC Output Syntax

PROC CDISC Input Syntax

SAS XML Libname Engine ODM Syntax

File Format Comparison 18000 16000 14000 12000 File Size (K) 10000 8000 6000 4000 2000 0 SAS Dataset SAS Dataset Compressed SAS Transport SAS Transport Compressed ODM XML ODM XML Compressed AE (37 vars, 6836 obs) Conmed (21 vars, 3237 obs)

File Format Comparison 2000 1500 File Size (K) 1000 500 AE (37 vars, 6836 obs) 0 SAS Dataset SAS Dataset Compressed SAS Transport SAS Transport Compressed ODM XML ODM XML Compressed Conmed (21 vars, 3237 obs)

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