Product Highlights of Life Sciences(Proc CDISC & SAS ODM Viewer)
Akihiro Hirata
Professional Service Department
Technical Services Division
SAS Institute Japan Ltd.
Copyright © 2005, SAS Institute Inc. All rights reserved.

CDISC Standards
 Operational Data Model (ODM)
 Study Data Tabulation Model (SDTM)
 Case Report Tabulation Data Definition
Specification (CRTDDS - aka define.xml)

 Laboratory Data Model (Lab) Analysis Data Model (ADaM) Standard Exchange of Non-clinical Data (SEND)

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SAS Involvement
 Ed Helton• Chief Strategist, Regulatory and Biomedical Affairs

 David Handelsman• Solutions Strategist, Clinical R&D

 Eric Brinsfield• Director Consulting Services

 Anthony Friebel• XML Strategist, Platform R&D

Copyright © 2005, SAS Institute Inc. All rights reserved.

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SAS Involvement
 Ed Helton• CDISC Board of Directors

 David Handelsman• Solutions Strategist, Clinical R&D

 Eric Brinsfield• Director Consulting Services

 Anthony Friebel• XML Strategist, Platform R&D

Copyright © 2005, SAS Institute Inc. All rights reserved.

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SAS Involvement
 Ed Helton• CDISC Board of Directors

 David Handelsman• CDISC Industry Advisory Board Eric Brinsfield• Director Consulting Services

 Anthony Friebel• XML Strategist, Platform R&D

Copyright © 2005, SAS Institute Inc. All rights reserved.

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SAS Involvement
 Ed Helton• CDISC Board of Directors

 David Handelsman• CDISC Industry Advisory Board Eric Brinsfield• ADaM Team Anthony Friebel• XML Strategist, Platform R&D

Copyright © 2005, SAS Institute Inc. All rights reserved.

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SAS Involvement
 Ed Helton• CDISC Board of Directors

 David Handelsman• CDISC Industry Advisory Board Eric Brinsfield• ADaM Team Anthony Friebel• ODM Team• define.xml Team (principal contributor)• ODM/HL7 Harmonization Team

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SAS Position
 Project customer investment in legacy systems
 Provide path for new technology migration
 Activity support and participate in standards
processes and organization (like CDISC)

 Continue to evolve built-in product support

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SAS CDISC Support
 XML Engine ODM native mode (SAS 9)
 XML Engine and XMLMap Extensions
 PROC CDISC(ODM,SDTM)
 New base SAS formats/informats for ISO-8601(ex.2005-12-15T13:14:17)

 SAS CDISC ODM Viewer (Now only in English )Module is available(free download).
This Viewer is a beta copy, for evaluation process.

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SAS XML Libname Engine ODM Syntax

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PROC CDISC Input Syntax

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PROC CDISC Output Syntax

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PROC CDISC ODM read/write capability (Production)
 SDTM content validation (Production)
 CRT-DDS - aka define.xml (Coming soon)
 Lab,SEND,ADaM (Planning stage)

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PROC CDISC – SDTM Syntax
PROC CDISC
SDTM

MODEL=SDTM ;SDTMVersion=“3.1” ;DOMAINDATA DATA=results.AE
DOMAIN=AE
CATEGORY=EVENTS ;RUN ;Copyright © 2005, SAS Institute Inc. All rights reserved.

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CDISC SDTM – Supported Domains

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CDISC SDTM Validation – Metadata Level
 Verifies that all required variables are present inthe data set

 Reports as an error any variables in the data set
that are not defined in the domain

 Reports a warning for any expected domain
variables that are not in the data set

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CDISC SDTM Validation – Metadata Level Notes any permitted domain variables that arenot in the data set

 Verifies that all domain variables are of theexpected data type and proper length Detects any domain variables that are assigned
a controlled terminology specification by thedomain and do not have a format assigned tothem Reports as an error any variables in thedata set that are not defined in the domain

Copyright © 2005, SAS Institute Inc. All rights reserved.

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CDISC SDTM Validation – Data Level
 Verifies that all required variable fields do notcontain missing values

 Detects occurrences of expected variable fields
that contain missing values

 Detects the conformance of all ISO-8601
specification assigned values; including date,time, datetime, duration, and interval types

 Notes correctness of yes/no and yes/no/null
responses,

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PROC CDISC
 Does NOT convert existing SDS 2.x content toSDTM 3.x representations.

 Does NOT automatically generate the SAS V5
XPORT file from the data source.

Copyright © 2005, SAS Institute Inc. All rights reserved.

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SAS CDISC ODM Viewer

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More information…
 Mailing List
XMLEngine@SAS.com

 Development Web Pages
Base SAS XML (Extensible Markup Language).htm(http://support.sas.com/rnd/base/index-xml-resources.html)
SAS 9_1_3 XML LIBNAME Engine User‘s Guide.htm(http://support.sas.com/rnd/base/topics/sxle913/usersguide913.htm)

 CDISC Documentation
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Thank You !

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