Proc Cdisc 4p5n2m

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

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

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

ƒ David Handelsman • Solutions Strategist, Clinical R&D

ƒ Eric Brinsfield • Director Consulting Services

ƒ Anthony Friebel • XML Strategist, Platform R&D

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SAS Involvement ƒ Ed Helton • CDISC Board of Directors

ƒ David Handelsman • Solutions Strategist, Clinical R&D

ƒ Eric Brinsfield • Director Consulting Services

ƒ Anthony Friebel • XML Strategist, Platform R&D

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SAS Involvement ƒ Ed Helton • CDISC Board of Directors

ƒ David Handelsman • CDISC Industry Advisory Board

ƒ Eric Brinsfield • Director Consulting Services

ƒ Anthony Friebel • XML Strategist, Platform R&D

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SAS Involvement ƒ Ed Helton • CDISC Board of Directors

ƒ David Handelsman • CDISC Industry Advisory Board

ƒ Eric Brinsfield • ADaM Team

ƒ Anthony Friebel • XML Strategist, Platform R&D

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SAS Involvement ƒ Ed Helton • CDISC Board of Directors

ƒ David Handelsman • CDISC Industry Advisory Board

ƒ Eric Brinsfield • ADaM Team

ƒ Anthony Friebel • ODM Team • define.xml Team (principal contributor) • ODM/HL7 Harmonization Team

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

ƒ Continue to evolve built-in product

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SAS CDISC ƒ ƒ ƒ ƒ

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)

ƒ SAS CDISC ODM Viewer (Now only in English ) Module is available(free ). 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 ƒ ODM read/write capability (Production) ƒ SDTM content validation (Production) ƒ CRT-DDS - aka define.xml (Coming soon) ƒ 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 ;

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CDISC SDTM – ed Domains

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CDISC SDTM Validation – Metadata Level ƒ Verifies that all required variables are present in the data set

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

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

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CDISC SDTM Validation – Metadata Level ƒ Notes any permitted domain variables that are not in the data set

ƒ Verifies that all domain variables are of the expected data type and proper length

ƒ Detects any domain variables that are assigned a controlled terminology specification by the domain and do not have a format assigned to them Reports as an error any variables in the data set that are not defined in the domain

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CDISC SDTM Validation – Data Level ƒ Verifies that all required variable fields do not contain missing values

ƒ Detects occurrences of expected variable fields that contain missing values

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

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

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PROC CDISC ƒ Does NOT convert existing SDS 2.x content to SDTM 3.x representations.

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

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SAS CDISC ODM Viewer

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More information… ƒ Mailing List [email protected]

ƒ Development Web Pages Base SAS XML (Extensible Markup Language).htm

(http://.sas.com/rnd/base/index-xml-resources.html) SAS 9_1_3 XML LIBNAME Engine ‘s Guide.htm

(http://.sas.com/rnd/base/topics/sxle913/sguide913.htm)

ƒ CDISC Documentation Copyright © 2005, SAS Institute Inc. All rights reserved.

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Thank You !

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