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Copyright © 2014, SAS Institute Inc. All rights reserved. SUPER DEMO: THE INTEGRATION OF SAS DRUG DEVELOPMENT AND SAS CLINICAL DATA INTEGRATION JULIE MADDOX SAS INSTITUTE PHARMASUG 2014

The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Page 1: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

Copyr i g ht © 2014, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

SUPER DEMO: THE INTEGRATION OF SAS

DRUG DEVELOPMENT AND SAS CLINICAL

DATA INTEGRATION

JULIE MADDOX

SAS INSTITUTE

PHARMASUG 2014

Page 2: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

What Is SAS Drug Development?

Key Features:

Secure centralized content repository

Integrated SAS development and

execution environment

Auditing and traceability

Work and task management

Job management and scheduling

Collaborative work environment

Page 3: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

What Is SAS ClinicalData Integration?

Provides support for

CDISC standards,

SEND, SDTM,

ADaM, Define

Centralized metadata

management

Visual transformation

tools

Page 4: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration

Shared Environment: Metadata Server and SAS

Workspace Server

Shared workspace for programs and data

Dynamic Library/File assignments using macro variable

Code developed in CDI executes without changes

inside SDD

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Page 5: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Hosted SAS Drug Development & SAS Clinical Data Integration

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Client

Clinical Data

Integration

Via Terminal Server

Application Servers

SAS Metadata

Server

SAS Workspace

Servers

Shared SAS Servers

SAS Drug

Development

Via Browser

Page 6: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Scenario - Creating the Define.xml File

SAS Clinical Data Integration,

provides a CDISC-Define

transformation to build the

define.xml file from the study

domain metadata.

Page 7: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

CDI Job to create Define File

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Provide list of

Domain tables

and location

to include in

the define file

Provide name

and location

of define file

CDI Document

Object

SAS Library

Object

Page 8: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration

Shared Environment: Metadata Server & SAS

Workspace Server

Shared workspace, for programs, data

– Macro variable identifies the location of the

root-level folder for the SDD Workspace

– Allows for the same program to run in CDI, in the

SDD Workspace as well as the SDD Repository

without any modifications.

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Page 9: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

_sasws_ Macro Variable

This macro variables can be referenced in SAS programs.

LIBNAME statements

FILENAME statements

Other SAS statements

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libname sdtm "&_sasws_/QAGPharma/PainXD-Study101/Files/Data/sdtm";

filename define "&_sasws_/QAGPharma/PainXD-Study101/Files/define.xml";

%include "&_sasws_/QAGPharma/PainXD-Study101/Files/Macros/setup.sas";

%let StudyPath=&_sasws_/QAGPharma/PainXD-Study101;

Page 10: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Define.xml File Properties

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Page 11: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

SAS Library Properties for SDTM domains

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Page 12: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Develop Code in CDI, Save directly into SDD

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Page 13: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Saved CDI Code appears in SDD workspace

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Page 14: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Execute CDI Code in SDD – no code changes required

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Page 15: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Define file is created in the Specified folder

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Page 16: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Check in Program into Repository

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Mark program for addition and check it in to repository

Page 17: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

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Copyr i g ht © 2012, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

Advantages of a Hosting SAS Drug Development & SAS Clinical Data Integration

Shared Environment: Metadata Server and SAS

Workspace Server

Shared workspace for programs and data

Dynamic Library/File assignments using macro variable

Code developed in CDI executes without changes

inside SDD

17

Page 18: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

Copyr i g ht © 2014, SAS Ins t i tu t e Inc . A l l r ights reser ve d .sas.com

QUESTIONS ???

Page 19: The Integration of SAS Drug Development and SAS …...Advantages of Hosting SAS Drug Development & SAS Clinical Data Integration Shared Environment: Metadata Server & SAS Workspace

Copyr i g ht © 2014, SAS Ins t i tu t e Inc . A l l r ights reser ve d .

SAS LIFE SCIENCE ANALYTICS

FRAMEWORK

JULIE MADDOX

SAS INSTITUTE

PHARMASUG 2014