the integration of sas drug development and sas …...advantages of hosting sas drug development...

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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

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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

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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