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Copyright © 2008, SAS Institute Inc. All rights reserved.
SAS offers technology to facilitate working with CDISC standards : the metadata perspective.Mark Lambrecht, PhDPrincipal Consultant, Life SciencesSAS
Copyright © 2008, SAS Institute Inc. All rights reserved.
Agenda
§ SAS actively supports CDISC standards
§ Tools’ approach (PROC CDISC, XML) : the foundation
§ Clinical DI : building the house• The industrial approach in CDISC mapping : clinical DI• Now that the metadata is gathered
§ What will SAS bring next ?
Copyright © 2008, SAS Institute Inc. All rights reserved.
SAS actively supports CDISC standards
Copyright © 2008, SAS Institute Inc. All rights reserved.
Copyright © 2008, SAS Institute Inc. All rights reserved.
Copyright © 2008, SAS Institute Inc. All rights reserved.
SAS and CDISC
§ SAS supports the effort to replace v5 xport file type with multiple modern, extensible XML file type
§ SAS is actively involved in multiple modeling committees:• SDTM, ADaM, Protocol, ODM, etc.
§ SAS has invested, and will continue to invest, in a variety of CDISC-enabling technologies
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Delivery format : the old
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Delivery format : the new
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Tools approach : the foundation
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XML
§ XML libname engine• Manipulating XML• ODM native mode• XML Mapper : mapping rectangular format to/from
hierarchical XML
§ XML conformance : 3 levels
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SAS XML Libname Engine ODM Syntax
Load data from ODM XML into SAS data set
Declare input source
Declare output source
Save data from SAS data set into ODM XML
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PROC CDISC
§ Input CDISC ODM XML files to SAS data set(s)
§ Output SAS data set content to CDISC ODM XML
§ Validates CDISC SDTM content against model
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PROC CDISC validation for SDTM
§ Verifies all required variables are present
§ Identifies dataset variables not defined in domain
§ Identifies missing, but expected, domain variables
§ Identifies missing, but permitted, domain variables
§ Verifies variables are of expected type and length
§ Identifies missing, but expected, controlled terminology (formats)
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Proc CDISC Capabilities
§ Input CDISC ODM XML files to SAS data set(s)
§ Output SAS data set content to CDISC ODM XML
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Staying Current with Proc CDISC
§ http://www.sas.com/apps/demosdownloads/proccdisc_PROD_9_sysdep.jsp?packageID=000369
§ www.support.sas.com, then search on CDISC
Screenshot from 15-April-200815
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Proc CDISC Input Syntax for ODM
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Proc CDISC Output Syntax for ODM
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Proc CDISC for SDTM: Metadata Validation§ Verifies all required variables are present
§ Identifies dataset variables not defined in domain
§ Identifies missing, but expected, domain variables
§ Identifies missing, but permitted, domain variables
§ Verifies variables are of expected type and length
§ Identifies missing, but expected, controlled terminology (formats)
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Proc CDISC for SDTM: Data Validation
§ Verifies that required variables do not contain missing values
§ Identifies expected variables that contain missing values
§ Verifies conformance of all ISO-8601 specification assigned values
§ Notes correctness of yes/no and yes/no/null responses
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Proc CDISC Syntax for SDTM
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CDISC viewer
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http://www.cs.utah.edu/~draperg/cartoons/jb/mainframe.html
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Clinical DI : building the house
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Challenges
§ Globalization of reporting tools
§ Implementation of CDISC
§ EDC/CDMS system integration
§ More restrictive regulator demands
§ Data standardization
§ Validation
§ Integration of study-databases
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§ CDISC models• Technology and tools need to support SDTM/ADAM model
− Version management– SDTM version
− Internal SDTM model enhancements− Submission driven transformation
– Define.xml
External drivers
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Internal drivers
§ Cooperation• Structure of repositories
− Parent / Child• Exchange of programs• Exchange of skills• Global collection and managing of metadata• Transparency
− Visualization of data streams is possible− Reporting of metadata− SAS code is generated and can be viewed
• Security
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SAS 9 platform
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Clinical DI
§ Data Integration Server enables easy integrationof heterogenous clinical data into CDISC standards
§ SAS DI uses the Open Metadata Architecture
§ Using DI, individual programmer’s studyknowledge is documented in the metadata and made available for the whole organization
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Operational Data
Analysis
Standardization
Validation
Aggregation
Submission
SAS Metadata Server
Impact of Metadata in Clinical Data Integration
Documents
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Clinical DI
“Clinical DI brings the CDISC knowledge stored in peoples individual minds into a centralized IT environment, accessible for exploitation and decreasing the time needed for submission of clinical trial data”
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Clinical DI Standardization Components § Folder structure
• Supports best practices• Based on SDTM IG 3.1.1• Includes:
− Controlled Terminology− Custom Domains− Model Classifications− Published Domains− Relationship Datasets− Trial Design Datasets
§ SDTM domain metadata• Published domains, Trial Design Domains, and relationship
datasets
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SAS Data Integration Server
§ Visual Standardization Process
§ Drives relationships and associations
§ End up with standardized data AND specific metadata about how data was created
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Clinical Data Integration Features Overview
§ SAS Management Console• Clinical DI Install/Update Plug-in• Study Manager Plug-in
§ DI Studio• Register Domains• SDTM Domain Designer• Suppqual Generator
§ Reports• Publish SDTM Library• Change Management Audit Report• SDTM Model Discrepancy• Model Analysis• Define.xml (beta)
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SDTM Implementation Guide§ Centrally Accessible
§ Contains All Domains• General Purpose• Special-Purpose• Special-Purpose Relationship• Trial Design
§ Each Domain Contains• Table Structure• CDISC Table Level Metadata• CDISC Column Level Metadata
§ Allows For Custom Domain Expansion
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Domain Level Metadata
SDTM Implementation Guide
Column Level Metadata (all columns)
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Workflow and Change Management
§ Clinical DI components to support best practices in workflow:• Clinical Data Integration component installation and
administration• Setup a study and capture study metadata• Register domain to a study based on the standard
model definition• Generation of suppqual domains based on model
§ Metadata can be leveraged for reporting to support business process
§ Change management through user project folders
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Study Manager
§ Registers repositories as studies
§ Stores basic study level metadata
§ Associates a SDTM version with the study
§ Drives consistency in using all Clinical DI plug-ins
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CDISC Metadata Reporting is Domain Driven
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PROC CDISC – CRT-DDS (Define.xml)
PROC CDISC DEFINE.XML
METATABLE
METACOLUMN
SUPPDOC
CRF
METHOD
VALUELIST
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SAS Clinical Data Integration Benefits§ Positions the customer to build reusable data
management, analysis and reporting processes for clinical studies
§ Follows the CDISC STDM Implementation Guide v3.1.1 (and will support v3.1.2 when it is finalized). SDTM Model Verification.
§ Allows for flexibility and customizations necessary to implement SDTM+/-
§ Enables control and security using SAS Management Console
§ CDISC Metadata Reporting is Domain Driven
§ Change Management Auditing
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PROC CDISC or Clinical DI ?
Complete technology for CDISC standarization and submission
Final conversion of rectangular SAS table/XML format
Primary objective
Explicit in metadata/DIImplicit in code, but complex to retrieve
Impact analysis
MediumNoneChange management
Globally accessibleinfrastructure
For use in local code developmentGlobally accessible ?
Can be attached to data or in external dictionary
Externally storedWhere are column mappings stored ?
High : Copy/Paste, Import/Export, Promotion/Replication, Parameterized processes, web services
Low to medium (macro’s)Re-usability
FastModerateSpeed of development
Clinical DIPROC CDISCTopic
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PROC CDISC or Clinical DI ?
Fully customizable and standardreports provided
Only partiallySDTM data validation
Full automated access to metadata, including processes, infrastructure and external documents (CRF,…)
Partial ; more to come.CDISC metadata validation
Clinical DIPROC CDISCTopic
SAS Metamodel allows us to represent CDISC standards as “DeployedSoftware” that can be linked to studies\projects for integrated consistency
Difficult to manage and see what code used what version of CDISC models
Versions of CDISC standards/ internal
Well formed code, integrated documentation, synchronized transformations
Paper-based systemValidation of code
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We did it before: implementation of clinical DI
§ Evaluation methodology : CDISC-readiness
§ Ingredients• Consultants :
− SAS Clinical DI and CDISC consultants and experts− Trained and recognized partners
• Technology• EDC, CDMS, relational databases, ERP, CTMS
§ Critical success factors
§ Risk analysis
§ Adaptation on CDISC metadata (SDTM+/-)
§ Value-level metadata, codelists, specific descriptions, custom domains, supplemental qualifiers
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What will SAS bring next ?
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Next version of PROC CDISC
§ ODM 1.2 and 1.3 read/write
§ Define.xml (CRT-DDS) 1.0.0 read/write
§ Validation for SDTM 3.1.1 and 3.1.2• Compliance checks• Custom checks• Available for 9.1.3 and 9.2
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Next version of clinical DI Server brings you
§ A SAS-supported R&D solution
§ More complex and custom validation SDTM content and structure
§ CRT-DDS (define.xml) creation
§ CDISC Models, Version and Format support for Clinical DI Server
§ Controlled terminology
§ ADaM (2.0)
§ LAB, SEND, Protocol Representation, CDASH
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SAS Universal Viewer
§ Will replace CDISC viewer and will support all CDISC file formats
§ Hierarchical and tabular formats viewing
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New ISO8601 formats in base SAS 9.2
§ New series for writing, reading ISO8601 dates, times and *new* intervals (duration).
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§ Committed to bringing you CDISC tools and full solutions
§ Continuous R&D effort
§ Working together with customer because of many CDISC-trained consultants and partners in the field
§ Domain knowledge and industry advisory role
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