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End-to-End Study Management using BRIDG
Peter Smilansky
Head of Consulting Practice, HCL Life Sciences
Jonathan Stieglitz
Senior Business Architect
Consulting Practice, HCL Life Sciences
Jian Chen
President, EDETEK, Inc.
© CDISC 2013 2

 BRIDG Biomedical Research Integrated Domain Group Model
 The BRIDG Model is an information model, representing a shared view of the concepts of protocol-driven clinical research. This structured information model is being used to support development of data interchange standards and technology solutions within the biomedical/clinical research arena and between research and the healthcare arena.
 BRIDG is a platform for expressing the processes and data concepts of clinical research in a consistent manner across all the stakeholders
 Stakeholders include CDISC, FDA, NCI and HL7
 Open development model – anyone can contribute
 BRIDG is the vehicle to harmonize existing CDISC standards
(SHARE)
 BRIDG persistence can physically store all Clinical Research Data
© CDISC 2013 3

News: BRIDG
CDR Relational
Structure Exists!
© CDISC 2013 4

Bridging Clinical Research and Health Care
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Create Common Libraries – eCRF & TLF
BRIDG Defined
Activities eCRF:
• Common Activities
• Associated Forms
• BRIDG Mappings
BRIDG Defined
Activities
TLFs
• Common Endpoints
• Reporting
Templates
• BRIDG Mappings
BRIDG Mapping
BRIDG Mapping
© CDISC 2013

Study Development - Protocol
© CDISC 2013
Study Protocol Versions are developed, and are associated with
Defined Activities
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Study Design – Data Collection
• Define Arms
• Define Epochs
• Define Segments
• Define Cells
• Define Study Events
• Define Workflow
Study Design Model (SDM)
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Generate eCRF
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EDC
EDC
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Study Design - Analysis
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Study Design - Reporting
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Study Design - Monitoring
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Study Initiation and Subject Enrollment
Planned Activity Scheduled Activity
• Study Initiation
 Instantiate Study Activities
• Site Initiation
 Instantiate Study Site
• Subject Enrollment
 Instantiate Study Subject
 Instantiate Scheduled Activities
© CDISC 2013 14

Study Conduct
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Creation of BRIDG Data
Auto-Generated based on Library and Study Design
© CDISC 2013 16

From BRIDG to Other Standards
BRIDG to other physical structures can be pre-built
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Study Analysis
Statistical analysis, reports, and visualization will leverage standardized data
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