Pres2_End-to-End Study Management using BRIDG

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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.
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BRIDG Overview
 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
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Why BRIDG?
News: BRIDG
CDR Relational
Structure Exists!
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BRIDG – Bridging Clinical Research and Health Care
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Managing Study using BRIDG
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Step 1 : Create Common Libraries – eCRF & TLF
eCRF:
• Common Activities
• Associated Forms
• BRIDG Mappings
BRIDG Defined
Activities
BRIDG Defined
Activities
TLFs
• Common Endpoints
• Reporting
Templates
• BRIDG Mappings
BRIDG Mapping
BRIDG Mapping
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Step 2 : Study Development - Protocol
Study Protocol Versions are
developed, and are associated with
Defined Activities
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Step 3a : Study Design – Data Collection
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Define Arms
Define Epochs
Define Segments
Define Cells
Define Study Events
Define Workflow
Study Design Model (SDM)
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Study 3a : Generate eCRF
eCRF
eCRFDesign
Designer
EDC
EDC
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Step 3b : Study Design - Analysis
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Study 3c : Study Design - Reporting
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Step 3c : Study Design - Monitoring
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Step 4 : 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
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Step 5 : Study Conduct
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Step 5 : Creation of BRIDG Data
Auto-Generated based on Library and Study Design
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Step 5 : From BRIDG to Other Standards
BRIDG to other physical structures can be pre-built
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Step 6 : Study Analysis
Statistical analysis, reports, and visualization will leverage standardized data
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Questions?
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