End-to-End Study Management using BRIDG
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© CDISC 2013
Peter SmilanskyHead of Consulting Practice, HCL Life Sciences
Jonathan StieglitzSenior Business ArchitectConsulting Practice, HCL Life Sciences
Jian ChenPresident, EDETEK, Inc.
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End-to-End Study Management using BRIDG
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© CDISC 2013 3
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?
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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
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eCRF:• Common Activities• Associated Forms• BRIDG Mappings
BRIDG Defined Activities
BRIDG Mapping
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TLFs• Common Endpoints• Reporting
Templates• BRIDG Mappings
BRIDG Defined Activities
BRIDG Mapping
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Step 2 : Study Development - Protocol
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Study Protocol Versions are developed, and are associated with
Defined Activities
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Step 3a : Study Design – Data Collection
• Define Arms• Define Epochs• Define Segments• Define Cells• Define Study Events• Define Workflow
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Study Design Model (SDM)
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Study 3a : Generate eCRF
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eCRF Design
EDC
eCRF Designer
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
• Study Initiation Instantiate Study Activities
• Site Initiation Instantiate Study Site
• Subject Enrollment Instantiate Study Subject Instantiate Scheduled Activities
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Planned Activity Scheduled Activity
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Step 5 : Study Conduct
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Step 5 : Creation of BRIDG Data
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Auto-Generated based on Library and Study Design
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Step 5 : From BRIDG to Other Standards
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BRIDG to other physical structures can be pre-built
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Step 6 : Study Analysis
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Statistical analysis, reports, and visualization will leverage standardized data
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Questions?
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