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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

© 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

© CDISC 2013

Why BRIDG?

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News: BRIDG CDR Relational Structure Exists!

© CDISC 2013

BRIDG – Bridging Clinical Research and Health Care

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© CDISC 2013

Managing Study using BRIDG

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© CDISC 2013

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

© CDISC 2013

Step 2 : Study Development - Protocol

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Study Protocol Versions are developed, and are associated with

Defined Activities

© CDISC 2013

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)

© CDISC 2013

Study 3a : Generate eCRF

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eCRF Design

EDC

eCRF Designer

EDC

© CDISC 2013

Step 3b : Study Design - Analysis

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© CDISC 2013

Study 3c : Study Design - Reporting

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© CDISC 2013

Step 3c : Study Design - Monitoring

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© CDISC 2013

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

© CDISC 2013

Step 5 : Study Conduct

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© CDISC 2013

Step 5 : Creation of BRIDG Data

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Auto-Generated based on Library and Study Design

© CDISC 2013

Step 5 : From BRIDG to Other Standards

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BRIDG to other physical structures can be pre-built

© CDISC 2013

Step 6 : Study Analysis

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Statistical analysis, reports, and visualization will leverage standardized data

© CDISC 2013

Questions?

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