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CDISC BRIDG Implementation: A Model for System Interoperability and as a Data Base Model

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
309

Room Number:
30CD

Level:
Advanced

Type:
Session

Title:
CDISC BRIDG Implementation: A Model for System Interoperability and as a Data Base Model

Chair(s):
Terry D. Hardin
Director, Information Management
PAREXEL International, United States

Description:
This session will discuss the impact that the Biomedical Research Integrated Domain Group (BRIDG) is having on data as an asset, from study set-up to analysis and reporting. We will examine moving from BRIDG as a concept to generation of physical artifacts, and how this industry initiative is changing the structure of data stored in clinical data repositories. Case studies will be presented examining the pros and cons of BRIDG implementations, from a basis for messaging structures to data base models, and consumption of BRIDG-based data in analysis and reporting.

Learning Objective(s):
Discuss BRIDG from an implementation perspective; Identify the challenges faced when moving from BRIDG to a database or messaging model; Explain how to generate a database model from BRIDG for use in a clinical data repository.

Presentation(s) & Speaker(s):
A Case Study in CDISC BRIDG Implementation: BRIDG as a Canonical Data Model
Terry D. Hardin
Director, Information Management
PAREXEL International, United States

A Case Study in BRIDG Implementation: Leveraging BRIDG as a Database Model for Clinical Trials
Smita Hastak, MS
Chief Executive Officer
Samvit Solutions, LLC, United States

Crossing the BRIDG: Some Reviewer Thoughts and Perspectives
Stephen E. Wilson, DrPH
Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
FDA, United States