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Embracing Change: The New Face of Clinical Data Management

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 17, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
265

Room Number:
33AB

Level:
Intermediate

Type:
Symposium

Title:
Embracing Change: The New Face of Clinical Data Management

Chair(s):
Maryanne C. Nicosia, MS
Director, Clinical Data Management
Neurocrine Biosciences Inc., United States

Description:
As clinical research changes, so must the role of the clinical data manager (CDM), who is being asked to do more than ever to ensure data quality. This symposium will provide ideas on how to leverage a clinical data repository to create efficiencies in the discrepancy management and serious adverse event (SAE) reconciliation processes. Attendees will also learn through case studies how to leverage existing data management processes on eSource studies in order to ensure an efficient study start-up, decreased data review time, and high quality data. This symposium will also focus on identifying the expanded skill set required of the CDM and how those currently in the CDM role can ensure that they have the skills needed to be successful in the changing clinical development environment.

Learning Objective(s):
Identify the ways a clinical data repository can facilitate efficient discrepancy management and serious adverse event (SAE) reconciliation; Discuss the benefits, challenges, and opportunities for data management when conducting eSource studies; Describe the new role of data management in the changing study development environment.

Presentation(s) & Speaker(s):
Leveraging a Clinical Warehouse for Discrepancy Management and Adverse Event Reconciliation
Subra Subramanian, MBA
Director, Product Strategy
Oracle Health Sciences, United States

eSource: Clinical Data Manager’s Tale of Three Studies
Maura Bearden
Clinical Data Manager
DATATRAK, United States