DIA 48th Annual Meeting
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Electronic Data Capture (EDC): How Much Quality Is Enough?
Track : Track 19: SIAC Showcase
Program Code: 270
Date: Tuesday, June 26, 2012
Time: 3:30 PM to 4:30 PM  EST
CHAIR :
Ellen Hinkle, MA, Clinical Data Specialist II, Vertex Pharmaceuticals
PRESENTER (S):
 Scott Brand, KAI Research Inc., United States
 Ellen Hinkle, Vertex Pharmaceuticals, United States
Description
This is a complicated question that challenges many clinical study teams, particularly with respect to Electronic Data Capture (EDC) systems. In an effort to provide direction to these teams, a Clinical Data Management (CDM) SIAC Working Group is exploring the changing expectations of data quality as a result of EDC and the processes, procedures and tools recommended to optimize data quality. Developed by the Clinical Data Management (CDM) SIAC.

Learning Objectives:
Describe the challenge associated with determining how much data quality is adequate for EDC systems
Discuss case studies on what has worked and what has not worked in different organizations
Explain the EDC vendors' view on data quality.


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