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Electronic Data Capture (EDC): How Much Quality Is Enough?
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 is Director of Strategic Planning and Quality Assurance at KAI Research Inc. For over 25 years he has been involved in clinical IT developing computer systems to support clinical research for the government and industry. His interests are in EDC, QA and pharmacovigilance
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After a successful career as a professional musician and educator, Ellen Hinkle began working as a clinical data manager. With 14 years of industry experience, she is currently a Clinical Data Specialist II at Vertex Pharmaceuticals, where she leads trials in HIV-HCV coinfection.
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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.