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Automation Through CDISC Standard Models: eProtocol, Data Submission, and Safety Reporting
Program Code:
382
Date:
Wednesday, June 27, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Richa Singh, Cognizant Technology Solutions Corporation, India
PRESENTER
(S):
Richa Singh, Cognizant Technology Solutions Corporation, India
Wim Verreth, SGS Life Science Services, Belgium
Janet Stuelpner has provided programming support in the areas of clinical trials and outcomes research in the pharmaceutical industry. She joined SAS Institute as a Solution Architect in the Health and LIfe Sciences Group and specializes in Data Integration and Data Quality.
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Description
This symposium will include discussions on automated solutions based on CDISC and CDASH data standard models that can bring significant effort reduction and process optimization across the clinical data management framework.
Learning Objectives:
Discuss the benefits of using eProtocol for the study configuration in Clinical Data Management Sysytems (CDMS) or Electronic Data Capture (EDC)
Describe the benefits of single source SAE data collection via eDC in relation to centralized monitoring, a remote evaluation carried out by clinical/medical monitors
Identify the limitations associated with manual management of critical chain of custody documentation.