Quality and Integrity of Clinical Study Data in the Compliance with GCP: From Patient to Data Submis

Venue: Shanghai Everbright Convention & Exhibition Center

Location: Shanghai, ??, China

Event Date/Time: Oct 25, 2011 End Date/Time: Oct 26, 2011
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This workshop will provide you with principles and processes involved in the data management life cycle and relationship of data process system with the drug development, including computerized systems, regulatory standards, computerized systems validation, data preparation and submission, as well as how to plan and conduct a data management plan and monitor data integrity and accuracy in the clinical study life cycle. You will also learn the role that clinical data management plays in the eSystem world.
• Regulatory environment and standards and how they relate to data management disciplines
• Experiences and roles of clinical data managers
• Data management-related challenges/opportunities with new innovative designs in clinical research
• Effective communications and interactions between data management professionals and statisticians, programmers, and other clinical professionals
• Basic concepts and expectations of data quality and integrity and their improvements governed by GCP standards
• Protocol development and CRF design
• Best practice in eCRF development and e-systems validation
• Document preparation of data management in clinical studies
• CSR/CTD completion
• Validation of the reliability of medical records in clinical study
• E-submission process – from design to implementation
• EDC system enhancement and integration
At the end of the workshop, participants should be able to
• Understand the regulations and GCP practices as they impact data management
• Describe in-depth the changing role and challenges of the data manager as well as more efficient management and communication of data management in the e-system world
• Outline the DM focus on protocol review and CRF design
• Understand the importance of communication, standardization and documentation in the DM prospective
• Learn the “best practice” for DM operation and process
• Identify e-system enhancements and applications in the industry
• Prepare the participants to contribute positively to a project and implementation of group sequential design and analysis (interim analysis)
• Understand the common statistical approaches to multiple comparisons and multiple endpoints in the context of controlling overall false positive finding rate
• Trial data managers
• Trial project managers
• Trial monitors
• Trial quality assurance and
quality control professionals
• Biostatisticians
• Clinical computer system users
• Trial auditors
• Clinical development professionals
• Clinical regulatory affairs
• Clinical researchers and study coordinators
• Clinical information technology professionals
• Trial programmers

Event Code:


Room 115 Block A Gateway Plaza