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eSource and Digital Data Management
Session Chair(s)
Judy Jiang
China
As technology evolves, we have a great variety of electronic systems and devices to support data collection in clinical trials for safety,efficacy and all the data required. Take a live example, in a clinical trial a data manager might need to deal with data come from EDC, IRT, central lab, eCOA, special device and so on. We also need to ensure the data integration between the systems works well, ensure safety data flow timely for AE reporting to agencies, ensure the dataflow from database to database is correctly designed and mapped according to the CDISC standards. It could be very complicated especially we have many technology vendors available in the market and the study could have many change requests to address the evolving clinical needs to answer the scientific questions we want to address from a clinical study. How is the current situation? What is the trend for the future? What are the common challenges we have? What are some best practices we can leverage? In this session, we will have experts representing Data Management and the agency to share their insights and experiences.