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Safety Signal Detection

Based on our real-time potential clinical significance detection based on CTCAE criteria on an observation, it flags the data requiring further assessment as it seems to be a safe/acceptable range as defined by CTCAE. The data manager will be prompted to associate flagged observation to an adverse event or medical history to ensure that the value has context. This linkage provides traceability between the observation and adverse event. This entire workflow is next generation, available today as part of Protocol First EDC system - standard. All of this data is exported in industry standard CDISC SDTM that can be analyzed by the Data Management and BioStats team.

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Today in current EDC systems, the workflow stops with a range check with potentially a query being fired. A manual process occurs between the site data management, monitor, and data manager to ensure that unsafe value has an “associated” adverse event. Unfortunately, the EDC lacks any way to associate this AE with this unsafe value leading to hours of repetitious listing reviews because there is no traceability to find that associated adverse event and hope that’s the AE that the site data manager was