Summary CBER is ready to support SEND data for non-clinical study submissions SEND is required for studies that

CDISC SEND is the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data, an FDA standard data format/terminology that is now required for submission …

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Original result values in SEND (--ORRES) are very useful to see the full text of the observation as collected. Standardization of --ORRES parses content into parent domain variables, with …

Original result values in SEND (--ORRES) are very useful to see the full text of the observation as collected. Standardization of --ORRES parses content into parent domain variables or …

Use the Tracker tool to monitor the status of shared reviews, send updates and email reminders, and invite additional reviewers. You can also add and change deadlines, end or delete …

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