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 of …

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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 possibly …

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 comment …

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 reviews, and start …

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