SEND Standard for the Exchange of Nonclinical Data. Basel, Switzerland 2014 SDE Christina Würmlin – PDS Inc. What is SEND?. In development >10 years by CDISC along with FDA 2012: FDA granted authority to establish & require a standard electronic format for INDs, NDAs, ANDAs , BLAs
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Basel, Switzerland 2014 SDE
Christina Würmlin – PDS Inc.
Clin obs, ophth
SEND dataset consisting of different domains (separate XPT files) and a define file (XML & PDF).
Final Study Report
Rest of Study Data
(lowercase) and other findings (neoplasms) mapped to controlled terminology (uppercase).
(1) FDA, CDER, CBER: Draft Study Data Technical Conformance Guide, February 2014