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SDSP
July 25, 2016
December 17, 2016, is less than five months away.
As we all know by now, studies starting on or after that date must be submitted to the Food & Drug Administration electronically. They must also utilize the most-recent FDA-acknowledged version of data standards.
To support the latter point, FDA is requesting that sponsors submit a Study Data Standardization Plan (SDSP) as part of the IND application.
With time running out quickly, two big questions have taken on a new urgency:
