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: