I have created simplified TS.xpt because study started before 17th Dec 2016. but regulatory colleague has received FDA Technical rejection Error 1736 that describe that we have to submit dm.xpt and define.xml. Because of FDA study date technical rejection criteria March 2021, we got this Error. is it mandatory to include both file even i have started study before date. Please suggest.
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I have created simplified TS.xpt because study started before 17th Dec 2016. but regulatory colleague has received FDA Technical rejection Error 1736 that describe that we have to submit dm.xpt and define.xml. Because of FDA study date technical rejection criteria March 2021, we got this Error. is it mandatory to include both file even i have started study before date. Please suggest.