u umang



Received this type of Warning after validate my datasets

FDAB011- Missing DOSENDTC Trial Summary Parameter

FDAB011- Missing DOSSTDTC Trial Summary Parameter

FDAB011- Missing PDOSFRQ Trial Summary Parameter

FDAB011- Missing SEXPOP Trial Summary Parameter

But as per SENDIG V3.1, this information is not mandatory. so why i am receiving this type of warning. Also PDOSFRQ not mentioned in TSPARMCD. Please suggest.


Forums: SEND

on October 28, 2020

Hi Umang, 

Pinnacle 21 provides study data validation for regulatory submissions to FDA, PMDA and NMPA. Each agency has their own additional requirements. For your example please refer to FDA Study Data Technical Conformance Guide.

Kind Reagrds,

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