Pinnacle 21 community warning

u umang

on October 28, 2020

Hii

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.

Thanks

Forums: SEND

Sergiy

on October 28, 2020

P21

Hi Umang, Pinnacle 21…

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,
Sergiy