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FDA validator rule ID SD1148
SergiyP21
What version of validator and SDTM configuration?
Hi Jintao,
What version of validator and SDTM configuration do you refer?
Thank you,
Sergiy
j
Jintao
on January 7, 2020
The latest version via the COMMUNITY->VALIDATION RULES
Hi Sergiy,
The latest version we can find via COMMUNITY->VALIDATION RULES at this P21 website. The FDA Rules is also refer to the latest version. T
Thank you and best wishes,
Jintao
Below FDA validator rule is not implemented in the P21 tool. May I know the consideration behind?
FDA validator rule ID SD1148 - Start Date/Time of Treatment (EXSTDTC) variable value must be greater than or equal to Date/Time of Experimental Start Date (EXPSTDTC) in Trial Summary (TS) domain.