Protocol Deviation- Site level deviations

l Liron

on January 21, 2016

Hi,

As protocol deviations presented in the DV domain hold subject level deviations, some deviations recorded in the study are Site level deviations. Additionally some are related to the site personnel and are not specific to any of the study subjects.

How would you record those in SDTM?

Thanks,

Liron

Forums: SDTM

s Sergiy

on January 28, 2016

Hi Liron, Protocol

Hi Liron,

Protocol Deviations are captured in DV domain. Current SDTM standard is designed for subject data with the only exception of Trial Design info.

If there are any Site level Protocol violations I would suggest to document them in Clinical Study Report (CSR) and in Study Data Reviewer's Guide (SDRG) if applicable.

Kind Regards,

Sergiy

l Liron

on February 1, 2016