Reviewer’s Guide

SCiAN will produce the SDTM reviewer’s guide (SDRG) once the database and SDTM specifications have been finalized and all validation issues have been addressed.

The SDRG is intended to provide additional context and act as a single point of orientation for the SDTM datasets.  All SDTM data submitted for an individual study in the Module 5 clinical section of the eCTD are described.