Integrated Analysis Data Reviewer’s Guide (iADRG) Package

Overview

The Integrated Analysis Data Reviewer’s Guide (iADRG) provides regulatory reviewers with additional context for integrated analysis datasets received as part of a regulatory submission. The iADRG is intended to describe analysis data submitted for integrated data summaries (Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), etc.). The iADRG purposefully duplicates limited information found in other submission documentation (e.g. the study protocols, integrated statistical analysis plan, Define-XML) to provide regulatory reviewers with a single point of orientation to the integrated analysis datasets. The submission of a reviewer’s guide does not obviate the requirement to submit a complete and informative Define-XML document to accompany the integrated analysis datasets.

Where some of the information is duplicated, it is advised to avoid redundancy between the iADRG and the Define-XML.

V1.0 – September-2023