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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 cSDRG and ADRG apply to a single study. Sponsors have used these templates when creating a reviewer's guide for integrated Study Data and reviewer's guide for integrated Analysis Data. The template has to be changed in order to document the information for multiple studies. There is an opportunity to create a template for integrated Study Data and integrated Analyses Data. The project team will determine if this can be accomplished in one reviewer's guide or if there should be two separate reviewer's guide. This Deliverable includes a template, completion guidelines and example documents.

V1.0 – September-2023