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    Clinical Integrated Study Data & Analysis Data Reviewer's Guide

      Clinical Integrated Study Data & Analysis Data Reviewer's Guide

      Oct 01, 2025

      Project Scope 

      The 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. Deliverables include a template, completion guidelines and example documents.

      Project LeadsEmail

      Kiran Kundarapu, Lilly

      kiran.kundarapu@lilly.com

      Satheesh Avvaru, Alexion AstraZeneca Rare Disease

      satheesh.avvaru@alexion.com

      Randi McFarland, Ephicacy

      randi.mcfarland@ephicacy.com

      Nicola Newton, PHUSE Project Coordinator

      nicky@phuse.global

      CURRENT STATUS (Updated Quarterly) 

      • Finishing team review of completion guidelines​​
      • Provide icSDRG package for public review​
      Objectives & DeliverablesTimelines

      iADRG template, completion guidelines and 2 examples

      Q2 2023

      icSDRG project: integrated clinical Study Data Reviewer’s Guide (icSDRG) Template, Completion Guidelines and Example 

      Q2 2024
      , multiple selections available,
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