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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, Loxo Oncologykkundarapu@loxooncology 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 Assistant

nicky@phuse.global


  • Incorporated the  PHUSE Leadership and Deliverable feedback into iADRG
  • Proof reading complete for the iADRG Documents 
  • iADRG track to be published in July 2023

    Status
    colourBlue
    titleCurrent Status
    Q2 2023

    Q3 2024

    • Presented icSDRG template at the CSS. Received and incorporated feedback 2.

    • Moved back to Example document.







    Objectives & DeliverablesTimelines

    iADRG template, completion guidelines and 2 examples

    Q2 2023

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

    Q2 2024