Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Image Modified


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


Consolidate and address comments from

Status
colourBlue
titleCurrent Status
Q3 2023

2024

  • Presented icSDRG template at the CSS and optimise the icSDRG template.Kick off sub-groups for Completion Guidelines and Example.If possible, send the iADRG for FDA review. . 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