Versions Compared

Key

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


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 Oncology

kkundarapu@loxooncology.com

Satheesh Avvaru, Alexion AstraZeneca Rare Disease

satheesh.avvaru@alexion.com

Nicola Newton, PHUSE Project Assistant

nicky@phuse.global


Status
colourBlue
titleCurrent Status
Q2 Q1 2024

  • Incorporating PHUSE CSS 2023 comments into the icSRDG draft template

  • Started draft icSDRG 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