Clinical Integrated Study Data & Analysis Data Reviewer's Guide

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 Assistant

nicky@phuse.global

CURRENT STATUS 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

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

Q2 2024