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 reviewer’s guides for integrated study data and integrated analysis data. The template has to be changed to document the information for multiple studies. There is an opportunity to create a template for integrated study data and integrated analysis data. The project team will determine if this can be accomplished in one reviewer’s guide or two separate reviewer’s guides. Deliverables include a Template, Completion Guidelines and Example documents. |
Project Leads | |
|---|---|
Kiran Kundarapu, Lilly | |
Satheesh Avvaru, Alexion AstraZeneca Rare Disease | |
Randi McFarland, Ephicacy | |
Nicola Newton, PHUSE Project Coordinator |
Click above for the latest project status. |
Objectives & Deliverables | Timelines |
|---|---|
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 |