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 Leads | |
|---|---|
Kiran Kundarapu |
, Lilly | |
Satheesh Avvaru |
, Alexion |
AstraZeneca Rare Disease | satheesh.avvaru@alexion.com |
Randi McFarland, Ephicacy | randi.mcfarland@ephicacy.com |
Nicola Newton |
, PHUSE |
Project Assistant |
iADRG template, completion guidelines and 2 examples
|
|---|
- Incorporated the PHUSE Leadership and Deliverable feedback into iADRG
- Proof reading complete for the iADRG Documents
- iADRG track to be published in July 2023
Q3 2024 |
|---|
|
| Objectives & Deliverables | Timelines |
|---|---|
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 |