...
...
...
...
...
...
...
...
...
...
...
...
...
...
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 |
| ||||||
---|---|---|---|---|---|---|
|
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 |