Project | ScopeScope |
The cSDRG and ADRG apply to a single studysingle 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
icSDRG template, completion guidelines and an example
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- Received comments from Public Review for the iADRG Template and supporting documents
- Currently analysing feedback comments to make applicable updates to the iADRG
Q3 2024 |
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| 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 |