Clinical Integrated Study Data & Analysis Data Reviewer's Guide
- Former user (Deleted)
- Nicola Newton
- Former user (Deleted)
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 |
CURRENT STATUS Q4 2024 |
|---|
1. Develop draft icSDRG Completion Guidelines. 2. Provide icSDRG Template, Example and Completion Guidelines for review. |
| 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 |