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, Loxo Oncology |
| .avvaru@alexion.com | |
Randi McFarland, Ephicacy | randi.mcfarland@ephicacy.com |
Nicola Newton, PHUSE Project Assistant |
- Continued to work on the iADRG deliverable package, with the plan to send to the Steering Committee in December and then public review starting in January.
- Presented the iADRG template and the development of the Example Documents and Completion Guidelines at the PHUSE CSS 2021.
Q2 2024 |
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| Objectives & Deliverables | Timelines |
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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 |