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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. |
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- iADRG template completed.
- icSDRG template in progress.
- Identified team members to work on example documents and completion guidelines.
- iADRG example document draft in progress.
- FDA is on board to support the project.
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Objectives & Deliverables | Timelines |
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Draft Reviewers Guide(s) Template | Dec-2020 |
Draft Examples | Apr-2021 |
Draft Completion Guidelines | May-2021 |
Public Review | Jun-2021 |
Publish final deliverable | Aug-2021 |
FDA Review | Pending FR Notice |
Project Members | Organisation |
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Abhilash Vasu Chimbirithy | Merck |
Adie Bonwick | GSK |
Anand Jayaraman | Merck |
Anita Baniya | PPDI |
Aron Anton | PPDI |
Athenkosi Nkonyeni | Industry |
Aurora Liao | Industry |
Bidhya Basnet | Genentech |
Carey Smoak | S-cubed |
Charanjit Kahlon | Softworld |
Christine Rossin | Pfizer |
Ellen Asam | Merck |
Ghanshyam Jangid | Merck |
Hanne Ellehoj | Lundbeck |
Imran Syed | Bayer |
James Gaiser | Prometrika |
Janet Low | Merck |
Jane Lozano | Eli Lilly |
Jian Huang | Celgene |
Kala Chandra | Vita Data Science |
Kapila Patel | Syneos Health |
Krishna Varkur | PPD |
Laura Schafer | Bayer |
Project Members | Organisation |
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Lokesh Usher | Industry |
Michael Marroquin | PharmaStat |
Micky Salgao-Gomez | PharmaStat |
Mithun Ranga | Industry |
Pranab Mitra | Merck |
Raghava Regulla | Bayer |
Rajeswari Veeramallu | PPDI |
Randi McFarland | ICON |
Sameer Saxena | Bayer |
Sandy VanPelt Nguyen | Pfizer |
Sapan Patel | Merck |
Sarad Nepal | Merck |
Shitanshi Mehta | Industry |
Shyamprasad Samisetti | Merck |
Srinivas Kovvuri | Covance |
Sunil Gupta | Industry |
Susheel Arkala | MMS |
Swathi Kotla | Industry |
Tanvi Gupta | PPD |
Vanitha Dareedy | Gilead |
Vishnu Kollisetti | PPDI |
Yaling Teng | Amgen |
Yoshiko Kitagawa | ONO Pharma |