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 | |
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Kiran Kundarapu | |
Satheesh Avvaru | |
Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
Objectives & Deliverables |
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colour | Blue |
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title | Current Status |
- 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.
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 NoticeTimelines |
Finalisation of full BDRG package (assessing/incorporating comments from public review) | Apr-2022 |
Full team including FDA limited review (CDER & CBER PHUSE BIMO team members) | Apr-2022 |
Finalisation of full BDRG package (incorporating any remaining comments from the full PHUSE BIMO team) | Apr-2022 |
Rollout: PHUSE US Connect | May-2022 |
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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 | IQVIA |
Krishna Varkur | PPD |
Laura Schafer | Bayer |
Project Members | Organisation |
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Kapil Arnand | Parexel |
Lokesh Usher | Industry |
Mathura Ramanathan | Labcorp |
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 | Labcorp |
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 |
Winkle Lu | Industry |