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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Kiran Kundarapu |
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Satheesh Avvaru |
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| Project Members | Company |
|---|---|
| Abhilash Vasu Chimbirithy | Merck |
| Adie Bonwick | GSK |
| Anand Jayaraman | Merck |
| Anita Baniya | PPDI |
| Aron Anton | PPDI |
| Aurora Liao | Industry |
| Carey Smoak | S-Cubed |
| Charanjit Kahlon | Softworld Inc |
| Ellen Asam | Merck |
| Ghanshyam Jangid | Merck |
| Hanne Ellehoj | Lundbeck |
| Imran Syed | Bayer |
| James Gaiser | Prometrika |
| Janet Low | Merck |
| Jane Lozano | Lilly |
| Jian Huang | Celgene |
| Kala Chandra | VitaDataScience |
| Kapila Patel | Syneoshealth |
| Krishna Varkur | PPD |
| Laura Schafer | Bayer |
| Lokesh Usher | Industry |
| Project Members | Company |
|---|---|
| Michael Marroquin | Pharmastat |
| Micky Salgao-Gomez | Pharmastat |
| Mithun Ranga | Industry |
| Pranab Mitra | Merck |
| Raghava Regulla | Bayer |
| Rajeswari Veeramallu | PPDI |
| Randi McFarland | IconPLC |
| Sameer Saxena | Bayer |
| Sandy VanPelt | Industry |
| Sapan Patel | Merck |
| Sarad Nepal | Merck |
| Sharayu Nadkarni | Pfizer |
| Shitanshi Mehta | Industry |
| Shyamprasad Samisetti | Merck |
| Srinivas Kovvuri | Covance |
| Sunil Gupta | Industry |
| Susheel Arkala | MMS Holdings |
| Swathi Kotla | Industry |
| Tanvi Gupta | PPD |
| Vanitha Dareedy | Gilead |
| Vishnu Kollisetti | PPD |
| Yaling Teng | Amgen |