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Project | ScopeScope |
The Standards Implementation Nuances sessions at the March North America 2016 CSS and June EU 2016 CSS surfaced various common challenges amongst SDTM and ADaM implementers and consumers. In addition, there were many questions discussed related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, | China FDA NMPA). It became very clear that the Industry is in need of a forum and subsequent knowledge-base (FAQ) to address these challenges. This project team was formed in June 2016 to collaborate with Subject Matter Experts (SMEs) from the industry, CDISC, and the FDA. The goal of this project team is to: Collect frequently asked questions (FAQs) from Industry. If you have a question for the team,
| email email workinggroups@phuse.global. Assess the appropriateness of a question, develop & review a response, collaborate with CDISC/FDA for clarity if required. Publish the FAQ and responses on
| the Wiki Advance Hub database for helpful implementation/strategy information.
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apalmer@cdisc.orgTBC |
Bhavin Busa, Clymb Clinical |
bbusa@vitadatasciences Wendy Dobson ( |
Nicola Newton, PHUSE Project |
Manager)wendy@phuse
Status |
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colour | Blue |
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title | Current Status |
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Q42020ResourcesTeam continue to provide responses to questions received. They are also looking at how they can evolve |
- Continuing to work on FAQs that have been sent in.
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Objectives & Deliverables | Timelines |
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Publish responses to questions received under: | Ongoing |
, , 2-Dec-2019Project Members | Company |
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Achim Klotz | Roche |
Aiming Yang | Merck |
Ajay Gupta | PPDI |
Amy Adyanthaya | Biogen |
Angelica Hoch | Janssen Research & Development |
Anne Lindberg | Roche |
Annette Travalent | Eli Lilly |
Arvind Sri Krishna Mani | Zifornd |
Audrey Yu | Janssen Research & Development |
Brian Harris | Medimmune |
Colleen Ratliffe | FDA |
Cristina Do Carmo | Novartis |
Cynthia Stroupe | UCB |
Diane Wold | CDISC |
Dorothy Dlamini | Bayer |
Doug Warfield | FDA |
Elizabeth Langevin | Takeda |
Farhan Hameed (CJ) | Pfizer |
Gloria Jones | Janssen Research & Development |
Grace Feng | BMS |
Hans Peter - Schreiter | Entimo |
Harsha Anantanardhan | Pfizer |
Helena Sviglin | FDA |
Himaja Surapaneni | Chiltern |
IIse Augustyns | Janssen Research & Development |
Jack Zhang | FDA |
Jade Chen | FDA |
Janet Roich | Amgen |
Jee Run Lee | FDA |
Jeffry Florian | FDA |
Joanne Zhou | GSK |
Johannes Ulander | S-cubed |
John Bielinski | Industry |
Joosep Raudsik | Statfinn |
Julie Maynard | Janssen Research & Development |
Kajal Tahiliani | Cytel |
Kamiar Mike Hamidi | Merck |
Kannan Nagureddi | Amgen |
Kapila Patel | Syneos Health |
Katherine Xie | AbbVie |
Kathy Knuckles | Eli Lilly |
Keith Hibbetts | Eli Lilly |
Kelly Mewes | Roche |
Ken Stoltzfus | Accenture |
Kiran Bonda | Syneos Health |
Kiran Kumar Kundarapu | Merck |
KiranKumar Padhiar | Janssen Research & Development |
Koichi Yamaguchi | Eli Lilly |
Kristie Kooken | Achaogen |
Kristin C Kelly | Pinnacle 21 |
Project Members | Company |
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Lakshmi Mallela | Janssen Research & Development |
Laura Bellamy | PPDI |
Laura Schonwalder | Triangle Biostatistics |
Liekie Gijsbers | OCS Life Sciences |
Magdalena Wojciechowska | Roche |
Majdoub Haloui | Merck |
Marguerite Kolb | Janssen Research & Development |
Marjorie Nowak | Novartis |
Marleen Nijs | Janssen Research & Development |
Mathias Lebreton | Novartis |
Méhadjia Mahboub | Sanofi |
Nancy Brucken | CSG |
Natalia Jacquet | PHASTAR |
Nate Freimark | The Griesser Group |
Naveed Khaja | Industry |
Olga Vovk | NIH |
Pritesh Solanki | Merck |
Ramachandran Radhakrishanan | Merck |
Raman Bassi | Bayer |
Remesh Kavicharla | CRC Pharma |
Robert Stemplinger | Industry |
Rui Li | FDA |
Ruth Alonso | Chiltern |
Sairam Gorthi | Janssen Research & Development |
Sameer Saxena | Bayer |
Shravan Kv | Data Foundry |
Silke Hochstädter | Abbie |
Soumya Rajesh | Amgen |
Srinivasa Rao Mandava | Industry |
Sterling Hardy | BMS |
Ta Jen Chen | FDA |
Tiffany Tian | Industry |
Tina Gursahani | Industry |
Trevor Mankus | Industry |
Unnat Patel | Pfizer |
Vanessa Sarrechia | Janssen Research & Development |
Veena Nataraj | Shire |
Veerie Coenen | Janssen Research & Development |
Venkata Peri | Janssen Research & Development |
Vishnu Kollisetti | PPDI |
Wei Lin | FDA |
Weiya Zhang | FDA |
Wioletta Schulze | Grünenthal |
Yan Lei | Janssen Research & Development |
Yoshiko Kitagawa | Industry |
Zhongwei Zhon | Pfizer