Standard implementation nuances exist across the multiple available versions of SDTM and ADaM. The project will establish a framework for the collection, compilation, assessment, response to, and publishing of common SDTM and ADaM implementation challenges/nuances. This is important for sponsors who are still transitioning to newer versions of standards (eg SDTM), as well as the vast majority who have to govern multiple versions, even for a single product or application. This is a join project between PHUSE and CDISC.
Project ScopeThe 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). 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:
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Project Leads | |
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Aatiya Zaidi | Aatiya.Zaidi@gilead.com |
Amy Palmer | |
Bhavin Busa | bbusa@vitadatasciences.com |
Wendy Dobson (PHUSE Project Manager) |
Resources |
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Integration Strategies in Support of ISS/ISE Submissions: Version 1.0, 27-Oct-2020 Best Practices for Submissions of Event Adjudication: Version 1.0, 2-Dec-2019 |
Project Members | Company |
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Achim Klotz | Roche |
Aiming Yang | Merck |
Ajay Gupta | PPDI |
Amy Adyanthaya | Biogen |
Angelica Hoch | JNJ |
Anne Lindberg | Roche |
Annette Travalent | Lilly |
Arvind Sri Krishna Mani | Zifornd |
Audrey Yu | JNJ |
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 | ITS JNJ |
Grace Feng | BMS |
Hans Peter - Schreiter | Entimo |
Harsha Anantanardhan | Pfizer |
Helena Sviglin | FDA |
Himaja Surapaneni | Chiltern |
IIse Augustyns | JNJ |
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 | Independent |
Joosep Raudsik | Statfinn |
Julie Maynard | JNJ |
Kajal Tahiliani | Cytel |
Kamiar Mike Hamidi | Merck |
Kannan Nagureddi | Amgen |
Kapila Patel | InventivHealth |
Katherine Xie | Abbvie |
Kathy Knuckles | Lilly |
Keith Hibbetts | Lilly |
Kelly Mewes | Roche |
Ken Stoltzfus | Accenture |
Kiran Bonda | Inventiv Health |
Kiran Kumar Kundarapu | Merck |
KiranKumar Padhiar | JNJ |
Koichi Yamaguchi | Lilly |
Kristie Kooken | Achaogen |
Kristin C Kelly | pinnacle 21 |
Project Members | Company |
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Lakshmi Mallela | ITS JNJ |
Laura Bellamy | PPDI |
Laura Schonwalder | Triangle Biostatistics |
Liekie Gijsbers | OCS |
Magdalena Wojciechowska | Roche |
Majdoub Haloui | Merck |
Marguerite Kolb | ITS JNJ |
Marjorie Nowak | Novartis |
Marleen Nijs | ITS JNJ |
Mathias Lebreton | Novartis |
Nancy Brucken | CSG |
Natalia Jacquet | Phastar |
Nate Freimark | The Griesser Group |
Naveed Khaja | Independent |
Olga Vovk | NIH |
Peter Van Reusel | CDISC |
Pritesh Solanki | Merck |
Rabia Ahmad | GSK |
Ramachandran Radhakrishanan | Merck |
Raman Bassi | Bayer |
Remesh Kavicharla | CRC Pharma |
Robert Stemplinger | Industry |
Rui Li | FDA |
Ruth Alonso | Chiltern |
Sairam Gorthi | JNJ |
Sameer Saxena | Bayer |
Shravan Kv | datafoundry |
Shravan KV | Data Foundry |
Silke Hochstädter | Abbie |
Soumya Rajesh | Amgen |
Srinivasa Pillarisetty | Astrazeneca |
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 | JNJ |
Veena Nataraj | Shire |
Veerie Coenen | ITS JNJ |
Venkata Peri | JNJ |
Vishnu Kollisetti | PPDI |
Wei Lin | FDA |
Weiya Zhang | FDA |
Wioletta Schulze | Grunenthal |
Yan Lei | ITS JNJ |
Yoshiko Kitagawa | Industry |
Zhongwei Zhon | Pfizer |