Difference between revisions of "SDTM ADaM Implementation FAQ"

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| John Bielinski || Independent || Olga Vovk || NIH
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| Nancy Brucken ||Syneoshealth || Cynthia Stroupe ||  UCB
| Brian Harris || Medimmune || ||

Latest revision as of 06:28, 12 August 2019

Project Overview

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). 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:

  1. Collect frequently asked questions (FAQ) from the industry via a form on Wiki or PhUSE public events
  2. Assess the appropriateness of a question, develop & review response, collaborate with CDISC/FDA for clarity if required
  3. Publish the FAQ and responses on Wiki database for helpful implementation/strategy information

To see if your query has already been answered, view our FAQ page Project Team Curated Responses
If your query has not been addressed, then post your question using the following template Submit a Question

Project Progress

Currently this project has 2 sub teams focusing on drafting White Papers on ISS/ISE & Adjudication. Their findings will be discussed at our 2019 CSS event, 9-11 June.

The project has also submitted a Poster for the 2019 US Connect in Baltimore 24-27 Feb


Presentation to FDA
SDTM & ADaM Implementation FAQ
US CSS Monday 20th March 2017
US CSS Tuesday 21st March 2017

Project Leadership Team

Name Role Organisation Email
Bhavin Busa Project Co-Leader Vita Data Sciences bbusa@vitadatasciences.com
Amy Palmer Project Co-Leader CDISC APalmer@cdisc.org
Aatiya Zaidi Project Co-Leader Gilead Aatiya.Zaidi@gilead.com
Wendy Dobson PhUSE Project Manager PhUSE wendy@phuse.eu

Project Members

Name Company Name Company
Kiran Kumar Kundarapu Merck 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 Colleen Ratliffe FDA
Cristina Do Carmo Novartis Diane Wold CDISC
Doug Warfield FDA Dorothy Dlamini Bayer
Elizabeth Langevin Takeda Farhan Hameed (CJ) Pfizer
Gloria Jones ITS JNJ Helena Sviglin FDA
Hans Peter - Schreiter Entimo Harsha Anantanardhan Pfizer
Himaja Surapaneni Chiltern Jack Zhang FDA
Jade Chen FDA Jee Run Lee FDA
Jeffry Florian FDA Janet Roich Amgen
Joanne Zhou GSK Johannes Ulander S-Cubed
Raman Bassi Bayer Joosep Raudsik Statfinn
Julie Maynard JNJ Kajal Tahiliani Cytel
Kamiar Mike Hamidi Merck Kapila Patel InventivHealth
Kannan Nagureddi Amgen Katherine Xie Abbvie
Kathy Knuckles Lilly Keith Hibbetts Lilly
Kelly Mewes Roche Ken Stoltzfus Accenture
Kiran Bonda Inventiv Health Koichi Yamaguchi Lilly
Kristie Kooken Achaogen Kristin C Kelly pinnacle 21
Lakshmi Mallela ITS JNJ Laura Schonwalder Triangle Biostatistics
Liekie Gijsbers OCS Magdalena Wojciechowska Roche
Majdoub Haloui Merck Marjorie Nowak Novartis
Marguerite Kolb ITS JNJ Marleen Nijs ITS JNJ
Mathias Lebreton Novartis Natalia Jacquet Phastar
Nate Freimark The Griesser Group Naveed Khaja Independent
Peter Van Reusel CDISC Pritesh Solanki Merck
Ramachandran Radhakrishanan Merck Ruth Alonso Chiltern
Robert Stemplinger Industry Rui Li FDA
Sara Pauwels ITS JNJ Silke Hochstädter Abbie
Soumya Rajesh Inventivhealth Srinivasa Rao Mandava Industry
Sterling Hardy BMS Ta Jen Chen FDA
Tina Gursahani Industry Trevor Mankus Industry
Unnat Patel Pfizer Vanessa Sarrechia JNJ
Veena Nataraj Shire Veerie Coenen ITS JNJ
Vishnu Kollisetti PPDI Wioletta Schulze Grunenthal
Wei Lin FDA Weiya Zhang FDA
Yan Lei ITS JNJ Yoshiko Kitagawa Industry
Zhongwei Zhon Pfizer Tiffany Tian Industry
Laura Bellamy PPDI Sairam Gorthi JNJ
Shravan Kv datafoundry IIse Augustyns JNJ
KiranKumar Padhiar JNJ Venkata Peri JNJ
Audrey Yu JNJ Shravan KV Data Foundry
John Bielinski Independent Olga Vovk NIH
Nancy Brucken Syneoshealth Cynthia Stroupe UCB
Brian Harris Medimmune

Archived Materials

Archived Materials can be found by clicking this link