SDTM ADaM Implementation FAQ

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Contents

  1. Project Overview
  2. Project Updates
  3. Project Deliverables
  4. Project Leadership Team
  5. Project Members
  6. Objectives and Timelines
  7. Project Content and Activities
  8. Meeting Minutes
  9. Have a query on SDTM/ADaM - Use this link to submit your questions.
  10. FAQ Team Responses

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


FAQ Process Diagram

Project Updates

August 2017
The SDTM/ADaM project has been fortunate enough to host 2 face to face meetings this year. CSS Siliver Spring back in March and EU CSS London in June. Together with the face to face encounters and the sub-team meetings, a team response has been compiled to many questions received which has now been published on the wiki page, PhUSE media outlets, Mailshots etc.

This has been an extremely productive year for this project and they are now focusing on bringing the last remaining questions together with any new one received under 1 project team call on a bi-weekly basis with a view to publishing any new responses when appropriate.

November 2016
This project has now split into 5 sub-teams to focus on the following:


CSS 2017 Event

CSS 2017 Presentation Slide Decks

Monday 20th March
Tuesday 21st March

Project Leadership Team

Name Role Organisation Email
Bhavin Busa Project Leader Vita Data Sciences bbusa(at)vitadatasciences.com

(mailto:bbusa@vitadatasciences.com)

Mat Bryant Project Leader InVentiv Health Clinical mathew.bryant(at)inventivhealth.com

(mailto:mathew.bryant@inventivhealth.com)

Wendy Dobson PhUSE Project Co-ordinator PhUSE wendy(at)phuse.eu

(mailto:wendy@phuse.eu)

Project Members

Name Organisation
Colleen Ratliffe FDA
Crystal Allard FDA
Doug Warfield FDA
Helena Sviglin FDA
Jack Zhang FDA
Jade Chen FDA
Jee Run Lee FDA
Rui Li FDA
Ta Jen Chen FDA
Wei Lin FDA
Weiya Zhang FDA
Aatiya Zaidi Gilead
Achim Klotz Roche
Aiming Yang Merck
Ajay Gupta PPDI
Amy Adyanthaya Biogen
Anne Lindberg Roche
Annette Travalent Lilly
Arvind Sri Krishna Mani Zifornd
Barrie Nelson CDISC
Cristina Do Carmo Novartis
Diane Wold CDISC
Dorothy Dlamini Bayer
Elizabeth Langevin Takeda
Elsa Lozachmeur Novartis
Eric Qi Merck
Gloria Jones ITS JNJ
Hans Peter - Schreiter Entimo
Harsha Anantanardhan Pfizer
Himaja Surapaneni Chiltern
Janet Roich Amgen
Joanne Zhou GSK
Johannes Ulander S-Cubed
John Troxell Accenture
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
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
Pritesh Solanki Merck
Ruth Alonso Chiltern
Robert Stemplinger Industry
Sara Pauwels ITS JNJ
Silke Hochstädter Abbie
Soumya Rajesh Inventivhealth
Srinivasa Rao Mandava Industry
Sterling Hardy BMS
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
Yan Lei ITS JNJ
Yoshiko Kitagawa Industry
Zhongwei Zhon Pfizer
Ramachandran Radhakrishanan Merck

Objectives and Timelines

Objectives Timelines
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Project Content and Activities

Meeting Minutes

Webinar Presentations