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Project Scope

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 (FAQs) from Industry. If you have a question for the team, email workinggroups@phuse.global.

  2. Assess the appropriateness of a question, develop & review a response, collaborate with CDISC/FDA for clarity if required.

  3. Publish the FAQ and responses on Advance Hub database for helpful implementation/strategy information.

Project LeadsEmail
Aatiya Zaidiaatiya.zaidi@gilead.com
Amy Palmer

apalmer@cdisc.org

Bhavin Busabbusa@vitadatasciences.com 
Katie Warrenkatie@phuse.global

CURRENT STATUS Q3/42021

  • This project initiated the first 'Expert Answers to Community Questions' Panel session which had members from FDA, CDISC and Industry present on Data Submissions. You can find the recording here and the blog here.
  • Conducted an Expert Answers to Community Questions Forum.
  • Published new FAQs and responses. 


Project MembersOrganisation
Aatiya Zaidi
Achim KlotzRoche
Aiming YangMerck
Ajay GuptaPPDI
Amy AdyanthayaBiogen
Angelica HochJanssen Research & Development
Anne LindbergRoche
Annette TravalentEli Lilly
Arvind Sri Krishna ManiZifornd
Athenkosi NkonyeniIndustry
Audrey YuJanssen Research & Development
Brian HarrisMedImmune
Colleen RatliffeFDA
Cristina Do CarmoNovartis
Cynthia StroupeUCB
Diane WoldCDISC
Dorothy DlaminiBayer
Doug WarfieldFDA
Elizabeth LangevinTakeda
Farhan Hameed (CJ)Pfizer
Gloria JonesJanssen Research & Development
Grace FengBMS
Hans Peter - SchreiterEntimo
Harsha AnantanardhanPfizer
Helena SviglinFDA
IIse AugustynsJanssen Research & Development
Jack ZhangFDA
Jade ChenFDA
Janet RoichAmgen
Jee Run LeeFDA
Jeffry FlorianFDA
Joanne ZhouGSK
Johannes UlanderS-cubed
John BielinskiIndustry 
Julie MaynardJanssen Research & Development
Kajal TahilianiCytel
Kamiar Mike HamidiMerck
Kannan NagureddiAmgen
Kapila PatelIQVIA
Katherine XieAbbVie
Kathy KnucklesEli Lilly
Keith HibbettsEli Lilly
Kelly MewesRoche
Ken StoltzfusAccenture
Kiran BondaSyneos Health
Kiran Kumar KundarapuMerck
KiranKumar Padhiar

Janssen Research & Development

Koichi YamaguchiEli Lilly
Huaifeng Wang Haisco
Inayath Ali Parexel
Maria Dalton Takeda
Project MembersOrganisation
Kristie KookenAchaogen
Kristin C KellyPinnacle 21
Lakshmi MallelaJanssen Research & Development
Laura BellamyPPD
Laura SchonwalderTriangle Biostatistics
Liekie GijsbersOCS Life Sciences
Magdalena WojciechowskaRoche
Majdoub HalouiMerck
Marguerite KolbJanssen Research & Development
Marleen NijsJanssen Research & Development
Mathias LebretonNovartis
Mehadjia MahboubSanofi
Nancy BruckenCSG
Natalia JacquetPHASTAR
Nate FreimarkThe Griesser Group
Naveed KhajaIndustry
Olga VovkNIH
Pritesh SolankiMerck
Ramachandran RadhakrishananMerck
Raman BassiBayer
Remesh KavicharlaCRC Pharma
Robert StemplingerIndustry
Rui LiFDA
Ruth AlonsoChiltern
Sairam GorthiJanssen Research & Development
Sameer SaxenaBayer
Shravan KvData Foundry
Silke HochstädterAbbVie
Soumya RajeshAmgen
Srinivasa Rao MandavaIndustry
Sterling HardyBristol Myers Squibb
Ta Jen ChenFDA
Tiffany TianIndustry
Tina GursahaniIndustry
Trevor MankusIndustry
Unnat PatelPfizer
Vanessa SarrechiaJanssen Research & Development
Veena NatarajShire
Veerie CoenenJanssen Research & Development
Venkata PeriJanssen Research & Development
Vishnu KollisettiPPDI
Wei LinFDA
Weiya ZhangFDA
Wioletta SchulzeGrünenthal
Yan LeiJanssen Research & Development
Yoshiko KitagawaIndustry
Zhongwei ZhonPfizer
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