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Scope China FDA email  the Wiki

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,

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:

  1. Collect frequently asked questions (FAQs) from Industry. If you have a question for the team,

  1. 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

  1. Advance Hub database for helpful implementation/strategy information.



Project LeadsEmail
Aatiya Zaidi, Gileadaatiya.zaidi@gilead.com
Amy Palmer
apalmer@cdisc.org

TBC

Bhavin Busa, Clymb Clinical
bbusa@vitadatasciences
bhavin@clymbclinical.com
 Wendy Dobson (
Nicola Newton, PHUSE Project
Manager)
Assistant
wendy@phuse

nicky@phuse.global


Status
colourBlue
titleCurrent Status

Q42020Team continue to provide responses to questions received. They are also looking at how they can evolve Resources

Q2 2024

  • Published a new FAQ.
  • Continuing to work on FAQs that have been sent in.



Objectives & Deliverables Timelines 

Publish responses to questions received under: 

Ongoing 


Published DeliverablesDate
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-2019Project MembersCompanyAchim KlotzRocheAiming YangMerckAjay GuptaPPDIAmy AdyanthayaBiogenAngelica HochJanssen Research & DevelopmentAnne LindbergRocheAnnette TravalentEli LillyArvind Sri Krishna ManiZiforndAthenkosi NkonyeniIndustryAudrey YuJanssen Research & DevelopmentBrian HarrisMedimmuneColleen RatliffeFDACristina Do CarmoNovartisCynthia StroupeUCBDiane WoldCDISCDorothy DlaminiBayerDoug WarfieldFDAElizabeth LangevinTakedaFarhan Hameed (CJ)PfizerGloria JonesJanssen Research & DevelopmentGrace FengBMSHans Peter - SchreiterEntimoHarsha AnantanardhanPfizerHelena SviglinFDAHimaja SurapaneniChilternIIse AugustynsJanssen Research & DevelopmentJack ZhangFDAJade ChenFDAJanet RoichAmgenJee Run LeeFDAJeffry FlorianFDAJoanne ZhouGSKJohannes UlanderS-cubedJohn BielinskiIndustry Joosep RaudsikStatfinnJulie MaynardJanssen Research & DevelopmentKajal TahilianiCytelKamiar Mike HamidiMerckKannan NagureddiAmgenKapila PatelSyneos HealthKatherine XieAbbVieKathy KnucklesEli LillyKeith HibbettsEli LillyKelly MewesRocheKen StoltzfusAccentureKiran BondaSyneos HealthKiran Kumar KundarapuMerckKiranKumar Padhiar

Janssen Research & Development

Koichi YamaguchiEli LillyKristie KookenAchaogenKristin C KellyPinnacle 21Project MembersCompanyLakshmi MallelaJanssen Research & DevelopmentLaura BellamyPPDILaura SchonwalderTriangle BiostatisticsLiekie GijsbersOCS Life SciencesMagdalena WojciechowskaRocheMajdoub HalouiMerckMarguerite KolbJanssen Research & DevelopmentMarjorie NowakNovartisMarleen NijsJanssen Research & DevelopmentMathias LebretonNovartisMéhadjia MahboubSanofiNancy BruckenCSGNatalia JacquetPHASTARNate FreimarkThe Griesser GroupNaveed KhajaIndustryOlga VovkNIHPritesh SolankiMerckRamachandran RadhakrishananMerckRaman BassiBayerRemesh KavicharlaCRC PharmaRobert StemplingerIndustryRui LiFDARuth AlonsoChilternSairam GorthiJanssen Research & DevelopmentSameer SaxenaBayerShravan KvData FoundrySilke HochstädterAbbieSoumya RajeshAmgenSrinivasa Rao MandavaIndustrySterling HardyBMSTa Jen ChenFDATiffany TianIndustryTina GursahaniIndustryTrevor MankusIndustryUnnat PatelPfizerVanessa SarrechiaJanssen Research & DevelopmentVeena NatarajShireVeerie CoenenJanssen Research & DevelopmentVenkata PeriJanssen Research & DevelopmentVishnu KollisettiPPDIWei LinFDAWeiya ZhangFDAWioletta SchulzeGrünenthalYan LeiJanssen Research & DevelopmentYoshiko KitagawaIndustry
02-Dec-2019
Zhongwei ZhonPfizer