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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, 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, 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.

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 LeadsEmail
Aatiya Zaidi, Gilead
Aatiya
aatiya.
Zaidi@gilead
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.

eu

global

Project Members


Status

Company

colour

Achim Klotz

Blue

Roche

title

Aiming YangMerckAjay GuptaPPDIAmy AdyanthayaBiogenAngelica HochJNJAnne LindbergRocheAnnette TravalentLillyArvind Sri Krishna ManiZiforndAudrey YuJNJBrian HarrisMedimmuneColleen RatliffeFDACristina Do CarmoNovartisCynthia StroupeUCBDiane WoldCDISCDorothy DlaminiBayerDoug WarfieldFDAElizabeth LangevinTakedaFarhan Hameed (CJ)PfizerGloria JonesITS JNJGrace FengBMSHans Peter - SchreiterEntimoHarsha AnantanardhanPfizerHelena SviglinFDAHimaja SurapaneniChilternIIse AugustynsJNJJack ZhangFDAJade ChenFDAJanet RoichAmgenJee Run LeeFDAJeffry FlorianFDAJoanne ZhouGSKJohannes UlanderS-CubedJohn BielinskiIndependentJoosep RaudsikStatfinnJulie MaynardJNJKajal TahilianiCytelKamiar Mike HamidiMerckKannan NagureddiAmgenKapila PatelInventivHealthKatherine XieAbbvieKathy KnucklesLillyKeith HibbettsLillyKelly MewesRocheKen StoltzfusAccentureKiran BondaInventiv HealthKiran Kumar KundarapuMerckKiranKumar PadhiarJNJKoichi YamaguchiLillyKristie KookenAchaogen

Current Status
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 1.027-Oct-2020
Best Practices for Submissions of Event Adjudication: Version 1.002-Dec-2019
Kristin C Kellypinnacle 21