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Meeting Agenda (KLick to download PDF version)

View file
name30th German CDISC UN Agenda

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20230314.pdf
height

...

150


Date:                    14 March 2023

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65843 Sulzbach(Taunus) 

Kontakt: katrin.besch@mainanalytics.debesch[at]mainanalytics.de

                                                                                                                                                                                                                                                                          

Time               

Topic                                                                                                                               

Who                                                              

Time

Topic

Who

9:30

Registration

All

10:00

Welcome and introduction to

Kantar Health

tbd

Kurt Hellstern

mainanalytics

Beate Hientzsch, Markus Stoll

10:10

Focus

  • Annotated CRF – Update to he Sub-Team Achievements
  • I did it my way… - examples, how it has been done so far.

Markus Stoll, Torsten Petsching, Stefan Bordasch

Kurt Hellstern, tbd

11:10

Break

11:30

Annotated CRF, continued, if necessary

Pointcross evalidator Testbericht (Kerstin)

Conformance guide update (Marion)

Session

    ·  FDA CDISC Standards “requirements” in 2023                       

       o   Define-XML v2.1 - What’s New

       o   Technical Conformance Guide – Updates?                    

       o   SDTM-IG v3.3 / v3.4 - What’s New                                 

              *  SV, LB/MB/IS, GF

              *  PR, AE CE, EG, EC, VS, FT, FA, TS, QS, SC, SE
                  plus Model SDTM v1.8 to v2.0



Steffen Müller

Jens Fooken


Dagmar Kottig-Roth

Judith Köppert

11:15

Break


11:30

Continue CDISC Standards discussion…


    ·  FDA vs PMDA - Discussion


    ·  CDISC Outlook 2023 - Expected updates/News

       o  ADaM MSG insights

       o  DM / DC

All


Monika Kawohl + All



Nicola Tambascia

Judith Köppert

All

Kerstin Kaatz,

Marion Friebel

12:30

Lunch and Get-Together


13:30

ADaM IG 1.2

Pinnacle und ADaM

Define 2.1 und ADaM





14:15



14:30

CDISC COSA Initiative

    ·  COSA Introduction

       o   CDISC Hackathon: "admiral" - Insights

       o   CDISC Rules Engine (CORE)


DEUN UG TOI-Initiative - Tools of Interest Presentations

    ·  Status + Outlook 2023


CDISC Library for Dummies – First Steps

    ·  Data Standard Browser

    ·  API Remote Access – How To


Markus Stoll

Andrea Weber

Stefanie Sturm


Markus Stoll




Christina Paul (verschoben)

Jozef Aerts

Judith Köppert

Hans-Peter Schnitzer

Monika Kawohl

15:00

Break


15:30

How to access the CDISC Library or CDISC Library for Dummies

Presentation: CDISC_Library_Präsentation_Jozef_GSUG_2020-06-19.pdf

Link 2 Library Documentation:

https://www.cdisc.org/cdisc‐library/api‐documentation

CDISC - Hidden Details

    ·  COVID-TAUG 

       o   SDTM

       o   ADaM Component

    ·  CT Relationships

    ·   Dictionaries in define.xml

       o   Define CT

    ·   LB domain History

    ·  Submission of Programs to authorities

Monika Kawohl and all







Dagmar Kottig-Roth

Nicola Tambascia

16.00

CDISC User Group Discussion

    ·  Poll - Usergroup Steering Committee

    ·  Topics of interest

    · 

Jozef Aerts

16.00

Lab Units Representation Team Update

Èanna Kiely

16.30

CDISC User Group Discussion

  • Feedback: How is the GUN Wiki doing?
  • Topics of interest

    • Next meeting / Meeting / Closing remarks

    Markus Stoll

    ...

    and all


    17:

    00

    15

    Meeting end




    Summary:



    other Meeting detailsPresentations...

    Anfahrt:

    Sag Google Maps oder Deinem Navi Landsberger Strasse 284, 80687 München

     30th German CDISC UN Agenda 20230203.pdf

    Hotelliste (Empfehlungen, keine Kontingente)

    https://www.wyndhamhotels.com/de-de/super-8/munich-germany/super-8-munich-city- west/overview?CID=LC:SE::GGL:RIO:National:48361&iata=00093796

    (Hotel ist neben Kantar, Zimmer völlig ok, sauber, modern aber eben eher klein aber auch relativ günstig, Achtung, immer schnell ausgebucht!)

    https://www.ihg.com/holidayinnexpress/hotels/us/en/munich/mucwt/hoteldetail?cm_mm c=GoogleMaps-_-EX-_-DE-_-MUCWT

    (Hotel an der Friedenheimer Brücke, S-Bahn Hirschgarten, von dort dann 1 Station hierher)

    https://www.motel-one.com/de/hotels/muenchen/hotel-muenchen-westend/

    (Hotel ist 5 Minuten zu Fuß von der Donnersberger Brücke / S-Bahn Station Donnersberger Brücke, 2 Stationen bis zu Kantar)

    https://www.motel-one.com/de/hotels/muenchen/hotel-muenchen-westend/

    (Hotel ist auch direkt an der Donnersberger Brücke / S-Bahn Station Donnersberger Brücke, 2 Stationen bis zu Kantar)

      

    Vorabend Essen: ab 18.30 im Restaurant Augustiner Bräustuben

    20230314_GCUG_01-01_Definev2-1-news_SMueller.pdf

    20230314_GCUG_01-02_FDA-TCG-v5-0_JFooken.pdf

    20230314_GCUG_01-03_Whats_New_IGv3.4_DKottig-Roth.pdf

    20230314_GCUG_01-04_SDTM_IG_3_4_WhatsNew_JKoeppert.pdf

    20230314_GCUG_02-01_CDISC-Requirements-FDA-PMDA_MKawohl.pdf

    20230314_GCUG_02-03_Multiple enrollments_JKoeppert.pdf

    20230314_GCUG_03-02_CDISC Hackathon-Admiral-Insights_AWeber_20230315_updt.pdf

    20230314_GCUG_03-03_CORE_SSturm.pdf

    20230314_GCUG_03-06_CDISC_Library_API_JAerts.pdf

    20230314_GCUG_04-03_LB_History_DKottig-Roth.pdf

    20230314_GCUG_04-04_Submission of Programs to authorities_NTambascia.pdfhttp://www.braeustuben.de/ (Augustiner, Landsberger Straße)