Details zu Anfahrt unter der Agenda im Dokument: 27th German CDISC UN Agenda_2018-08-17.pdf
Details zum Meeting am Vorabend und Unterkunft: CDISC Ludwigshafen Hotelauswahl und Vorabend.pdf
Presentations:
27th DACH CDISC UN Meeting Presentations.zip
Agenda - 27th German CDISC User Network Meeting
(Version 2018-08-17)
Date: | 25. September 2018 | ||||
Location: | AbbVie Deutschland Gmbh & Co. KG Knollstrasse 50 67061 Ludwigshafen Bau 71 / Raum 301 | Kontakt: Anja Kreis Admin: Martina Berroth | |||
Time | Topic | Who | |||
9:30 | Registration | All | |||
10:00 | Welcome and introduction to AbbVie | Anja Kreis Kurt Hellstern | |||
10:10 10:40 | ISS – Integrated Analysis (integration where, how – experiences gained within a project) ISS – Metadata Handling in Define.xml | Petra Rein Judith Köppert | |||
11:10 | Break | ||||
11:30 | Discussion: Define.xml Process | Sabine Erbslöh, Susanne Bracht | |||
12:30 | Lunch and Get-Together | ||||
13:30 14:15 | Use of MDR/SHARE (set-up, integration with SHARE, how is it used, benefits, user feedback) An update on CDISC SHARE and how to use it | Michael Walter, Anja Kreis Frederick Malfait | |||
15:00 | Break | ||||
15:30 | Update to the FDA Technical Conformance Guide Discussion: Collection of Protocol Deviations (eCRF, external File, Derived) which deviations belong where (SDTM/ADaM) Converting original results using UCUM webservices Other topics to come along | Marion Friebel Dennis May Nicola Tambascia All | |||
16:15 | CDISC User Group Discussion • Annotated CRF Working Group update • Going Live with the new GUN Wiki • Break-out sessions to be planned for the next Meeting? • CDISC News / Regulatory Updates • Topics of interest • Next meeting / Meeting / Closing remarks | All Markus Stoll Markus Stoll | |||
17:00 | Meeting end | ||||