Slide 1Monika Kawohl Senior Statistical Programmer Accovion GmbH, Marburg, Germany CDISC based eSubmission Key Points of the CDISC SDTM/ADaM Pilot Slide 2 CDISC German UG…

Slide 1Elke Sennewald, 22 September 2011 Trial Design Introduction Slide 2 Information about study design – No subject data Describe the overall trial design and plan via…

Slide 1Restricted © Business & Decision Life Sciences 2014 All rights reserved. Business & Decision Life Sciences CD03: What’s new in ADaM Gavin Winpenny 13 October…

Slide 1 ADaM Standards Wouter van Wyk Slide 2 Why ADaM –SDTM purpose is to provide collected data Not designed for ease of analysis –ADaM purpose is to provide data that…

Slide 1 Trial Design in the CDISC World Albert Chau 26 July 2011 1 Slide 2 Agenda How to construct Trial Design datasets o Relationships with other SDTM domains Challenges…

Slide 1 Business & Decision Life Sciences CD03: What’s new in ADaM Gavin Winpenny 13 October 2014 Restricted © Business & Decision Life Sciences 2014 All rights…

Slide 1 Business & Decision Life Sciences CD03: What’s new in ADaM Gavin Winpenny 13 October 2014 Restricted © Business & Decision Life Sciences 2014 All rights…

with OpenCDISC Validator * What is * OpenCDISC Validator Open source project Freely Available Commercial-quality Facilitate compliance with CDISC standards SDTM ADaM ODM…

Considerations for an ADaM Submission Jack Shostak Chris Holland Considerations for an ADaM Submission A collection of ADaM considerations: Initial Dataset Size Define.xml…

Cathy Barrows, Ph.D. GlaxoSmithKline Co-Leader of CDISC Pilot Project CDISC ADaM Team An Update on the CDISC SDTM/ADaM Pilot Project FDA/Industry Statistics Workshop - 29…