'Sdtm implementation' presentation slideshows

CDASH Initiative

CDASH Initiative. CDASH Project Description & Status. Rhonda Facile Project Leader, CDISC. CDASH Project Process. Outline Background and Charter CDISC COP 001 Project Organization Project Process SDTM Review of Progress Next Steps Activities & Project Notes Accomplishments to Date

725 views • 27 slides

Dianne Weatherall: 2013-04-11

An exploration of quality gaps in SDTM implementation activities and ideas on how to address these gaps through appropriate resourcing. Dianne Weatherall: 2013-04-11. GOAL. Adoption of CDISC standards has led to: new processes ( aCRF , metadata, programming) new responsibilities

378 views • 20 slides

Brian Mabe UCB Biosciences, Inc.

161 views • 16 slides

Berlin, September 25, 2007

Establishment of German CDISC User Group: Discussion templates. Berlin, September 25, 2007. Proposed agenda structure: Welcome CDISC Case studies CDISC News CDISC Events CDISC User Group Discussions CDISC User Group Workstreams update Q&A Proposed meeting duration: 4-6 hours.

219 views • 6 slides

CDER Common Data Standards Issues Document

CDER Common Data Standards Issues Document. Motivation CDISC submissions received varied more than expected Contents Current FDA‘s preferences/recommendation for SDTM/ADaM More guidance on SDTM implementation than ADaM DIA Webinar with CDER And CBER representatives Mainly Q&A

201 views • 4 slides