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This will be the first public, in-depth, workshop on the Unified Study Definitions Model (USDM). The workshop will take a deep dive into all aspects of the model and how study protocols and designs can be represented using the USDM. 

The day will be organised as a series of focused sessions, with each session covering the theory on an individual aspect of the model (e.g., timing, biomedical concepts, interventions, versioning, links with other standards such as SDTM, ICH M11, Trial Registries), combined with hands-on exercises and discussion.

15 MinsIntroduction
  • Introductions
  • DDF Introduction
  • Aims of the Workshop
35 mins
  • Overall framework
  • Structured and Unstructured Content
  • Study, Protocol
  • Titles
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (5 mins)
40 mins
  • Inclusion & Exclusion
  • Objectives
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (10 mins)
15 minsBreak
25 mins
  • Population
  • Cohorts
  • Theory (5 mins)
  • Exercise (15 mins)
  • Q&A (5 mins)
40 mins
  • SoA 1
  • Timelines & Timing
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (10 mins)
35 mins
  • SoA 2
  • BCs Procedures & Conditions
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (5 mins)
35 mins
  • Amendments
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (5 mins)
60 minsLunch
45 mins
  • Narrative Content
  • Protocol Document
  • M11
  • Theory (10 mins)
  • Exercise (25 mins)
  • Q&A (10 mins)
15 Mins
  • Wrap-up
  • Wrap up of the workshop
  • Feedback from the group
  • Follow-on actions




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