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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.

Agenda


TimeAgenda ItemNote
08-00:09:0060 minsWelcome Coffee Zoo Foyer (1F)
09:0015 MinsIntroduction
  • Introductions
  • DDF Introduction
  • Aims of the Workshop

09:15

35 mins
  • Overall framework
  • Structured and Unstructured Content
  • Study, Protocol
  • Titles
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (5 mins)
09:5040 mins
  • Inclusion & Exclusion
  • Objectives
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (10 mins)
10:30-10:4515 minsBreakZoo Foyer (1F)
10:4525 mins
  • Population
  • Cohorts
  • Theory (5 mins)
  • Exercise (15 mins)
  • Q&A (5 mins)
11:2040 mins
  • SoA 1
  • Timelines & Timing
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (10 mins)
13:0035 mins
  • SoA 2
  • BCs Procedures & Conditions
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (5 mins)
13:3535 mins
  • Amendments
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (5 mins)
13:00-14:0060 minsLunchBon Dia Restaurant (2F)
14:1045 mins
  • Narrative Content
  • Protocol Document
  • M11
  • Theory (10 mins)
  • Exercise (25 mins)
  • Q&A (10 mins)
14:4515 Mins
  • Wrap-up
  • Wrap up of the workshop
  • Feedback from the group
  • Follow-on actions
15:00-15:3030 minsCoffeeZoo Foyer (1F)

Participant information

Include Page
TEAMDDF:Links for public wiki page
TEAMDDF:Links for public wiki page

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