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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.
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| 15 Mins | Introduction | - 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 mins | Break |
| | 25 mins | | - Theory (5 mins)
- Exercise (15 mins)
- Q&A (5 mins)
| | 40 mins | | - 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 | | - Theory (10 mins)
- Exercise (20 mins)
- Q&A (5 mins)
| | 60 mins | Lunch |
| | 45 mins | - Narrative Content
- Protocol Document
- M11
| - Theory (10 mins)
- Exercise (25 mins)
- Q&A (10 mins)
| | 15 Mins | | - Wrap up of the workshop
- Feedback from the group
- Follow-on actions
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| TEAMDDF:Links for public wiki page |
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| TEAMDDF:Links for public wiki page |
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