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Date

Tuesday  

Time9am-3pm (CET)
Sign-uphttps://web.cvent.com/event/c19f83a6-23c7-4d42-8115-4d286366f892/websitePage:645d57e4-75eb-4769-b2c0-f201a0bfc6ceThis event is now closed

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.

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Agenda

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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)
12:0035 mins
  • SoA 2
  • BCs Procedures & Conditions
  • Theory (10 mins)
  • Exercise (20 mins)
  • Q&A (5 mins)
12:3535 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

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Link to DDF Orientation page on the CDISC WIKI

Digital Data Flow (DDF) Team Home/Orientation (CDISC Wiki account required)

USDM v3.0

Pre-Reads (Materials to look at prior to the workshop if you wish to. NOT compulsory!)

At the time of the workshop this was version 3.0.

Web tools

Web Tools (no need to install - these will run from a web browser)

Workshop files

Files below referenced in the DDF workshop

#FileDownload Link
1

Excel file is the started XL file

EU_NCT04573309.xlsx
2

NCT04573309.pdf is the protocol

NCT04573309.pdf
3

SoA.pdf is the SoA extracted from the protocol and stiched together

SoA.pdf
4

Protocol.png is an infographic of where content goes in USDM

protocol.png
Full workshop example
Workshop slides

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