1. EU CT form - update 11 September 2018 Agenda item 4.0
Presented by Noemi Manent on DD MONTH YYYY
Compliance and Inspection department

2. Structured fields attached to use cases
SUC 1001: create new initial application
EU CT number
SUC 1005 populate country-dependent CT application information
MSC number of subjects
Site information
SUC 1009 Complete product details
Information on the product
The user will also be given the ability to define the IMP in terms of active substance or ATC code
SUC 1008 Complete trial details
Information on study identifiers, Scientific advice and PIP, Associated trials, Medical condition, objectives, inclusion/exclusion criteria, age rage, population, study design,

3. Feedback Feedback was provided on the structured data
during sub group teleconferences and offline reviews
by the MS
by CTFG

4. Use case review update

5. Use case review update

6. Use case review update

7. Use case review update

8. Use case review update

9. Use case review update

10. Use case review update

11. Use case review update

12. Use case review update

13. Use case review update

14. 11 September 2018

15. Thank you for your attention
11 September 2018
Thank you for your attention
Further information
Please contact me on
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0) Facsimile +44 (0)
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