EU CT form - update 11 September 2018 Agenda item 4.0

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Presentation transcript:

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

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,

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

Use case review update

Use case review update

Use case review update

Use case review update

Use case review update

Use case review update

Use case review update

Use case review update

Use case review update

Use case review update

11 September 2018

Thank you for your attention 11 September 2018 Thank you for your attention Further information Please contact me on Noemie.Manent@ema.europa.eu European Medicines Agency 30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact Note: This slide is OPTIONAL. It uses the 'Closing slide' layout. Delete if not needed. Follow us on @EMA_News