Transcript Training session for Stakeholders CT results EudraCT V10

Training session for Stakeholders
• Clinical Trial Results in EudraCT V10
Presented by: Noemi Manent
Compliance and Inspection Service
An agency of the European Union
Agenda
 Purpose
 Legal basis requirements
 Clinical Trial Results in EudraCT V10
 Q&A
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Legal basis requirements
 Press release issued on 19 June 2014, the official date of the
end of the programming of EudraCT has been announced 21
July 2014 . The posting of summaries of clinical study results
in the European Clinical Trials Database (EudraCT) becomes
mandatory for Sponsors as of 21 July 2014.
 This date corresponds to the finalisation of the programming of
the database as referred to in a European Commission
guideline on results related information (2012/C 302/03).
Press release:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/06/new
s_detail_002127.jsp&mid=WC0b01ac058004d5c1
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Training session - CT Results in EudraCT V10
 Few examples are already available in the public domain:
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
structured data set

attachment
Results in EudraCT V10
 Results are provided for the trial and not per CTA
 There are three status for results in EudraCT
 draft (the user is preparing the results in the system)
 posted (the user has satisfactorily validated the results and agreed
with the T&C for publication)
 finalised (the results are final and can be viewed on the EU CTR if
the protocol related records are published)
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Results in EudraCT V10
 draft (the user is preparing the results in the system)

preliminary and can change at any time.
 posted (the user has satisfactorily validated the results and
agreed with the T&C for publication)
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
The data / document format have been validated against the
system validation rules established and available on the EudraCT
website

The sponsor has agreed with the T&C for publication

There is a delay of 14 days between the posting date and the
publication date

During this period, the sponsor has the possibility to retract the
publication. If so, the results status returns to “draft”.
Results in EudraCT V10
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Results in EudraCT V10
 Finalised:
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
the results are final and can be viewed on the EU CTR if the
protocol related records are published.

Cases when the results are not published:

Phase 1 trials conducted in adults (not part of a PIP)

If all CTAs related to the trial have the CA decision/IEC opinion missing
Results in EudraCT V10
The results can be presented as follows:
 With an attachment only (PDF…): option reserved for old trials
(that do not included paediatrics population) that have ended
in the past on or before 21 July 2013
 with structured data (with or without attachment):
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
trials that have ended after 21 July 2013 (less than a year before
the finalisation of EudraCT)

Trials that include paediatric population (even if they have ended in
the past)
Clinical Trial Results – training
Environment
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EudraCT Result training environment
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Presentation title (to edit, click View > Header and Footer)
Your page
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EudraCT Result training environment
• Launched in August 2014
• URL link available on the EudraCT public website
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