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Training session for Stakeholders

Training session for Stakeholders. Clinical Trial Results in EudraCT V10. Presented by: Noemi Manent Compliance and Inspection Service. Agenda. Purpose Legal basis requirements Clinical Trial Results in EudraCT V10 Q&A. Legal basis requirements.

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Training session for Stakeholders

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  1. Training session for Stakeholders Clinical Trial Results in EudraCT V10 • Presented by: Noemi Manent • Compliance and Inspection Service

  2. Agenda • Purpose • Legal basis requirements • Clinical Trial Results in EudraCT V10 • Q&A

  3. 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/news_detail_002127.jsp&mid=WC0b01ac058004d5c1

  4. Training session - CT Results in EudraCT V10 • Few examples are already available in the public domain: • structured data set • attachment

  5. 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)

  6. 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) • 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”.

  7. Results in EudraCT V10

  8. Results in EudraCT V10 • Finalised: • 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

  9. 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): • 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)

  10. Clinical Trial Results – training Environment

  11. EudraCT Result training environment Presentation title (to edit, click View > Header and Footer)

  12. Your page

  13. EudraCT Result training environment • Launched in August 2014 • URL link available on the EudraCT public website

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