1. An agency of the European Union 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 1

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/new s_detail_002127.jsp&mid=WC0b01ac058004d5c1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/06/new s_detail_002127.jsp&mid=WC0b01ac058004d5c1 2

4. Training session - CT Results in EudraCT V10  Few examples are already available in the public domain:  structured data set  attachment 3

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) 4

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”. 5

7. Results in EudraCT V10 6

8.  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 7

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) 8

10. Clinical Trial Results – training Environment 9

11. EudraCT Result training environment Presentation title (to edit, click View > Header and Footer)10

12. Your page 11

13. EudraCT Result training environment Launched in August 2014 URL link available on the EudraCT public website 12