1. EudraCT V10 and the clinical trial regulation
DIA clinical trial disclosure community call
Presented by: Noémie Manent
Compliance and Inspections

2. Disclaimer
The views presented in this presentation/these slides are those of the author and should not be understood or quoted as being made on behalf of the European Medicines Agency and/or its scientific committees

3. Agenda
EudraCT V10 protocol and results
The Clinical trial regulation

4. EudraCT V10 protocol and results
CT Regulation

5. Legal Framework: Article 11 of Directive 2001/20/EC
EudraCT
Legal Framework: Article 11 of Directive 2001/20/EC
One trial consists of a clinical trial application dossier per MS (for interventional trials)
A clinical trial application dossier consists of several documents but only the clinical trial application (CTA) is uploaded in the database (EudraCT)
The database is only accessible by the Competent Authorities, European Commission and EMA
Since October 2013, Sponsors can log in to prepare and post the summary results of CT
Source of data for EU CTR 4 4

6. National Competent Authority (NCA) EU Clinical Trial Register
Sponsor submit to NCA and Ethics Committee the CT application dossier including the clinical trial application.
Same apply to substantial and other notifications (end of trial notifications, clinical study report)
Create Clinical Trial Application &
substantial amendment
CTA & substantial amendment
upload & review
National Competent Authority (NCA)
Create Submission Package
Sponsor/PIP.A
Record NCA & Ethics Committee
Decision
EudraCT Database
Record EOT Notification
Create and post
CT results
Notify decision to Sponsor
CTAs Public
CT Results Public
EU Clinical Trial Register
Notify decision to sponsor
Ethics Committee
Key:
= External Flow
= EudraCT Public
= EudraCT Secure
= Public Information

7. PAT ICH Q8, ICH Q9 - EU Regulatory PerspectiveRegulations: help or hurdle to innovation

8. EudraCT V10 & EU CTR V2.1 latest upgrade
An upgrade was launched last week and the scope of the release includes: - Automatic assignment of results users based on CTA information (Sponsor) - View results in EudraCT Secure (NCA) - Search for Art 45 trials (Paed regulation) in EU-CTR (Public) - Upload of Art 46 trials (Paed regulation) to EudraCT Public (Sponsor/Third country data provider) - Upgrade related to substance information that is now collected the SMS service (Sponsor/NCA/Public)

9. Q&A Refer to the Q&A document
Example of the view of the results (full data set) in the EU CTR

10. PDF view (mock up data)
PAT ICH Q8, ICH Q9 - EU Regulatory PerspectiveRegulations: help or hurdle to innovation

11. EU CTR view (mock up data)

12. EU CTR view (mock up data)

13. The Clinical Trial Regulation

14. Motivations behind the CT regulation
Make the CT Dossier Application process easier and shorter especially for multi-state trials
Create a one-stop shop for several stakeholders who are involved in the
Application
Authorization
Monitoring
Reporting of results
Provide transparency for the whole lifecycle of clinical trials
CT Regulation

15. Main actors/users Member States (NCAs and Ethics Committee)
Sponsors (academic and commercial)
MAH
European Commission
EMA
Members of the public
CT Regulation

16. CT system components Clinical trial portal Union database MS workspace
Sponsor workspace
User access control
Dataware house
IMP and substance dictionary
EV SUSAR reporting and annual safety reporting
EudraCT/EU CTR and its legacy
CT Regulation

17. CT Regulation

18. Implementation
Publication in the Official Journal of the European Union expected this month.
To come into force at least two years after publication
Transition period of one year during which EudraCT can be used
The requirements and modalities for posting results will not be affected until the EU portal and database are launched. Some adjustments may be anticipated.