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

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

Agenda EudraCT V10 protocol and results The Clinical trial regulation

EudraCT V10 protocol and results CT Regulation

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

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

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

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)

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

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

EU CTR view (mock up data)

EU CTR view (mock up data)

The Clinical Trial Regulation

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

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

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

CT Regulation

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.