EU CT Portal and Database SME I nfo day – The New Clinical Trials Regulation Presented by Noemie Manent, Scientific Administrator Clinical & Non-clinical Compliance , European Medicines Agency 20 March 2017 An agency of the European Union
Systems to implement the new regulation • Single EU entry point for clinical trial applications • Enables supervision at EU level , including inspections EU PORTAL • Provides w orkspace collaboration tools, workflow and AND DATABASE document management capabilities • Provides publicly available information • Delivers transition between the current and new systems EUDRACT LEGACY 1 The EU Portal and Database
Regulation (EU) No. 536/ 2014 • Single EU portal and database to support: – One application dossier for each clinical trial or modification – Coordinated approach to clinical trial assessment, authorisation and supervision – Transparency of clinical trial information • One application dossier ( e-dossier) : – Part I common to all Member State Concerned (MSC) – Specific country part II (for each MSC) – A single decision in each MSC (scientific & ethical review) – Public registration of the trial and its subsequent updates, including the necessary elements of international registration at WHO ICTRP portal – Providing the trial design elements to support subsequent entry and publication of the summary of results The EU Portal and Database 2
Regulation (EU) No. 536/ 2014 • Sim plifications for Sponsors, for EU/ EEA Mem ber State: - Uniform procedure in EU: whether single or multi- country clinical trials (CT) - Communication hub: Electronically by Portal - Unique clinical trial number - 1 Contact per CT part I: Reporting Member State (RMS) - 1 Common assessment (part I) by all concerned MS together - 1 Decision per MS (Part I + II) - 1 Fee per MS (if applicable) 3 The EU Portal and Database
The EU Portal and Database: System functionality overview 4 The EU Portal and Database
Collaborative working The EMA is working collaboratively EUROPEAN EUROPEAN MEDI CI NES COMMI SSI ON AGENCY STAKEHOLDERS MEMBER STATES - Sponsors & ETHI CS - CROs COMMI TEES - Health Care Professionals - Patient Representatives to develop systems to implement the regulation 5 The EU Portal and Database
EU portal and database – business context view This diagram depicts the To-Be system architecture for the clinical trial systems: Sponsors Mem ber States EMA Applicant of EU Com m . General public ( I ndustry + ( NCA + Ethics MA Academ ia) Com m ittee) Sym bol Key User access service Free open access. No IAM I nterface registration or log-in required Portal / website Sponsor Initial production App of MA Databases version MS CT system EC Safety EU W orkspace Public W ebsite EMA Portal Portal S P O R Provides information BI reports XEVMPD S P O Safety databases W orkspace database EU database EVCTM Document store & structured Document store & structured MS system s R I nform atica ASR Repository data data Sponsor system s I nform atica S P O R Data w arehouse W HO system Reports accessible by the EMA, Mem ber States & Com m ission Future MDM solution Reports ( Sponsors & General public can view pre-defined reports) 6 The EU Portal and Database
Activities in the system Notification of willingness to be Submit application (CTA dossier) Submission Submission of Union RMS (part I) / Decision on RMS / Address request for information of CSR Control Reports Submission of requests for Update of Clinical Trial Applicant Commission Submission of requests for information information (re non substantial information of a MA modifications) Notification of the final Notification of the final Submit notifications: validation (initial, additional MS validation (initial, additional MS • Start of trial or Substantial Modification) or Substantial Modification) • First visit first subject Submission final conclusion to Submission final AR Part 1 and • End of recruitment Member Member Part I and Part II 2 • End of trial (in each MS, All Sponsors States States MS, Global) Final single decision notification Final single decision notification • Temporary halt & restart Submission Inspection Submission Inspection • Serious Breach, Unexpected Information Information event, urgent safety measure • Inspection from third country Communication disagreement Communication disagreement General Search and view inspectorate to part 1 assessment to part 1 assessment public CT information Submission of clinical study Communication on System result (summary and lay person implementation of corrective EMA Maintenance summary) measures 7 The EU Portal and Database
High level system overview Subm ission W orkspace for Sponsors Clinical Trials Overview and Search Requests for inform ation & notices • Search for trials I have access to • See formal or informal requests for information from • See current state of my trials Member States and respond • Select and initiate new trials / change trials • See deadlines for requests / notifications associated to trial CT Application Dossier • See all alerts and notices for all my trials • Complete application dossier to create a new trial Sponsor User m anagem ent (initial application) • Update an existing trial already authorised and create • Self register on to the Portal substantial modification application or additional MSC • Assign roles to users including administrators application • Invite users to access trial • Provide notifications for authorised trial. Docum ents System interfaces • Upload documents to the clinical trial application • Import clinical trial application into the portal • Ability to mass upload documents • Submit notifications to the CT portal • Ability to copy documents from an existing trial • Submit results to a clinical trial • Ability to version control uploaded documents 20
High level system overview Authority W orkspace for Member States Clinical trial overview & search Task list • Provides an overview of all tasks to be done by me or • A search for all clinical trials (documents are restricted to MSC) my group with deadline Clinical trial detail • Users will be notified of new tasks via alerts upon login • An overview of one trial including: the application dossier, • Able to open a specific item to see the task details including structured data and documents, status, timetable, I nspection associated tasks, version history • Record and upload inspection records inspections linked • Ability to collaborate on national considerations on Parts I and II to sites and clinical trials • Formal or informal Request for Information to the sponsor Mem ber States user m anagem ent • Ability to supervise and issue corrective measure • Member State (MS) Administrator for each MS Tasks • The MS Administrator to assign access to national NCA • Task-specific forms relating to the activities of Member States and Ethics Committee administrators (select RMS, document considerations, make a decision, etc.) • National CA and Ethics Committee administrators are • Ability to open the details of the clinical trial dossier responsible for managing their user base • Delegate Task, Create subtask and involve more people from this System interfaces MSC (e.g. ethics committee) • A REST Service interface (CRUD) is used for all entities. Docum ents The majority will be exposed in the EudraNet for MSCs • Download documents and data submitted by the sponsor to consume. Examples: Read trial, upload data and • Upload documents (e.g. assessment reports) structured data relating to trials, etc. 21
High level system overview Public w ebsite for the public, EMA and MSCs Public Clinical Trial Data Entry site • Go into the detail of a clinical trial • News, announcements, scheduled downtimes • Download trial information and documents • View publicly available statistics on clinical trials • View and download predefined reports registered in the EU Database • Available in all official languages of the European Public Search Content Managem ent ( EMA) Union • Search for keywords and filter results • Go into the detail of a clinical trial • Find public clinical trials (the same portal also • Download trial information and documents contains pro active publications, medicinal products, • Publish clinical trail data articles,… ) • Remove clinical trial data from public view EU portal and database 22
Pre-population of data SPOR (Substance, Product, Organisation, referential) data in the Clinical Trial (CT) Application is selected/ populated from master data stores: • S: Substance management system Master Data • P: Medicinal Product Dictionary (including Substances) • O: Organisation management system • R: Referentials Summary Trial data from the CTA is used to pre-populate summary Results results data structures where applicable Document Standard document output can be pre-populated with CTA generation and CT data where applicable EU portal and database 11 The EU Portal and Database
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