User Management update - Stakeholders 03 May 2018 User Management update - Stakeholders EU Portal and EU database EU clinical trials portal and Union database meeting with Member States Presented by Noemi Manent on 24 February 2016 Compliance and Inspection department

Free open access. No registration or log-in required 03 May 2018 EU portal and database – Business context view This diagram depicts the To-Be system architecture for the submission of Clinical Trial Application Dossiers and Results: Sponsors (Industry + Academia) Member States (NCA + Ethics Committee) EMA Applicant of MA EU Comm. General public Symbol Key User access service Interface Portal / website Databases CT system Provides information BI reports Free open access. No registration or log-in required IAM Sponsor App of MA Initial production version MS EC Safety Portal Workspace EMA EU Portal Public Website S P O R Safety databases EVCTM ASR Repository XEVMPD S P O Workspace database EU database MS systems Document store & structured data Document store & structured data Informatica R Sponsor systems Informatica S P O R Data warehouse WHO system Future MDM solution Reports Reports accessible by the EMA, Member States & Commission (Sponsors & General public can view pre-defined reports) User Management update - Stakeholders

Free open access. No registration or log-in required 03 May 2018 EU portal and database – Interaction with IAM This diagram highlights how the EU portal and database will interact with the Identity Access Management (IAM) solution: Sponsors (Industry + Academia) Member States (NCA + Ethics Committee) EMA Applicant of MA EU Comm. General public Symbol Key User access service Interface Portal / website Databases CT system Provides information BI reports Free open access. No registration or log-in required IAM Sponsor App of MA Initial production version The IAM system will authenticate registered users of the EU portal and database by linking an individual to an account and allowing the account to be linked to multiple organisations. MS EC Safety Portal Workspace EMA EU Portal Public Website S P O R Safety databases EVCTM ASR Repository XEVMPD S P O Workspace database EU database MS systems Document store & structured data Document store & structured data Informatica R Sponsor systems Informatica S P O R Data warehouse WHO system Future MDM solution Reports Reports accessible by the EMA, Member States & Commission (Sponsors & General public can view pre-defined reports) User Managemnet update - Stakeholders

User management overview (Sponsors) 03 May 2018 EU portal and database – User management User management overview (Sponsors) Self register on to the Portal Assign roles and work packages to users including administrators Invite users to access trial Trial-centric access Sponsors/ CT administrators can choose to limit access management to a specific clinical trial only Sponsors Organisation- based access Sponsors and applicants can formally register and appoint sponsor administrators, who in turn can manage users and assign roles and access across multiple Clinical Trial Applications Sponsors User Managemnet update - Stakeholders

Trial-centric access 03 May 2018 CT User 2 invite create Validate CTA Invitation rights Read only Edit (except IMPD) Edit IMPD Submit Invite others User 2 invite create Validate CTA Submit Self registration with EMA Create Sponsor Applicant User 1 CT Member State Create other organisations Mark Organisations as reusable Check for duplicates Site How many trials per Sponsor? Only after org duplicate check is done Anyone can submit a CTA on behalf of an unregistered sponsor Higher probability of bad/duplicate Data User Managemnet update - Stakeholders

Organisation-centric access 03 May 2018 Organisation-centric access Invitation rights Read only Edit (except IMPD) Edit IMPD Submit Invite others User 2 invite create Submit Select sponsor Member State CT Wait for authorisation Applicant User 1 Registered Sponsor Self registration with EMA Validate user Site Create other organisation Org Admin Applicants are validated The applicant is likely to be from the sponsor Data has a higher probability to be correct Select sponsor Applicant User 2 Self registration with EMA User Managemnet update - Stakeholders

EU portal and database – User management The organisation-based access for sponsors requires a more formal registration process creates the opportunity for management of access and roles across trials Improves security Leads to better data quality The Trial centric approach allows a faster process in case of a first initial application, Can lead more easily to duplicate sponsor data Becomes less convenient if an organisation applies for/runs multiple trials User Managemnet update - Stakeholders

Key Requirements All users will need to be self-registered in the EMA systems before they can access the EU Portal & EU Database The user registering a Sponsor organisation shall become the organisation administrator by default, unless an alternative administrator has been suggested. Organisation administrators shall be able to validate whether they would like users to perform actions on behalf of their organisation, thus allowing the user to be affiliated with their organisation. The user creating the trial will be the administrator of that clinical trial (CT administrator). A CT administrator will be able to authorise other users to access the clinical trial even outside the sponsor provided that these users are already self-registered in the system. User Managemnet update - Stakeholders

Key Requirements The CT administrator will only have access to the clinical trials for which he/she is administrator (regardless of who is the sponsor administrator) while the sponsor administrator will have access to all clinical trials that the sponsor organisation is responsible for. The users of the EU Portal will have access to the Portal functions according to their role, so the system will display the appropriate data and also the appropriate activities for them. User Managemnet update - Stakeholders

User management Sponsor organisation administrator tasks Create additional administrator users Administration of all users linked to sponsor CT administrator for all sponsor trials Sponsor administrator CT administrator CT user Additional sponsor administrator Additional CT administrator CT administrator tasks Create additional CT administrator users Select CT users by delegating the appropriate work packages to already registered users Administration of CT users User Managemnet update - Stakeholders