0. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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