Accessing EudraCT v.8

The following user roles are available in the EudraCTEudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC. system.

Unregistered Roles

Public site user

All users who can access the EudraCT PUBLIC site:https://eudract.ema.europa.eu/
This user role is functional only in EudraCT PUBLIC.
To view the table of permissions relating to all roles, "User Permissions"

Registered Roles

To register for roles, contact your NCA Responsible Contact, or if within the Agency, contact the EudraCT Service Desk at eudract@ema.europa.eu.

PIP Addressee users are normally registered at the time of the PIPAcronym: Paediatric Investigation Plan. Document upon which the development and authorisation of medicinal products for the paediatric population is based. It is presented by an applicant early during the development of a product to the EMA Paediatric Committee in order to agree a paediatric development plan. application.

PIP Addressee

Users of this role can create Third CountryA third country is a country outside of the European Union/European Economic Area. CTAcronym: Clinical Trial - A Clinical Trial Application becomes a Clinical Trial and is searchable within EudraCT once approved. Information XMLAcronym: eXtensible Markup Languages in PUBLIC or SECURE site, but they cannot save CTs into EudraCT's Database. They can only upload the Third CountryA third country is a country outside of the European Union/European Economic Area. CT Information XMLs to the SECURE site so that EMA Editors can make them public.
The user role is functional in both EudraCT PUBLIC and EudraCT SECURE.
To view the table of permissions relating to all roles, "User Permissions".

Viewer

Users of this role can search and view Clinical Trial and Inspection data, but they cannot edit or load CTAs or CTs in the system.
The user role is functional only in EudraCT SECURE.
To view the table of permissions relating to all roles, "User Permissions".

NCA Editor

An Editor belonging to an NCA organisation (which includes EMA for Third CountryA third country is a country outside of the European Union/European Economic Area. CTs from PIPAcronym: Paediatric Investigation Plan. Document upon which the development and authorisation of medicinal products for the paediatric population is based. It is presented by an applicant early during the development of a product to the EMA Paediatric Committee in order to agree a paediatric development plan. Addressees). NCA Editors have write access for EEAAcronym: European Economic Area. Created in 1994, the EEA combines the countries of the European Union and member countries of EFTA (European Trade Association) Countries that belong to the EEA are: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom. Countries that are EEA member countries but NOT part of the European Union are: Norway, Iceland, and Liechtenstein. CTAAcronym: Clinical Trial Applications and the associated Reviews, Amendments, Interruptions or Completions.
NCA Editors have read access to Third Country CTAcronym: Clinical Trial - A Clinical Trial Application becomes a Clinical Trial and is searchable within EudraCT once approved.s and Inspections (EMA/NCA Editors have read/write access).
The user role is functional only in EudraCT SECURE.
To view the table of permissions relating to all roles, "User Permissions".

NCA Responsible Contact

A supervising NCA Editor that may additionally discard changes made by NCA Editors.
This user can also manage the roles for the users in their NCA in ECD manager application (external to EudraCT).
The user role is functional only in EudraCT SECURE.
To view the table of permissions relating to all roles, "User Permissions".

Inspector

Users of this role can only manage (create, delete, upload and modify) Inspections. Inspectors belong to NCAAcronym: National Competent Authoritys.
Members of the inspector role should also be members of the Viewer role (must be entered as such in ECD ManagerAcronym: Eudra Common Directory Manager - A user management application managed and maintained by the European Medicines Agency. application) so they can Search and View Clinical Trials
This user can also manage the roles for the users in their NCA in ECD manager application (external to EudraCT).
The user role is functional only in EudraCT SECURE.
To view the table of permissions relating to all roles, "User Permissions".

User Roles Overview

Unregistered Roles

Registered Roles