User Permissions

The tasks that can be performed by 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. user roles are outlined in the following table.

Click on a task title in the 'Functionality' column to open the page detailing the named task.

Prerequisites for User Roles:

For unregistered roles, access to the Internet is all that is required.
For registered roles, registration for the role through your NCAAcronym: National Competent Authority Responsible Contact or, for EMAAcronym: European Medicines Agency Users, via the EudraCT Service Desk: eudract@ema.europa.eu
Additionally, for roles other than PIP AddresseeThe PIP Addressee is the legal entity that has received the European Medicines Agency's decision on a Paediatric Investigation Plan (PIP)., access to EudraNet (EU Telematics systems page on EudraNet) is required in order to gain access to the EudraCT SECURE site.

**User Roles and Functionality in EudraCT PUBLIC and SECURE**
	Functionality	All Users (Public site)	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. Addressee (Log in Req'd) (*1)	NCA Editor	NCA Responsible Contact	EMA Editor	Viewer	Inspector (must also be a Viewer)
	Functionality	EudraCT PUBLIC (On Internet)		EudraCT SECURE (on EudraNet)
EudraCT NumberWhen registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan.	Generate EudraCT Number	•	•	•	•
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 Application	Create CTA	•		•	•
	Save as XML	•		•	•	•	•	• (*5)
	Switch XML	•		•	•	•	•	• (*5)
	Search CTAs in DB			•	•	•	•	• (*5)
	Save CTA in DB			•	•
	Validate CTA	•		•	•	•	•	•
	Compare CTA	•		•	•		•	•
	Load CTA	•		•	•
	Create Submission Package	•		•	•	•	•	•
	Update XML identifier	•		•	•	•	•	•
	Save as PDF	•		•	•	•	•	•
	Read Amendments			•	•	•	•	• (*5)
	Manage Amendments			•	•
	Read Reviews			•	•	•	•	• (*5)
	Manage Reviews			•	•
	Read Statuses			•	•	•	•	• (*5)
	Manage Statuses			•	•
	Discard changes			• (*)	•
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.	Create Third Country CTI	•	•
	Save as XML	•	•	•	•	•	•	• (*5)
	Switch XML	•	•	•	•	•	•	• (*5)
	Search Third Country CTI in DB			•	•	•	•	• (*5)
	Save Third Country CTI in DBAcronym: EudraCT's searchable DataBase.		• (*4)			• (*3)
	Validate CTA	•	•	•	•	•	•	• (*5)
	Load	•	•
	Create Submission Package	•	•	•	•	•	•	• (*5)
	Update XML identifier	•	•	•	•	•	•	• (*5)
	Save as PDF	•	•	•	•	•	•	• (*5)
Inspections	Manage Inspections							• (*2)
Inspections	Find and View Inspections			•	•	•	•	•

(*): Only when the user has reserved for edit the Clinical Trial

(*1): PIP Addressees with access to EudraNet may also use the same functionality described via EudraCT SECURE.

(*2): Only when Inspection and Inspector belong to the same organisation

(*3): Put in public search area, cannot edit uploaded Third Country CT.

(*4): Upload Third Country CTIAcronym: Clinical Trial Information. As distinct from a CTA, CTI refers to Third Country Clinical Trial Information. in a temporary area

(*5): Rights inherited to all Inspectors as they must also be members of the Viewer role.

Important Note: All Inspector users must also be Viewers. This assignment to roles occurs in ECD Manager application.

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