Submit Third Country Clinical Trial Information

Task topic including steps necessary for submitting Third CountryA third country is a country outside of the European Union/European Economic Area. Clinical Trial Information.

This action should be performed only after the Third Country Clinical Trial Information has been completed and validated.

Note:If you are not sure that the Third Country Clinical Trial information has been validated, please select the 'Validate' option at the top of the Clinical Trial Application Menu and perform a validation.

Prerequisites for Submitting Third Country Clinical Trial Information:

To submit Third Country Clinical Trial Information to 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. Database, the following prerequisites apply:

Logged in under a PIP AddresseeThe PIP Addressee is the legal entity that has received the European Medicines Agency's decision on a Paediatric Investigation Plan (PIP). or EMAAcronym: European Medicines Agency Editor user role.

A locally saved Third Country Clinical Trial Information in XMLAcronym: eXtensible Markup Language format associated with a EudraCT NumberWhen registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan. for the same draft CTAAcronym: Clinical Trial Application.

Users are advised that this approach can be considered as the publication of a CTA within the EudraCT Database and PIP Addressees are responsible for the content of any such submissions. The CTA can now be searched for in EudraCT SECURE and within the publically accessible EUAcronym: European Union. CTR.

To access this functionality, you need to be logged into the EudraCT application under 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. Addressee role.

Next, you must load the Third Country Clinical Trial Information you wish to submit. See "Load a Clinical Trial Application or Third Country CT Information".

In the Clinical Trial Application Menu, check that the CT Information on the left hand side of the screen is correct, and ensure that the content of the Third Country CTIAcronym: Clinical Trial Information. As distinct from a CTA, CTI refers to Third Country Clinical Trial Information. has been validated and verified.

Once validated, the Task Bar at the top of the screen includes the option 'Submit':

Click ' Submit CTA

and the 'Submit Third Country XML' screen appears containing the 'Statement of the PIP Addressee':

If you understand and agree with the statement in green, click I agree button

The Third Country XML uploads to the EudraCT system. and the EudraCT Welcome Screen appears. The Third Country Clinical Trial Information is now stored within the EudraCTsystem.