Purpose of EudraCT and the Clinical Trial Application

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. is a database of all clinical trials commencing in the Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC.

EudraCT gives the sponsor and 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 access to the EudraCT application, in order to:

• Get a EudraCT number ("Create a EudraCT Number").
• Draft a Clinical Trial Application ("Create Clinical Trial Application/Third Country CT Information" ).
• Draft Third CountryA third country is a country outside of the European Union/European Economic Area. Clinical Trial Information ("Create Clinical Trial Application/Third Country CT Information" ).
• Complete, save a CTAAcronym: Clinical Trial Application or Third Country Clinical Trial Information locally (" Save a Clinical Trial Application or Third Country Clinical Trial Information as XML") and print a PDFAcronym: Portable Document Format (PDF) is an open standard for document exchange. The file format created by Adobe Systems in 1993 is used for representing two-dimensional documents in a manner independent of the application software, hardware, and operating system. version of the Clinical Trial Application form (" Save a CTA or Third Country Clinical Trial Information as PDF").
• Create a Submission Package (" Prepare a Submission Package") for despatch to a NCAAcronym: National Competent Authority contact, IECAcronym: Independent Ethics Committee contact, or 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 (in the case of Third CountryA third country is a country outside of the European Union/European Economic Area. Clinical Trial Information).