This concept topic is intended to differentiate between the two instances of 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. application to ensure users are clear as to their differing purposes and availability.
The publicly available area of EudraCT system, known as EudraCT PUBLIC, is intended to allow all applicants to create a EudraCT NumberWhen registered, each trial is issued with a unique EudraCT number, which identifies the protocol and trial throughout its lifespan. ("Create a EudraCT Number") then to draft, validate, compare and submit Clinical Trial Applications to National Competent Authorities, Independent Ethics Committees.
Additionally, it offers 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 secure access allowing them to draft, validate and submit Third CountryA third country is a country outside of the European Union/European Economic Area. Clinical Trial information, or to submit completed Third Country Clinical Trial information as an XMLAcronym: eXtensible Markup Language in order to save it to the EudraCT Database.
The securely available area of the EudraCT system, known as EudraCT SECURE, is intended to allow users (such as NCAAcronym: National Competent Authority employees) to create a EudraCT Number ("Create a EudraCT Number"), to validate, compare and submit Clinical Trial Applications using content supplied by applicants through the EudraCT PUBLIC submission package creation process, , or to draft Clinical Trial Applications from scratch.
Additionally, it offers search functionality for all Inspections, CTAs within the EudraCT database.
Finally, it provides a portal for Inspectors to perform their tasks of adding, loading, editing and saving information related to inspections.