EudraCT

The public side of EudraCT is for organisations to register any of their clinical trials as defined by Directive 2001/20/EC. The process of applying and registering a clinical trial should be completed before submitting an application to any of the Member State/s in which they anticipate running the trial. The public side of EudraCT does not save any of the trial detail entered by the user, and instead provides a saved data file in the form of an XML which the user must store on their own local hard drive. Applying for an EudraCT Number Application for a EudraCT number is made via the EudraCT website. To generate the EudraCT number some basic information about the requestor's organisation and the trial is required: • Requestor's organisation name, town/city and country. • Sponsor's protocol number. • Requestor name. • E-mail to which the EudraCT number will be sent. • Security code. • Whether the clinical trial is contained in a Paediatric Investigation Plan (PIP). • Whether the clinical trial will be conducted in a third country (outside of the EU/EEA). • The Member States where it is anticipated that the trial will be run. Once the requestor submits the form, the EudraCT Number will be assigned and an e-mail called "EudraCT Receipt" sent. The EudraCT number has the format YYYY-NNNNNN-CC, where: • YYYY is the year in which the number is issued. • NNNNNN is a six digit sequential number. • CC is a check digit. The Clinical Trial Application (CTA) form is also created via the EudraCT system. ==Version details==

The EudraCT database is currently on Version 9. Current Versions Version 9 of EudraCT was released in November 2013. New features for Version 9 include: Protocol-related information Sponsors can: • Create, save XML/PDF files of clinical trial applications locally. • Load locally saved clinical trial applications to complete, validate, compare, or to prepare a package for submission to a National Competent Authority. PIP addressees can: • Create, save XML/PDF files of third country files locally. • Create and post third country files to the EudraCT database. • Load locally saved third country files to complete, validate or post to the EudraCT database. To post third country files you will need to be registered as a PIP addressee. Result-related information • To use result related functionality you will need to be registered as a results user, and log in. Results users can: • Create, update, validate and post result data sets, and load summary attachments to the EudraCT database. • Save locally XML/PDF files of result data sets. • Upload XML files. ==Member States==