EudraCT supporting documents

All clinical trials in the European Union (EU)/European Economic Area (EEA) that are ongoing after 30 January 2025 must comply with the Clinical Trial Regulation (EU) 536/2014 and, therefore, should have been submitted to the Clinical Trials Information System (CTIS).

The below documents provide additional support to complete the tasks described in the EudraCT step-by-step guide. Additional information can be found on our Frequently Asked Questions.

EudraCT third country protocol information ('third country file')

• Legislation: Paediatric Regulation (EC) No 1901/2006


• Process: Step-by-step, user manual, Frequently asked questions (see sections on third country trials).


• Instructions for data completion: CTA Pick lists and Coded Values, Data dictionary, Tabular and XML format.


• Schema: Third country file, XML Schemas v.8.1;

EudraCT EU/EEA Clinical Trial Application

• Legislation: Eudralex Vol 10, Chapter 1, Annex I: CTA form


• Process: Step-by-step, User manual, Frequently asked questions (see sections on protocol information).


• Instructions for data completion: CTA Pick lists and Coded Values, Data dictionary; Validation rules v.8.2 (31/5/2012) EEA CTA - tabular and XML format


• CTA v7 to v8: How to convert v7 to v8, v8.1 guidance, Tool tips for IE6 users (v8.0), New fields in v8.0 , Country Mapping List, Controlled Terms Mapping List


• Schemas: EEA CTA, XML Schemas v.8.1; Gateway technical specification, acknowledgement message, main message, message header


• Brexit: Joint Technical Notice to Sponsors by the European Commission, EMA and HMA and Notice to stakeholders of 7 May 2020

EudraCT Results

• Legislation: Commission guideline, Joint letter signed by EC, EMA and HMA, Modalities and timing of posting


• Process: Tutorials on posting results (step 2 documents: primary user request form, guidance for completing, service level agreement), Frequently asked questions (see section on results information).


• Instructions for data completion: Validation rules to correct errors/warnings, Data dictionary and XML schemas of the full data set.

EudraCT Statistics and technical documentation