As of 31 January 2023, all initial trial applications in the European Union (EU)/European Economic Area (EEA) must be submitted through CTIS. In case a new EU/EEA-country needs to be added to a EudraCT trial, the EudraCT trial needs to be transitioned to CTIS first: see Guidance for the Transition of clinical trials. The below documents provide additional support to complete the tasks described in the EudraCT step-by-step guide.
EudraCT third country protocol information ('third country file')
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
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