Welcome to EudraCT

As of 31 January 2023, creation and submission of new Clinical Trial Applications (CTAs) for trials to be conducted in the EU/EEA is no longer allowed through EudraCT and must be performed through the Clinical Trials Information System . Please find below an overview of the actions that can still be performed through EudraCT. Specific instructions are provided in the EudraCT User manual and Step-by-step guide.

Create a EudraCT number for a third country file

As of 31 January 2023, EudraCT only allows the creation of new EudraCT numbers for trials conducted exclusively outside of the EU/EEA that are part of a Paediatric Investigation Plan (PIP) and/or in scope of Article 46 of the Paediatric Regulation (EC) 1901/2006 (so called "third country file").

With regards to PIP/Art 46 trials that are going to be conducted within the EU/EEA, and for PIP/Art 46 trials that are going to be conducted both in the EU/EEA and in third countries, a single application must be submitted through the Clinical Trials Information System

Information on Clinical Trial Protocols

From 31 January 2023, sponsors must use the Clinical Trials Information System to create an initial application for a new clinical trial to be conducted in the EU/EEA. Sponsors are also required to transition their trials to CTIS in case:

• Their EudraCT trial is going to be conducted in additional EU/EEA member state(s), for which a EudraCT CTA was not submitted to the relevant National Competent Authority (NCA) before 31 January 2023
• Their EudraCT trial completion date is expected to be after 30 January 2025

In case of a multi-country trial, Sponsors should ensure the harmonisation of their clinical trial under the Directive through EudraCT, prior to transitioning their trial to CTIS: please refer to the Clinical Trials Regulation Q&A section 11 for more information.

Sponsors can amend EU/EEA EudraCT CTA XML files that were submitted to NCAs before 31 January 2023 in the following ways:

• through loading the XML file of their EudraCT CTA from a local drive via the Load EEA CTA option
• through creating a new CTA XML file. This option is given to sponsors only in case they have lost the XML file of the EudraCT CTA that was submitted to the NCA before 31 January 2023. This option must not be used to create initial applications, including new member state applications for existing EudraCT trials.

Upon amendment of the CTA XML file of an existing EudraCT trial, after validation, the relevant package can be created and submitted to the relevant National Competent Authority(ies).

Third country data providers can continue to use the EudraCT database to create and post a third country XML file. Please note that a sponsor user should request the Third Country Data Provider role to be added to their EMA-account prior to posting. This can be requested via the EMA ServiceNow. Please refer to the FAQ for more information.

Please note that EudraCT is an application for the creation/amendment of CTAs/third country XML files. Those files are not saved in EudraCT. To retain information, the sponsor must actively download and save those XML files on a local drive.

EU/EEA National Competent Authorities use the EudraCT website to update information on existing EudraCT Clinical Trial Applications regarding:

• approval of new EU/EEA Clinical Trial Applications that were submitted before 31 January 2023
• upload of amendments to EU/EEA CTAs for existing EudraCT trials (for which the initial application was submitted to the relevant NCA(s) before 31 January 2023)
• update the trial status of EU/EEA EudraCT CTAs as informed by the sponsor.

Results related information

Sponsors are responsible for posting their EudraCT trials' results through logging in EudraCT, assigning themselves a "results user role" and requesting to become the primary user for their trials: see Tutorials on posting results for detailed instructions. Once a trial assigned to a primary user, it is possible to:

• nominate back up user for their trials (the back-up user needs to be a "results user", first).
• create or load locally saved EudraCT results XML files in order to edit, validate and post them as a "full data set"
• upload and post a "summary attachment" with (partial) results of a trial, or with a justification of missing results for a prematurely ended trial.

The Frequently Asked Questions document clarifies under which conditions results must be posted as a "full data set" and in which cases a "summary attachment" suffices. It also provides answers to the most common issues a sponsor may encounter throughout this process.