EudraCT
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EudraCT user manual


Registering a trial and updating its information
EudraCT number, CTA & Login for posting results
CTA & results documentation
Tutorials on posting results
Training
Frequently asked questions
National competent authorities
Statistics and technical documentation
EU Clinical Trials Register
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Welcome to the EudraCT public home page

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) is the database for all interventional clinical trials on medicinal products submitted to the National Competent Authorities (NCAs) of the European Union (EU)/European Economic Area (EEA) from 1 May 2004 to January 30th, 2023 under Directive 2001/20/EC, as well as for all trials conducted outside of the EEA that are part of a Paediatric Investigation Plan (PIP) and/or are conducted under Article 45 and 46 of Regulation (EC) No 1901/2006. Most of the protocol and results information of EudraCT trials is made publicly available through the European Union Clinical Trials Register (see FAQs).

As of 31 January 2022, the Clinical Trial Regulation (EU) No 536/2014 entered into application: EU/EEA trials can now be authorized through the Clinical Trial Information System (CTIS). The CTIS transition period is currently ongoing until 30 January 2023 included; as of 31 January 2023, all initial applications of EU/EEA trials must be submitted through CTIS.

From 31 January 2025, trials will no longer be allowed to continue under Directive 2001/20/EC: sponsors must transition any ongoing EudraCT trial to CTIS before this date.

The process of submission of protocol and results information through EudraCT is described in Registering a trial and updating its information.

Clinical Trial Application recommendation: sponsors are recommended to include a functional contact point in section B.5.6 of the Clinical Trial Application/third country file, rather than details of one "person", which would require more frequent updates.

Requirement to provide results: sponsors are required to post EudraCT trials’ results as per Joint Letter by the European Commission, EMA and HMA

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

CTIS: Clinical Trial Regulation, training material, homepage, legislation

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What's New

From 31 January 2023, sponsors will need to use the Clinical Trials Information System to apply for authorisation of a new clinical trial in the EU/EEA. From this date onwards, EudraCT will no longer allow the creation of new EU/EEA Clinical Trial Application (CTA) for the purpose of submission to National Competent Authorities (NCAs), including creation of CTA(s) in order to add member state(s) to an existing EudraCT trial. See section 11 of the Q&A on Regulation (EU) 536/2014.

EudraCT will remain available to sponsors for: amendments of CTAs that were submitted to NCAs before January 31st, 2023; creation and uploading of PIP/Art 46 trials conducted exclusively in third countries (see FAQs); results submission for all EudraCT trials.

07-12-2022

EudraCT and EU CTR experienced several unexpected downtimes recently. Both websites are now operational and users can access them. We apologise for any inconvenience caused and we thank you for your patience.

02-12-2022

Due to essential maintenance, the EudraCT website will have a downtime this evening between 6 pm and 8 pm (CET). We apologise for this inconvenience and we thank you very much for your patience.

22-11-2022

Sponsors of clinical trials on COVID-19 are reminded to include the term "COVID-19" in the title of their trial (section A.3 of the CTA). Sponsors are also reminded of the importance of timely reporting of SAEs (Serious Adverse Events) and of SUSARs (Suspected Unexpected Serious Adverse Reactions) to the competent authorities, in order to protect the safety of the participants. In addition, we encourage sponsors of COVID-19 trials to post the relevant results as soon as it is feasible, also before the deadline.

14-11-2022

Users have reported issues with uploading CTA XML files on EudraCT. Our IT is currently working on this, we thank you very much for your understanding and patience. Update 21Nov2022: this issue is now solved.

26-09-2022

Kindly note that the EMA Service Desk has changed to ServiceNow and can be accessed via https://support.ema.europa.eu/esc. If you cannot access through this portal, please report your issue or ask your question through using the email address EudraCT_notification@ema.europa.eu. We thank you very much for your collaboration.

31-08-2022

Due to essential maintenance of SPOR, the EudraCT website may experience momentary service losses on 3 and 4 September 2022. We apologise for this inconvenience and we thank you very much for your patience.

29-07-2022

A considerable amount of clinical trials are currently marked as "ongoing" in the EudraCT database. In view of the upcoming transition of trials to CTIS, sponsors are encouraged to verify whether the correct status of their trials is reported on EU CTR. An end of trial form needs to be submitted to National Competent Authorities for the trials that should be marked as “completed” or “prematurely ended”. In addition, sponsors are requested to post results of these trials as per European Commission guideline 2012/C 302/03: to know how to post results visit Tutorials on posting results. For questions, refer to Contact us.

30-06-2022

Following the issuing of the Joint Letter by the European Commission, EMA and HMA, National Competent Authorities and European Medicines Agency have sent reminders to sponsors who were not compliant with the European Commission guideline on results posting. Thanks to these reminders, the percentage of posted results substantially increased. However, for some trials the reminders were not successful: detailed lists of these trials can be found here.

03-03-2022

Following the European Commission's Guidance on results postings, the European Medicines Agency and National Competent Authorities sent rounds of notifications in order to remind sponsors of their responsibilities as regards posting clinical trial results in EudraCT. In an attempt to reach sponsors who have not uploaded results yet, round of reminders are now being sent to email addresses stored not only in EudraCT, but also in other databases, such as the EMA Eudra Common Directory (results user roles list), EudraVigilance, SPOR and Art. 57 database.

The EMA recommends all sponsors to verify if their trials comply with the Guidance on results postings through looking for their sponsor name in EU CTR. To learn how to post results visit Tutorials on posting results.

 

Previous news can be found here

 

For the UK, as of 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.


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