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<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"> <html> <head> <title>EudraCT Public website - Home page</title> <meta http-equiv="Content-Type" content="text/html; charset=UTF-8" /> <link href="css/eudractold.css" rel="stylesheet" type="text/css"/> <link href="css/eudract.css" rel="stylesheet" type="text/css"/>  <script language="JavaScript" type="text/javascript" src="Styles/common_functions.js"></script> <style type="text/css">  </style> </head> <body lang="EN-US">  <table class="headerTableGlobal" width="100%" cellspacing="0" cellpadding="0"> <tr width="100%"> <td id="rowTop1"align="left"><img src="images/eudractlefthead.png" alt="EudraCT"/></td> <td id="rowTop2" align="right" ></td> </tr>   <tr width="100%"> <td align="left" id="rowBottom1"> </td> <td align="right" id="rowBottom2" >Hosted on behalf of the European Commission<a href="http://ec.europa.eu/index_en.htm" title="European Commission" target="_blank"><img src="images/smalleuflag.gif" width="30" height="20" alt="EU"></a></td> </tr> </table>  <div id="Layer3" style="position: absolute; width: 211px; height: 115px; z-index: 3; top: 70px; left: 9px; visibility: visible;"> <table width="100%" border="0" cellpadding="1" cellspacing="0"> <tr> <td class="textBody"><a href="index.html">Home</a></td> </tr> <tr><td class="line"></td></tr> <tr> <td class="textBody"><a href="https://eudract.ema.europa.eu/results-web/" target="_blank">EudraCT tools & Login</a></td> </tr> <tr><td class="line"></td></tr> <tr> <td class="textBody"><a href="protocol.html">EudraCT step-by-step guide</a></td> </tr> <tr><td class="line"></td></tr> <tr> <td class="textBody"><a href="multimedia_tutorials.html">Tutorials on posting results</a></td> </tr> <tr><td class="line"></td></tr> <tr> <td class="textBody"><a href="training.html">User manual and training</a></td> </tr> <tr><td class="line"></td></tr> <tr> <td class="textBody"><a href="result.html">Supporting documents</a></td> </tr> <tr><td class="line"></td></tr> <tr> <td class="textBody"><a href="docs/guidance/EudraCT FAQ_for publication.pdf" target="_blank">Frequently asked questions</a></td> </tr> <tr><td class="line"></td></tr> <tr> <td class="textBody"><a href="nca_contacts.html">National competent authorities</a></td> </tr> <tr><td class="line"></td></tr> <tr> <td class="textBody"><a href="https://www.clinicaltrialsregister.eu/ctr-search/search/" target="_blank">EU Clinical Trials Register</a></td> </tr> <tr><td class="line"></td></tr> <tr> <td class="textBody"><a href="contact.html">Need Help? Contact us!</a></td> </tr> <![if ! IE 6]> <div> <tr> <td class="line"></td> </tr> </div> <![endif]> </table> </div> <table width="1083" table style="margin-left:225px; margin-right:145px;"> <tr> <td width="1278" bgcolor="#F3F3F3" class="textBody"> <a href="https://euclinicaltrials.eu/about-this-website#transition-period "><img src="images/2024-01_CTIS banner_EudraCT website.png" width="1100" height="134" ></a> </td> <tr> <td bgcolor="#FFFFFF" class="textBody"><h1>Welcome to the EudraCT public home page</h1> 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 until 30 January 2023 under <a href="https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A02001L0020-20090807" target="_blank">Directive 2001/20/EC</a>, 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 or 46 of <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R1901" target="_blank">Regulation (EC) No 1901/2006</a>. Most of the protocol and results information of EudraCT trials is made publicly available through the <a href="https://www.clinicaltrialsregister.eu/ctr-search/search" target="_blank">European Union Clinical Trials Register</a> (see <a href="https://eudract.ema.europa.eu/docs/guidance/EudraCT FAQ_for publication.pdf" target="_blank">Frequently Asked Questions</a>). Any EU/EEA trial with a foreseen Last patient last visit* after 30 January 2025 is required to transition to the <a href="https://euclinicaltrials.eu/" target="_blank">Clinical Trials Information System</a> to comply with <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536" target="_blank">Regulation (EU) 536/2014</a>. This needs to be done as soon as possible, since this deadline includes the time necessary for completion of the Member State(s) procedure, which can take up to 3 months. More information <a href="https://euclinicaltrials.eu/guidance-and-q-as/#qas-transitioning" target="_blank">here</a>. If your trial is expected to continue after 30 January 2025: see <a href="https://euclinicaltrials.eu/documents/20482/2813837/CTIS how to get started and how to transition a trial.pdf/CTIS how to get started and how to transition a trial.pdf">CTIS: how to get started and how to transition a trial</a>. 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: see <a href="https://health.ec.europa.eu/document/download/10c83e6b-2587-420d-9204-d49c2f75f476_en?filename=transition_ct_dir-reg_guidance_en.pdf">Guidance for the Transition of clinical trials</a>. *This applies to all trials having at least one active site in the EU/EEA ('Active site' in the context of <a href="https://health.ec.europa.eu/document/download/10c83e6b-2587-420d-9204-d49c2f75f476_en?filename=transition_ct_dir-reg_guidance_en.pdf">transition trials</a> means that the last visit of the last subject, or other trial-specific interventions with the subject specified in the protocol) as well as to any EudraCT trial for which an additional member state application needs to be submitted. As of 31 January 2023, all initial clinical trial applications in the European Union (EU)/European Economic Area (EEA) must be submitted through the <a href="https://euclinicaltrials.eu/home"> Clinical Trials Information System</a>. As per <a href="protocol.html">EudraCT step-by-step guide</a>, the <a href="training.html">use of the EudraCT database</a> is now limited to: <ul> <li>the performance of amendments to EU/EEA Clinical Trial Applications for which the initial submission was done before 31 January 2023, for all trials foreseen to complete before 31 January 2025</li> <li>the upload of third country files of 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 files”)</li> <li>the update of EudraCT trial statuses by <a href="nca_contacts.html" target="_blank">National Competent Authorities</a>, for all trials foreseen to complete before 31 January 2025</li> <li>the <a href="/multimedia_tutorials.html">submission of results</a> of EudraCT trials by sponsors</li> </ul> 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 <a href="https://eudract.ema.europa.eu/multimedia_tutorials.html" target="_blank">post EudraCT trials' results</a> as per <a href="https://eudract.ema.europa.eu/docs/guidance/1R - Joint letter signed by EC, EMA, HMA_en.pdf" target="_blank">Joint Letter by the European Commission, EMA and HMA</a> CTIS: <a href="https://euclinicaltrials.eu/documents/20482/2813837/CTIS how to get started and how to transition a trial.pdf/CTIS how to get started and how to transition a trial.pdf" target="_blank">how to get started and how to transition a trial</a> <a href="rss/eudract_rss.xml"><img src="images/rss_logo.png" width="75" height="30" alt="RSS"></a> <tr> <td width="1278" bgcolor="#F3F3F3" class="textBody"> <h1>What's New </h1> Sponsors of EU/EEA EudraCT trials that are expected to continue after 30 January 2025 are required to <a href="https://euclinicaltrials.eu/guidance-and-q-as/#qas-transitioning" target="_blank">transition those trials to the CTIS</a> at their earliest convenience. It's important to be aware that the timeframe for the Member State(s) procedure, which can take up to 3 months, is part of the provided deadline. To know how to transition your trial, see <a href="https://euclinicaltrials.eu/documents/20482/2813837/CTIS how to get started and how to transition a trial.pdf/CTIS how to get started and how to transition a trial.pdf" target="_blank">CTIS: how to get started and how to transition a trial</a>. 09-08-2024 The <a href="https://register.ema.europa.eu/identityiq/help/signin.html#mfasetup" target="_blank">Multi-Factor Authentication (MFA)</a> is active when logging in EudraCT. To access the website for the purpose of submitting <a href="multimedia_tutorials.html" target="_blank">results</a> or a <a href="docs/training/EudraCT user manual_Third country file submission.pdf" target="_blank">third country file</a>, users can <a href="https://eudract.ema.europa.eu/results-web/" target="_blank">log in EudraCT</a> using their EMA username followed by '@id.ema.europa.eu' and password, and proceed through <a href="https://register.ema.europa.eu/identityiq/help/signin.html#mfasetup" target="_blank">setting up their MFA</a>. Full instructions can be found <a href="docs/training/EudraCT user manual_EMA account creation.pdf" target="_blank">here</a>. In addition, users are no longer required to ask for a 'results user role', but can directly <a href="docs/training/EudraCT user manual_Primary user assignment.pdf" target="_blank">request the primary user assignment of trials</a>, when they need to post results for their trials. The <a href="docs/guidance/EudraCT FAQ_for publication.pdf" target="_blank">Frequently Asked Questions</a> have been updated accordingly. 24-07-2024 As of August 7th 2024, the Multi-Factor Authentication (MFA) will be active when logging in EudraCT. Users that need to submit <a href="multimedia_tutorials.html" target="_blank">results</a> or a <a href="docs/training/EudraCT user manual_Third country file submission.pdf" target="_blank">third country file</a>, will need to enable the MFA access on their EMA accounts, either installing the 'Microsoft Authenticator' app on their phones or using other authentication options. Further information <a href="https://register.ema.europa.eu/identityiq/help/signin.html#mfasetup" target="_blank">here</a>. 10-04-2024 Due to essential maintenance of SPOR, the EudraCT website will experience issues between 11th of April at 6 pm (CET) and15th of April at 6 pm (CET). During this timeframe, it will not be possible for users to upload CTA XML files to perform amendments to trial protocols. Users may also experience service losses in other parts of the website (e.g. results section). We apologise in advance for any inconvenience caused. 30-01-2024 As of 31 January 2025, all EU/EEA trials need to be conducted under <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536" target="_blank">Regulation (EU) 536/2014</a>. Any EU/EEA trial with a foreseen last patient last visit after this date is required to be transitioned to the <a href="https://euclinicaltrials.eu/">Clinical Trials Information System</a> as soon as possible: more information <a href="https://euclinicaltrials.eu/guidance-and-q-as/#qas-transitioning">here</a>. A new version of the <a href="docs/guidance/EudraCT FAQ_for publication.pdf">Frequently asked questions</a> is now available. Sponsors are encouraged to refer to it for questions on EudraCT/EU CTR, before submitting a query through our Service Now. 07-12-2023 A new version of the <a href="https://eudract-training.ema.europa.eu/" target="_blank">EudraCT results training environment</a> is now live. This version can be accessed by users who already have access to the EudraCT results application. However, a pre-registration for the training environment is still necessary: full instructions on how to access can be found <a href="docs/training/EudraCT user manual_Results training environment.pdf">here</a>. Please note that the old training environment credentials do not work in this new version, therefore it is not possible for users to retrieve old mock trials assigned in the old training environment. 1-08-2023 The option of posting a 'summary attachment' in the EudraCT results section is allowed in case: the trial never started, the trial terminated early, it is not possible to post a 'full data set' or in case the trial has transitioned to CTIS. The questions appearing after the sponsor clicks on 'post results' have now been updated accordingly. 31-05-2023 Due to essential maintenance, EudraCT and EU CTR websites will be briefly unavailable on 1st June, between 6 - 7 PM CEST. We apologize for this inconvenience and we thank you very much for your patience. 28-03-2023 The "Become a results user" functionality is not working as expected and as described in the <a href="https://eudract.ema.europa.eu/docs/training/EudraCT user manual_Results user role activation.pdf">relevant instructions</a>. Update24Apr2023: this issue is now solved. Due to essential maintenance, a planned downtime is foreseen for the EudraCT and EU CTR websites on Saturday, April 1st, between 8 am and 6 pm CET. We apologize for this inconvenience and we thank you very much for your patience. 23-02-2023 The EudraCT website has been affected by unexpected SPOR downtimes, which prevent users from performing usual functionalities, such as the uploading of an XML file. Update 24Feb2023: this issue is now solved; however, a few users have reported that they do not see their trials listed in 'your page', in order to post results. We encourage users to <a href="https://support.ema.europa.eu/esc" target="_blank">report this</a>, in case they are affected, to allow a better investigation and resolution by our IT. In addition, the EudraCT results training environment is currently not accessible: we will keep users updated on its accessibility through the present webpage. 10-02-2023 Users have reported issues with filling in section H of the EU/EEA CTA for protocol amendments and with the generation of EudraCT numbers for third country files. Our IT is currently working on this, we thank you very much for your patience. Update 14Feb2023: this issue is now solved. 06-02-2023 After implementing a system upgrade, on 02-02-2023 the EudraCT database experienced issues with results functionalities, which are now solved. We apologise for any inconvenience caused and we thank you for your patience. 31-01-2023 The Clinical Trial Regulation is now mandatory for all initial EU/EEA clinical trial applications. The EudraCT website has been amended accordingly. 15-12-2022 The EMA will be closed for public holidays until 03/01/2023 included. All requests submitted to the EudraCT team after 21/12/2022 will be processed from 04/01/2023. This includes <a href="https://eudract.ema.europa.eu/contact.html" target="_blank">Service Now queries</a>, emails to EudraCT_notification@ema.europa.eu and requests for assignments to trials for the purpose of posting results. We thank you for your understanding and we encourage you to refer to the <a href="https://eudract.ema.europa.eu/docs/guidance/EudraCT%20FAQ_for%20publication.pdf" target="_blank">Frequently Asked Questions</a> in the meantime. 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 <a href="https://eudract.ema.europa.eu/multimedia_tutorials.html" target="_blank">post</a> 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 <a href="https://support.ema.europa.eu/esc" target="_blank">https://support.ema.europa.eu/esc</a>. 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 <a href="https://www.ema.europa.eu/en/documents/other/faqs-transition-trials-eudract-ctis-ctis-training-programme-module-23_en.pdf" target="_blank">transition of trials to CTIS</a>, sponsors are encouraged to verify whether the correct status of their trials is reported on <a href="https://www.clinicaltrialsregister.eu/ctr-search/search" target="_blank">EU CTR</a>. An <a href="https://health.ec.europa.eu/system/files/2019-06/declaration_end_trial_form_0.pdf" target="_blank">end of trial form</a> 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 <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52012XC1006(01)" target="_blank">guideline 2012/C 302/03</a>: to know how to post results visit <a href="/multimedia_tutorials.html" target="_blank">Tutorials on posting results</a>. For questions, refer to <a href="/contact.html" target="_blank">Contact us</a>. 30-06-2022 Following the issuing of the <a href="https://eudract.ema.europa.eu/docs/guidance/1R%20-%20Joint%20letter%20signed%20by%20EC,%20EMA,%20HMA_en.pdf" target="_blank">Joint Letter by the European Commission, EMA and HMA</a>, National Competent Authorities and European Medicines Agency have sent reminders to sponsors who were not compliant with the <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52012XC1006(01)" target="_blank">European Commission guideline</a> 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 <a href="docs/List of trials.xlsx" target="_blank">here</a>. 03-03-2022 Following the European Commission's <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52012XC1006(01)" target="_blank">Guidance on results postings</a>, 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 <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52012XC1006(01)" target="_blank">Guidance on results postings</a> through looking for their sponsor name in <a href="https://www.clinicaltrialsregister.eu/ctr-search/search?query=" target="_blank">EU CTR</a>. To learn how to post results visit <a href="https://eudract.ema.europa.eu/multimedia_tutorials.html" target="_blank">Tutorials on posting results</a>.   Previous news can be found <a href="whatsnew_archive.html" target="_blank">here</a>   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. </td> </tr> <tr> <td class="line"></td> </tr> <tr> <td class="textBody"> </td> </tr> <tr> <td class="textBody"><table width="809"> <tr> <td width="345 style="vertical-align:top; padding-right:15px;"><img src="images/logo_emea.jpg" width="300" height="57" alt="EMA"></td> <td width="395" class="footer">Last Updated: August 09, 2024 12:00 A new version of the <a href="/docs/guidance/EudraCT FAQ_for publication.pdf" target="_blank">Frequently Asked Questions</a> is now available for users and more detailed instructions are now provided in the <a href="multimedia_tutorials.html" target="_blank">tutorials on posting results</a> European Medicines Agency © 1995-2024</td> </tr> </table></td> </tr> </table> </body> </html> <script id="f5_cspm">(function(){var f5_cspm={f5_p:'PKONHNGAMHGOMGHONALCEMKMEIBNEFOJKMPGLDNKPCAPKGNNJOJPJJAHIDDNANEIELKBIDICAACHLLFHDAAANGAEAAMJLJDLLOBMIDCDAOCKEAJNPBOIDCDHONEOLJON',setCharAt:function(str,index,chr){if(index>str.length-1)return str;return str.substr(0,index)+chr+str.substr(index+1);},get_byte:function(str,i){var s=(i/16)|0;i=(i&15);s=s*32;return((str.charCodeAt(i+16+s)-65)<<4)|(str.charCodeAt(i+s)-65);},set_byte:function(str,i,b){var s=(i/16)|0;i=(i&15);s=s*32;str=f5_cspm.setCharAt(str,(i+16+s),String.fromCharCode((b>>4)+65));str=f5_cspm.setCharAt(str,(i+s),String.fromCharCode((b&15)+65));return str;},set_latency:function(str,latency){latency=latency&0xffff;str=f5_cspm.set_byte(str,40,(latency>>8));str=f5_cspm.set_byte(str,41,(latency&0xff));str=f5_cspm.set_byte(str,35,2);return str;},wait_perf_data:function(){try{var wp=window.performance.timing;if(wp.loadEventEnd>0){var res=wp.loadEventEnd-wp.navigationStart;if(res<60001){var cookie_val=f5_cspm.set_latency(f5_cspm.f5_p,res);window.document.cookie='f5avr1377058531aaaaaaaaaaaaaaaa_cspm_='+encodeURIComponent(cookie_val)+';path=/;'+'';} return;}} catch(err){return;} setTimeout(f5_cspm.wait_perf_data,100);return;},go:function(){var chunk=window.document.cookie.split(/\s*;\s*/);for(var i=0;i<chunk.length;++i){var pair=chunk[i].split(/\s*=\s*/);if(pair[0]=='f5_cspm'&&pair[1]=='1234') {var d=new Date();d.setTime(d.getTime()-1000);window.document.cookie='f5_cspm=;expires='+d.toUTCString()+';path=/;'+';';setTimeout(f5_cspm.wait_perf_data,100);}}}} f5_cspm.go();}());</script>