EudraCT Public Protocol Documentation page

<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"> <html> <head> <title>EudraCT Public Protocol Documentation 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"/> <style type="text/css">  </style> </head> <body>  <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>   <table width="1083" style="margin-left:225px; margin-right:145px;"> <tr> </td> </tr> <td height="21" class="textBody"><h1 class="simpleLabelBold">EudraCT step-by-step guide</h1> </td> <tr> <td class="line"></td> </tr> <tr> <td bgcolor="#F3F3F3" class="textBody"><h3>For a trial conducted in the European Economic Area:</h3> As of 31 January 2023, all initial trial applications in the European Union (EU)/European Economic Area (EEA) must be submitted through <a href="https://euclinicaltrials.eu/" target="_blank">CTIS</a>. In case a new EU/EEA-country needs to be added to a EudraCT trial, the EudraCT trial needs to be <a href="docs/guidance/faqs-transition-trials-eudract-ctis-ctis-training-programme-module-23_en.pdf" target="_blank">transitioned to CTIS</a> first: see <a href="https://health.ec.europa.eu/system/files/2023-07/transition_ct_dir-reg_guidance_en.pdf">Guidance for the Transition of clinical trials</a>. The procedure below is applicable to all EudraCT Clinical Trial Applications that were submitted to EU/EEA National Competent Authorities (NCAs) before January 31st, 2023. Sponsor, if an amendment to a EudraCT CTA is needed: <ol start="1" type="1"> <li class="textBody"><a href="https://eudract.ema.europa.eu/docs/training/EudraCT user manual_filling in CTA_3rd country file.pdf" target="_blank">Uploads, amends and validates the XML file of each EU/EEA Clinical Trial Application (CTA)</a> of the EudraCT trial that needs to be amended </a>In order to save the CTA while completing it, the Sponsor needs to download it (click on “Save as XML”). In order to go on with its completion, the Sponsor needs to upload it again (the EudraCT application is only a tool for amending a CTA, the Sponsor is not logged in the website).</li> </ol> <ol start="2" type="1"> <li class="textBody"><a href="https://eudract.ema.europa.eu/docs/training/EudraCT user manual_Package creation and other functionalities.pdf" target="_blank">Provides CTA package</a> to <a href="/nca_contacts.html" target="_blank">National Competent Authority(ies)</a> The XML file needs to be validated, saved and provided to every national competent authority that had authorised the trial. </li> </ol> Each National Competent Authority, if receiving a EudraCT CTA amendment from a sponsor: <ol start="3" type="1"> <li class="textBody">Verifies that the initial CTA XML file of the trial is already uploaded for their member state, assesses and loads the CTA amendment in EudraCT </li> </ol> <ol start="4" type="1"> <li class="textBody">Verifies that NCA and Ethics Committee approval dates are inserted The trial is public on <a href="https://www.clinicaltrialsregister.eu/ctr-search/search" target="_blank">EU CTR</a>, with the exception of phase 1 trials conducted solely on adults, see <a href="docs/guidance/EudraCT FAQ_for publication.pdf" target="_blank">Frequently Asked Questions</a> </li> </ol> Sponsor, once the trial has ended: <ol start="5" type="1"> <li class="textBody">Sends the <a href="https://health.ec.europa.eu/system/files/2019-06/declaration_end_trial_form_0.pdf" target="_blank">Declaration of End of Trial (EoT)</a> form to <a href="/nca_contacts.html" target="_blank">NCA(s)</a> In case the trial never started or was ended prematurely, the Sponsor should specify that the trial has “Prematurely ended”</li> </ol> Each National Competent Authority, after receiving the End of Trial form: <ol start="6" type="1"> <li class="textBody">Sets the trial status as “completed” (or “prematurely ended”) in the EudraCT Secure website The trial status is updated on <a href="https://www.clinicaltrialsregister.eu/ctr-search/search" target="_blank">EU CTR</a></li> </ol> Sponsor, within 1 year from EoT date (or within 6 months for paediatric trials): <ol start="7" type="1"> <li class="textBody"><a href="https://eudract.ema.europa.eu/results-web/" target="_blank">Posts results</a> on EudraCT following the <a href="/multimedia_tutorials.html" target="_blank">Tutorials on posting results</a> Results appear on <a href="https://www.clinicaltrialsregister.eu/ctr-search/search" target="_blank">EU CTR</a> two weeks after posting date</li> </ol> Further details on the process are provided in our <a href="docs/guidance/EudraCT FAQ_for publication.pdf" target="_blank">Frequently Asked Questions</a> <h3>For a trial to be conducted exclusively outside of the EEA, but part of a PIP/Art 46 of the paediatric regulation:</h3> The below is applicable to trials that are conducted exclusively outside of the EU/EEA but, that are part of a Paediatric Investigation Plan and/or in scope of Art 46 of the paediatric regulation (EC) No 1901/2006 (“third country files”). For PIP/Art 46 trials that will be conducted in the EU/EEA as well as outside of the EU/EEA, the initial submission must be performed solely through <a href="https://euclinicaltrials.eu/" target="_blank">CTIS</a>. Sponsor (third country data provider): <ol start="1" type="1"> <li class="textBody"><a href="docs/training/EudraCT user manual_EudraCT number generation.pdf" target="_blank">Requests EudraCT number </a>Sponsor is advised to take a screenshot of the EudraCT number assigned, in case the confirmation email is not received</li> </ol> <ol start="2" type="1"> <li class="textBody"><a href="docs/training/EudraCT user manual_filling in CTA_3rd country file.pdf" target="_blank">Creates, fills in, validates and saves the Third country XML file</a> using EudraCT application In order to save the third country file while completing it, the Sponsor needs to download it (click on “Save as XML”). In order to go on with its completion, the Sponsor needs to upload it again (the EudraCT application is only a tool for creating a CTA, the Sponsor is not logged in to the website). At the end of its completion, the XML file needs to be validated and saved.</li> </ol> <ol start="3" type="1"> <li class="textBody">Sets up an <a href="docs/training/EudraCT user manual_EMA account creation.pdf" target="_blank">EMA account</a>, requests a <a href="docs/training/EudraCT user manual_Third country file submission.pdf" target="_blank">“EudraCT third country data provider” role</a> through the <a href="https://support.ema.europa.eu/esc" target="_blank">Service Now</a> See details in our <a href="docs/guidance/EudraCT FAQ_for publication.pdf" target="_blank">Frequently Asked Questions</a>. To know how to log in Service Now, see <a href="/contact.html" target="_blank">Contact us</a></li> </ol> <ol start="4" type="1"> <li class="textBody"><a href="https://eudract.ema.europa.eu/results-web/" target="_blank">Logs in EudraCT</a> website and <a href="docs/training/EudraCT user manual_Third country file submission.pdf" target="_blank">submits the third country XML file</a> The trial is now public on <a href="https://www.clinicaltrialsregister.eu/ctr-search/search" target="_blank">EU CTR</a></li> </ol> Within 6 months from End of Trial date: <ol start="5" type="1"> <li><a href="https://eudract.ema.europa.eu/results-web/" target="_blank">Posts results</a> on EudraCT following the <a href="/multimedia_tutorials.html" target="_blank">Tutorials on posting results</a> </a>Results appear in <a href="https://www.clinicaltrialsregister.eu/ctr-search/search" target="_blank">EU CTR</a> two weeks after posting date</li> </ol> Further details on the process are provided in our <a href="docs/guidance/EudraCT FAQ_for publication.pdf" target="_blank">Frequently Asked Questions</a><h2> </h2></td> </tr> <td class="line"></td> </tr> <tr> <td class="textBody"><table width="809"> <tr> <td width="359" style="vertical-align:top; padding-right:15px;"><img src="images/logo_emea.jpg" width="300" height="57" alt="EMA"></td> <td width="438" class="footer">Last Updated: August 01, 2023 12:00 European Medicines Agency © 1995-2024 </td> </tr> </tr> </table></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? 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EudraCT Public Protocol Documentation page