EudraCT Public Website Training page

<!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"> <html> <head> <title>EudraCT Public Website Training 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="1" cellpadding="1"> <tr width="100%"> <td id="rowTop1"align="left"><img src="images/eudractlefthead.png"/></td> <td id="rowTop2" align="right" > </td> </tr>   <tr width="100%"> <td align="left" id="rowBottom1"> </td> <td align="right" id="rowBottom2" ><span class="textBody" style="vertical-align:top; padding-right:15px;">Hosted on behalf of the European Commission</span><a href="http://ec.europa.eu/index_en.htm" title="European Commission" target="_blank"><strong><span style="vertical-align:top; padding-right:15px;"><img src="images/smalleuflag.gif" width="30" height="20" alt="EU"></span></strong></a></td> </tr> </table> </td> </tr> </table>   <table width="1043" style="margin-left:225px; margin-right:145px;"> <tr> <td bgcolor="#FFFFFF" class="textbody"><h1><span class="simpleLabelBold">EudraCT user manual and training</span></h1></td> </tr> <td class="line"> </td> <tr> <td bgcolor="#F3F3F3" class="textbody"><h2><span class="simpleLabelBold">User manual</span></h2> <span class="textBody">The below specific instructions are linked in the <a href="protocol.html" target="_blank">EudraCT step-by-step guide</a> and in the <a href="multimedia_tutorials.html" target="_blank">Tutorials on posting results</a>. <br><br> <em>Instructions on how to perform amendments to EudraCT EU/EEA Clinical Trial Applications that were submitted before 31 January 2023:</em></span> <ul> <li class="textBody"><a href="docs/training/EudraCT user manual_filling in CTA_3rd country file.pdf" target="_blank">Uploading, amending, validating, and saving a EudraCT EU/EEA Clinical Trial Application </a></li> <li class="textBody"><a href="docs/training/EudraCT user manual_Package creation and other functionalities.pdf" target="_blank">Submission package and other functionalities</a></li> </ul> <br> <em>Instructions on creation and EudraCT submission of a third country file for a trial conducted <u>exclusively</u> outside of the EU/EEA, but part of a Paediatric Investigation Plan (PIP) and/or conducted under art 46 of the paediatric Regulation (EC) No 1901/2006:</em></span> <ul> <li class="textBody"><a href="docs/training/EudraCT user manual_EudraCT number generation.pdf" target="_blank">Requesting a EudraCT number</a></li> <li class="textBody"><a href="docs/training/EudraCT user manual_filling in CTA_3rd country file.pdf" target="_blank">Creating, filling-in, saving, loading, and validating a Third country file</a></li> <li class="textBody"><a href="docs/training/EudraCT user manual_Third country file submission.pdf" target="_blank" class="textBody">Requesting a third country data provider user role and uploading the third country file on EudraCT</a></li> </ul> <br> <em>Instructions applicable to users that would like to post results for their EudraCT trials:</em></span> <ul> <li class="textBody"><a href="docs/training/EudraCT user manual_EMA account creation.pdf" target="_blank">Creation of an EMA account</a></li> <li class="textBody"><a href="docs/training/EudraCT user manual_Primary user assignment.pdf" target="_blank" class="textBody">Assignment of a trial as primary user</a></li> <li class="textBody"><a href="docs/training/EudraCT user manual_Delegation for results.pdf" target="_blank" class="textBody">Delegation of results to back-up user, delegated preparers and posters</a></li> <li class="textBody"><a href="docs/training/EudraCT user manual_Results full data set validation.pdf" target="_blank" class="textBody">Validating the results full data set</a></li> <li class="textBody"><a href="docs/training/EudraCT user manual_Results posting.pdf" target="_blank" class="textBody">Posting of results</a> (and <a href="docs/training/EudraCT user manual_Results updating after posting.pdf" target="_blank" class="textBody">updating them</a> after posting, if needed)</li> </ul> <h2><span class="simpleLabelBold">Results Training environment</span></h2> <span class="textBody">The training environment is aimed at representatives of sponsors who wish to practice results posting and get a better understanding of the preparation and posting of their trials' results on EudraCT:</span> <ul> <li class="textBody"><a href="https://eudract-training.ema.europa.eu/" target="_blank">EudraCT Results Training environment </a></li> <li class="textBody">Instructions on how to <a href="docs/training/EudraCT user manual_Results training environment.pdf">create an account for this environment and assign yourself a mock trial</a></li> <li class="textBody"><a href="multimedia_tutorials.html" target="_blank" class="textBody">Tutorials on posting results</a></li> </u> <br> EudraCT archived training can be found <a href="archived_training.html">here</a></td> </tr> <tr> <td class="line"> </td> </tr> <tr> <td class="textBody"><table width="809"> <tr> <td width="300" style="vertical-align:top; padding-right:15px;"><img src="images/logo_emea.jpg" width="300" height="57" alt="EMA"></td> <td width="384" class="footer"><strong>Last Updated:</strong> August 09, 2024 12:00<br/> European Medicines Agency 漏 1995-2024<br/></td> </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"><p><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 Website Training page