EU Clinical Trials Register

<!DOCTYPE html> <html xmlns="http://www.w3.org/1999/xhtml"> <head> <meta http-equiv="Content-Type" content="text/html; charset=utf-8" /> <meta name="description" content="The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area." /> <script type="text/javascript" src="js/common_functions.js"></script> <title>EU Clinical Trials Register - Data quality</title> <link href="css/960.css" rel="stylesheet" type="text/css"> <link href="css/reset.css" rel="stylesheet" type="text/css"> <link href="css/text.css" rel="stylesheet" type="text/css"> <link href="css/styles.css" rel="stylesheet" type="text/css"> <link href="css/nav.css" rel="stylesheet" type="text/css"> <script type="text/javascript"> sfHover = function() { var sfEls = document.getElementById("nav").getElementsByTagName("LI"); for (var i=0; i<sfEls.length; i++) { sfEls[i].onmouseover=function() { this.className+=" sfhover"; } sfEls[i].onmouseout=function() { this.className=this.className.replace(new RegExp(" sfhover\\b"), ""); } } } if (window.attachEvent) window.attachEvent("onload", sfHover); </script> </head> <body onload="javascript:populateCurrentYear();"> <div id="headerContainer" class="width100"> <table id="logoContainer" class="container_12"> <tbody><tr> <td width="55"> <img alt="Flag of the European Union" height="53" src="img/euFlag.png" > </td> <td width="586" > <span class="bannerText" >EU Clinical Trials Register</span></td> <td width="307" ><span class="headernav"><a href="help.html">Help</a></span></td> </tr> </tbody></table> <table id="mainMenuContainer" class="container_12"> <tbody><tr> <td> <ul id="nav" class="mainMenu width100 margin0"> <li class="underL"> <a title="EU Clinical Trials Register home page" href="/ctr-search/search">Home & Search</a> </li> <li class="underL"> <a title="Click to view Joining a Clinical Trial page" href="joiningtrial.html">Joining a trial</a> </li> <li class="underL"> <a title="Click to view the EU Clinical Trials Register Contacts page" href="contacts.html">Contacts</a> </li> <li class="selected underL"> <a title="About" href="about.html">About</a> <ul style="width: 250px;"> <li><a href="about.html">About the EU Clinical Trials Register</a></li> <li><a href="whatsNew.html">What's new</a></li> <li><a href="dataquality.html">Data quality</a></li> <li><a href="ctsponsors.html">Clinical trial sponsors</a></li> <li><a href="natauthorities.html">National medicine regulatory authorities</a></li> <li><a href="links.html">Links</a></li> </ul> </li> <li class="underL"> <a title="Click to view Joining a Clinical Trial page" href="index.html">News update</a> </li> </ul> </td> </tr> </tbody> </table> </div> <div class="container_12"> <div class="grid_8 marginB12"> <h1>Data quality</h1> <p>The national competent authorities and the European Medicines Agency are working together to ensure the completeness of the records including the review by the competent authority or ethics committee in the country concerned and the end of trial. </p> <h2>Data quality of historical information</h2> <p><strong>Data quality from 10 March 2011 for protocol related information</strong></p> <p>The 10th March 2011 launch of version 8.0 of the EudraCT database has put in place a more comprehensive set of validation rules for data entry to ensure greater data completeness and consistency. National medicine regulatory authorities and the European Medicines Agency are also working to ensure timely entry of information.</p> <p> Version 8.0 of the EudraCT database includes enhanced automated checking and quality control and the increased use of standardised data.</p> <p>The data quality initiative includes requirements such as:</p> <ul> <li>the completion of all relevant fields;</li> <li>the entry of data in a timely manner;</li> <li>the use of drop-down lists rather than free text, wherever possible. </li> </ul> </div> <div class="grid_3 columnContainer" style="float:right"> <h3>Version of the website</h3> <p>EU Clinical Trials Register version 2.2</p> <p> </p> <h3>See also:</h3> <p><a href="doc/EU_Clinical_Trials_Register_Glossary.pdf" class="pdfIco" target="_blank">Glossary</a> <img src="img/icon_pdf_small.gif" width="17" height="17" alt="PDF document"></p> <p><a href="doc/How_to_Search_EU_CTR.pdf" class="pdfIco" target="_blank">How to search</a> <img src="img/icon_pdf_small.gif" width="17" height="17" alt="PDF document"></p> <p><a href="doc/EU_CTR_FAQ.pdf" class="pdfIco" target="_blank">FAQs</a> <img src="img/icon_pdf_small.gif" width="17" height="17" alt="PDF document"></p> <p><a href="https://www.ema.europa.eu/en/partners-networks/patients-consumers" target="_blank">Patients’ and Consumers’ Organisations’ contact information</a></p> <p><a href="https://www.ema.europa.eu/en/partners-networks/healthcare-professionals/eligible-healthcare-professionals-organisations" target="_blank">Healthcare Professionals’ Organisations contact information</a></p> <p><a href="doc/Sponsor_Contact_Information_EUCTR.pdf" class="pdfIco" target="_blank">Sponsors' contact information</a> <img src="img/icon_pdf_small.gif" width="17" height="17" alt="PDF document"></p> </div> </div> <div id="footerContainer" class="width100"> <div class="container_12" id="footerMenuContainer"> <p><span class="leftFooter"> For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in <br> the Protocol on Ireland / NI. <br><br> For support, please <a href="https://eudract.ema.europa.eu/contact.html" target="_blank">Contact us</a>. <br><br> European Medicines Agency © 1995-2024 I Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands </span></p> <p> <span class="rightFooter"> <a class="whitefooterlink controls" href="disclaimer.html"> Legal notice </a> </span></p> </div> </div> <div id="finalContainer" class="width100"> <div class="container_12"> <img src="img/footerLogos.png" width="960" height="48" alt="EMA and HMA"> </div> </div> </body> </html> <script id="f5_cspm">(function(){var f5_cspm={f5_p:'OIBPMAPPNIIJJMGKFCFGGPPBGCFIKLPMKNAFCEHHLHACAFKCBDHKGJJHJOJODDGLJMCBMPIHAAONKAHAALBAKBMCAAPECOBAKIGFKJOLHHNHNHFAPNIMOIHDDLCGOJMI',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>

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EU Clinical Trials Register - Data quality