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clinical Trials
<html> <head> <!DOCTYPE html> <html lang="en"> <title>clinical Trials</title> <meta charset="UTF-8"> <meta name="description" content="{{description}}"> <meta name="keywords" content="CDSCO, National Regulatory Authority"> <link rel="author" href="https://cdsco.gov.in/opencms/opencms/en/Home/" /> <meta name="description" content="he Central Drugs Standard Control Organisation(CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India."> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <script type="text/javascript" src="/opencms/export/system/modules/CDSCO.WEB/resources/js/jquery-3.7.1.min.js"></script> <link rel="stylesheet" type="text/css" href="/opencms/export/system/modules/CDSCO.WEB/resources/css/animate.min.css" /> <link rel="stylesheet" type="text/css" href="/opencms/export/system/modules/CDSCO.WEB/resources/css/owl.theme.css" /> <link rel="stylesheet" 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</script> </head> <body class="main_div1"> <div id="mainh"> <div id="wrapper"> <div class="container-fluid"> <header> <div class="row zeron"> <div class="col-md-12 col-sm-12 col-xs-12 header_top zero1"> <div id="cdsco_gigw" ><div> <div class="row justify-content-between"> <div class="col-md-3 col-xs-3 col-lg-3 col-sm-3" style="margin-top: 4px;"> <i class="fa fa-calendar fa-1x pad-right hidden-xs"></i><span id="date"></span> </div> <div class="col-md-8 col-xs-8 text-end head_links" style="margin-left: 6%;"> <a href="#section2" class="skip_mc white" title="Skip to main content" style="font-size: 20px;"><i class="fa fa-reply-all fa-rotate-270"></i></a> <!--<a href="#myNavbar" class="skipnv white">Skip to navigation</a>--> <a href="/opencms/opencms/en/ScreenReader/" class="white">Screen Reader</a> <!--<span class="theme"> <a href="#" class="white dark_bg">A</a> <a href="#" class="white light_bg">A</a> </span> --><span class="text_size"> Text Size <a href="#" class="white desc" 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bold;font-size:14px;">Directorate General of Health Services</h5> <h5 style="font-weight: bold;">Ministry of Health & Family Welfare</h5> <h5 style="font-weight: bold; color: rgb(99, 19, 19);">Government of India</h5> </div> <div class="col-md-1 col-sm-2 col-xs-3 zero text-right icdra_logo"> <!-- <a href="https://www.g20.org/en/" target="_blank"> <img src="/opencms/opencms/Image_folder/logo/g20.png" alt="g-20 logo" class="img-responsive" style="height:100px; margin-top: 25px"> </a> --> </div> <div class="col-md-2 col-sm-2 col-xs-3 zero text-right"> <a href="https://icdra2024.in/ICDRA/Homepage" target="_blank"> <img src="/opencms/export/sites/CDSCO_WEB/Image_folder/logo/icdra_logo_new1.png" alt="INTERNATIONAL CONFERENCE OF DRUG REGULATORY AUTHORITIES (ICDRA), INDIA-2024 logo" class="Icdra_Logo img-responsive" style="height:100px; margin-top: 15px; object-fit: contain;"> </a> </div> <div class="col-md-2 col-sm-2 col-xs-3 zero text-right swach_logo"> <a> <img 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class="text-decoration-none w-100" href="/opencms/opencms/en/About-us/" class="dropdown-toggle" data-toggle="dropdown" ><span class="fa-stacks fa-2s "> <i id="circle" class="fa fa-circle fa-2g "></i> <i class="fa fa-info-circle fa-1x fa-stack-1x bg-blue-head"></i> </span><p>About Us</p></a> <ul class="dropdown-menu "><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/About-us/Laboratories/" ><p>Central Drug Testing Laboratories</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/About-us/contact-us/" ><p>Contact Us</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/About-us/Functions/" ><p>Functions</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/About-us/Introduction/" ><p>Introduction</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/About-us/Seniority-List/" ><p>Seniority List</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/About-us/Telephone_Directory/" ><p>Telephone Directory</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/About-us/Values/" ><p>Values / Strategies</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/About-us/Vision/" ><p>Vision/Mission</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/About-us/who/" ><p>Who's who</p></a> </li></ul><li class="dropdown current-menu-item center"> <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/" class="dropdown-toggle" data-toggle="dropdown" ><span class="fa-stacks fa-2s "> <i id="circle" class="fa fa-circle fa-2g "></i> <i class="fa fa-gavel fa-1x fa-stack-1x bg-red-head"></i> </span><p>Act & Rules</p></a> <ul class="dropdown-menu "><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Drugs-and-Cosmetics-Act/" ><p>Drugs and Cosmetics Act, 1940</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Drugs-Rules/" ><p>Drugs Rules, 1945</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Medical-Devices-Rules/" ><p>Medical Devices Rules, 2017</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/New-Drugs/" ><p>New Drugs and Clinical Trials Rules, 2019</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Cosmetics-Rules/" ><p>Cosmetics Rules, 2020</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Advisories_NO/" ><p>Advisories/Notices/O.Ms./Orders</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Final-Notifications/" ><p>Final Notifications</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Draft-Notifications/" ><p>Draft Notifications </p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Guidance-documents/" ><p>Guidance documents</p></a> </li></ul><li class="dropdown current-menu-item center"> <a class="text-decoration-none w-100" href="/opencms/opencms/en/bioequi_bioavail/" class="dropdown-toggle" data-toggle="dropdown" ><span class="fa-stacks fa-2s "> <i id="circle" class="fa fa-circle fa-2g "></i> <i class="fa fa-hourglass 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href="/opencms/opencms/en/Clinical-Trial/" style="text-decoration:none">Clinical Trial</a></li> <li class="bold"><a href="/opencms/opencms/en/Clinical-Trial/clinical-trials/" style="text-decoration:none">Clinical Trials</a></li> </ul> </div> <div class=" col-md-2 col-lg-2 col-sm-12 col-xs-12"> <div class="pull-right"> <button type="button" class="print-gigw" onclick="printDiv('printableArea')" value="print a div!" /><i class="fa fa-print" aria-hidden="true"></i></div> </div> </div> </div> <script> function printDiv(printableArea) { var printContents = document.getElementById(printableArea).innerHTML; var originalContents = document.body.innerHTML; document.body.innerHTML = printContents; window.print(); document.body.innerHTML = originalContents; } </script></div> <section id="printableArea"> <div class="row pad-top text-center"> <div id="maintitle" ><div class="none"> <div > <div ><h2 class="blue bold" style="text-align: center; font-size: 25px;"><span class="maintitle">Clinical 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src="/opencms/export/system/modules/CDSCO.WEB/resources/img/slider/clinical_sub.jpg" alt="Hero Banner Images" /></a> </div> <!-- item --> </div> <!-- carousel-inner --> <a class="opacity-100 carousel-control-prev" data-bs-slide="prev" data-bs-target="#transition-timer-carousel"> <span class="carousel-control-prev-icon"></span> </a> <a class="opacity-100 right carousel-control-next" data-bs-slide="next" data-bs-target="#transition-timer-carousel"> <span class="carousel-control-next-icon"></span> </a> <hr class="transition-timer-carousel-progress-bar animate" /> </div> <!-- transition-timer-carousel --> </div> <!-- main-slider --> </div></div> <div class="col-md-4 col-sm-12 col-xs-12"> <div class="inner-right-all"> <div id="cdsco_tab-stacked-med" ><div class="margin-bottom-30"> <div class="panel-group wrap" id="bs-collapse639ed200-be60-11e7-b486-0a0027000000"> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark active" data-bs-toggle="collapse" data-bs-parent="#bs-collapse639ed200-be60-11e7-b486-0a0027000000" href="#collapse639ed200-be60-11e7-b486-0a0027000000-1"> About Clinical Trial<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse639ed200-be60-11e7-b486-0a0027000000-1" class="panel-collapse collapse " style="height: auto;" data-bs-parent="#bs-collapse639ed200-be60-11e7-b486-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><p>Content not Available</p> <p> </p></div> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse639ed200-be60-11e7-b486-0a0027000000" href="#collapse639ed200-be60-11e7-b486-0a0027000000-2"> Functionalities<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse639ed200-be60-11e7-b486-0a0027000000-2" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse639ed200-be60-11e7-b486-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><p>Content not Available</p></div> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse639ed200-be60-11e7-b486-0a0027000000" href="#collapse639ed200-be60-11e7-b486-0a0027000000-3"> Processes<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse639ed200-be60-11e7-b486-0a0027000000-3" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse639ed200-be60-11e7-b486-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><p><a style="color: black; text-decoration: uderline;" title=" GCT Processes" href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/GCT_PDFs/Approval_process_flowchart_GCT_Online.pdf" target="_blank" rel="noopener noreferrer"> GCT Processes<em class="fa fa-file-pdf-o" aria-hidden="true"> </em> </a></p></div> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse639ed200-be60-11e7-b486-0a0027000000" href="#collapse639ed200-be60-11e7-b486-0a0027000000-4"> Organogram<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse639ed200-be60-11e7-b486-0a0027000000-4" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse639ed200-be60-11e7-b486-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="margin-bottom-20"> <div class=""> <span > <img src="/opencms/export/sites/CDSCO_WEB/Image_folder/GCT_organo.png" class=" img-responsive " alt="New image" title="New image " /> </span> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse639ed200-be60-11e7-b486-0a0027000000" href="#collapse639ed200-be60-11e7-b486-0a0027000000-5"> Guideline<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse639ed200-be60-11e7-b486-0a0027000000-5" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse639ed200-be60-11e7-b486-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><div class="panel-body"> <p> </p> <ul id="guide" class="guidelines"> <li style="text-align: justify;"><strong><a style="color: black; text-decoration: none;" title="Sugam User Manual" href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/SUGAM_user_manual.pdf" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/UserguidePNG30x30.png" alt="UserguidePNG(30x30)" /> Sugam User Manual</a></strong></li> <li style="text-align: justify;"><strong><a style="color: black; text-decoration: none;" title="FAQ" href="http://cdsco.nic.in/forms/list.aspx?lid=1812&Id=1" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/faq_icon30x30.png" alt="faq_icon(30x30)" /> FAQ</a></strong></li> <li style="text-align: justify;"><strong><a style="color: black; text-decoration: none;" title="Standard Operating Process" href="http://cdsco.nic.in/forms/list.aspx?lid=1812&Id=1" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/gears30x30.png" alt="gears(30x30)" /> Standard Operating Process</a></strong></li> <li style="text-align: justify;"><strong><a style="color: black; text-decoration: none;" title="Tutorials" href="http://cdsco.nic.in/forms/list.aspx?lid=1812&Id=1" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/icon-tut30x30.png" alt="icon-tut(30x30)" /> Tutorials</a></strong></li> <li style="text-align: justify;"><strong><a style="color: black; text-decoration: none;" title="Chechlist Document" href="#" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/iStock30x30.jpg" alt="iStock(30x30)" /> Checklist Documents</a></strong></li> </ul> </div></div> </div> </div> </div></div> </div> </div> </div> </div> </div></div> </div> </div> <!-- main_sec --> <div class="row section3 "> <div class="col-md-12 section3_medical"> <!-- <div class="col-md-4 col-sm-12 col-xs-12 pad-top double">--> <!-- <html> <head> <style> ul { list-style-type: none; } li{ list-style-type: none; padding-top:3px; } </style> </head> <body> <div class="panel panel-default "> <div class="panel-heading bold "> <h5> <i class="fa fa-exclamation-triangle fa-2x pad-right half css_blink"></i>Alerts </h5> </div> <div class="panel-body "> <ul> <marquee behavior="scroll" direction="up" scrollamount="3" onmouseover="this.stop();" onmouseout="this.start();"> <li><i class="fa fa fa-hand-o-right" style="color: red"></i> <a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTI='> <span class="font_black">GCP Inspection Checklist16</span><i class="fa fa-file-pdf-o" style="color: red"></i><span class="date_blue"> 2018-Feb-09</span></a> </li> </marquee> </ul> </div> </div> </body> </html> --> <!--</div> --> <div class="col-md-12 col-sm-12 col-xs-12 pad-top double" id="med_nav"> <!DOCTYPE html> <html lang="en"> <head> <style> ul { list-style-type: none; } li{ list-style-type: none; padding-top:3px; } </style> <script> $(document).ready(function() { $(".btn-pref .btn").click(function () { $(".btn-pref .btn").removeClass("btn-primary").addClass("btn-default"); // $(".tab").addClass("active"); // instead of this do the below $(this).removeClass("btn-default").addClass("btn-primary"); }); }); </script> <div class="col-lg-12 col-sm-12"> <ul class="btn-pref nav nav-tabs" id="myTab" role="tablist"> <li class="nav-item" role="presentation"> <button type="button" id="alerts" class="w-100 active btn btn-primary" data-bs-target="#tab1" data-bs-toggle="tab" aria-selected="true" aria-controls="#tab1"><i class="fa fa-exclamation-triangle"></i> <div class="hidden-xs">Alerts</div> </button> </li> <li class="nav-item" role="presentation"> <button type="button" id="news" class="w-100 btn btn-default" data-bs-target="#tab2" data-bs-toggle="tab" aria-selected="false" aria-controls="#tab2"><i class="fa fa-newspaper-o"></i> <div class="hidden-xs">News</div> </button> </li> <li class="nav-item" role="presentation"> <button type="button" id="notices" class="w-100 btn btn-default" data-bs-target="#tab3" data-bs-toggle="tab" aria-selected="false" aria-controls="#tab3"><i class="fa fa-file-text"></i> <div class="hidden-xs">Public Notices</div> </button> </li> <li class="nav-item" role="presentation"> <button type="button" id="gazette" class="w-100 btn btn-default" data-bs-target="#tab4" data-bs-toggle="tab" aria-selected="false" aria-controls="#tab4"><i class="fa fa-bell"></i> <div class="hidden-xs">Gazette Notifications</div> </button> </li> </ul> <div class="tab-content"> <div class="tab-pane fade show active" id="tab1"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>GCP Inspection Checklist16</td> <td>2018-Feb-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTI='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>261kb</td> </tr> </tbody> </table> </div> </div> </div> <div class="tab-pane fade" id="tab2"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example1" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example1"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>Submission of PSUR</td> <td>2018-Feb-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTM='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>529kb</td> </tr> <tr> <td>2</td> <td>System of Pre-screening for submission of reports of SAEs to CDSCO</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM5OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>255 KB</td> </tr> <tr> <td>3</td> <td>Draft Guidance For Industry On Requirement Of Chemical & Pharmaceutical Information Including Stability Study Data Before Approval Of Clinical Trials / BE Studies</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM5Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>2599 KB</td> </tr> <tr> <td>4</td> <td>Formula to Determine the quantum of compensation in the cases of Clinical Trial related serious Adverse Events(SAEs) of Deaths Occuring During Clinical Trials</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM4Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>310 KB</td> </tr> <tr> <td>5</td> <td>Panel of Experts for examination of reports of Serious Adverse Events (SAEs) of Deaths</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzQwMA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>667 KB</td> </tr> <tr> <td>6</td> <td>System for the Pre - Screening of the applications for registration of Ethics Committee</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM5OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>206 KB</td> </tr> <tr> <td>7</td> <td>Monitoring of Clinical Trials - regarding</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM5MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>397 KB</td> </tr> <tr> <td>8</td> <td>GCP inspection Checklist</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM4NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>261 KB</td> </tr> <tr> <td>9</td> <td>Good Clinical Practice Guidelines</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM5NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1074 KB</td> </tr> <tr> <td>10</td> <td>Formula to Determine the quantum of compensation in the cases of Clinical Trial related serious Adverse Events(SAEs) of Injury other than Deaths Occuring During Clinical Trials</td> <td>2014-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM4NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>368 KB</td> </tr> <tr> <td>11</td> <td>Draft Guidelines on Audio-Visual Recording of Informed Consent Process In Clinical Trial</td> <td>2014-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM4OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>434 KB</td> </tr> <tr> <td>12</td> <td>DCG(I) approved Clinical Trial registered in Clinical Trial Jan 2013</td> <td>2013-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM5Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>99 KB</td> </tr> <tr> <td>13</td> <td>Registration of Clinical Trials ( 26 Jul 2012 )</td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM4Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>369 KB</td> </tr> <tr> <td>14</td> <td>New Drugs Recommended by NDAC for marketing authorization in India without Local Clinical Trial (Till August 2012)</td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM5NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>166 KB</td> </tr> <tr> <td>15</td> <td>Guidance on Clinical Trial Inspection ( 26 Jul 2012 )</td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM4Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>492 KB</td> </tr> <tr> <td>16</td> <td>Details of Global Clinical trial approved in 2012</td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM5MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>926 KB</td> </tr> </tbody> </table> </div> </div> </div> <div class="tab-pane fade" id="tab3"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example2" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example2"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>Draft Guidelines on Good Clinical Practices</td> <td>2024-Sep-12</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTE4OTU='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>3315 KB</td> </tr> <tr> <td>2</td> <td>Notice regarding conduct on clinicl trial in present situation due to outbrea of COVID-19</td> <td>2020-Mar-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjM2Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>602 KB</td> </tr> <tr> <td>3</td> <td>List of approved Clinical Trial Sites and Investigators</td> <td>2019-Dec-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTM2NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1932 KB</td> </tr> <tr> <td>4</td> <td>List of approved Clinical Trial Sites & Investigators for Global Clinical Trials</td> <td>2019-Dec-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTM2Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>347 KB</td> </tr> <tr> <td>5</td> <td>Notice regarding human vacine appliation through SUGAM online Portal of CDSCO</td> <td>2017-Dec-26</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDM2'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>584KB</td> </tr> <tr> <td>6</td> <td>Notice Order regarding SUGAM ONLINE Dated 01.12.2016 </td> <td>2016-Nov-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTA1'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>260KB</td> </tr> <tr> <td>7</td> <td>Notice Order regarding SUGAM ONLINE</td> <td>2016-Oct-05</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTE2'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>259KB</td> </tr> <tr> <td>8</td> <td>Notice for Online Clinical Trial Application and Monitoring System (OCTAMS)</td> <td>2015-Sep-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjM2'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>52KB</td> </tr> <tr> <td>9</td> <td>Office Order dated 05.09.2014 reg. Information required in respect of Conduct of the Clinical Trial of New Drugs and GCT in India</td> <td>2014-Sep-05</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzA4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>503KB</td> </tr> <tr> <td>10</td> <td>Notice 28.07.2014 PROPOSAL FOR CREATION OF IT ENABLED SYSTEM</td> <td>2014-Jul-28</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzEz'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>210KB</td> </tr> <tr> <td>11</td> <td>Office Order dated 03.07.2014 -Limiting number of CT an Investigator can undertake at a time </td> <td>2014-Jul-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzE4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>158KB</td> </tr> <tr> <td>12</td> <td>Office Order dated 03.07.2014 - Waiver of CT in Indian Population for approval of New Drugs </td> <td>2014-Jul-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzI0'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>152KB</td> </tr> <tr> <td>13</td> <td>Office Order dated 03.07.2014 - Providing Ancillary Care to the Clinical Trial subjects</td> <td>2014-Jul-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzIx'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>156KB</td> </tr> <tr> <td>14</td> <td>Office Order dated 03.07.2014 - Placebo Controlled Trials</td> <td>2014-Jul-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzI4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>174KB</td> </tr> <tr> <td>15</td> <td>Office Order dated 03.07.2014 - Approval of academic CT</td> <td>2014-Jul-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzIy'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>146KB</td> </tr> <tr> <td>16</td> <td>Office Order dated 03.07.2014 - Clinical Trial on Medical Device</td> <td>2014-Jul-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzE5'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>164KB</td> </tr> <tr> <td>17</td> <td>Office Order dated 03.07.2014 - CT Compensation in case of injury or death discerned at a later stage</td> <td>2014-Jul-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzIw'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>164KB</td> </tr> <tr> <td>18</td> <td>Office Order dated 03.07.2014 - Number of subjects in Phase III Global CT</td> <td>2014-Jul-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzI3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>151KB</td> </tr> <tr> <td>19</td> <td>PROPOSAL FOR CREATION OF IT ENABLED SYSTEM</td> <td>2014-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM4Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>211 KB</td> </tr> <tr> <td>20</td> <td>Audio -Video Recording of Informed Consent Process of All New Subjects in Clinical Trials- Administrative Orders Monitoring of Clinical Trials - regarding</td> <td>2013-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM4OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>733 KB</td> </tr> <tr> <td>21</td> <td>Order Dated 06.02.2013: "System for supervision Clinical trials on new Chemical entities in the light of direction of Hon'ble Supreme Court of India"</td> <td>2013-Feb-06</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODA4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>739KB</td> </tr> <tr> <td>22</td> <td>Notice-dated 11.12.2012: Advisory notice on Clinical Trial</td> <td>2012-Dec-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODE0'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1,240Kb</td> </tr> <tr> <td>23</td> <td>Office Memo.-dated 29.08.2012: Expert committee for finalization of Schedule Y1 (CRO Registration)</td> <td>2012-Aug-29</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODMy'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>297KB</td> </tr> <tr> <td>24</td> <td>Notice: Expansion of panel of experts for evaluation of applications of New Drugs, Clinical Trials and Medical Devices </td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM5Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1292 KB</td> </tr> <tr> <td>25</td> <td>Advisory notice on clinical trial </td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM5Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1273 KB</td> </tr> </tbody> </table> </div> </div> </div> <div class="tab-pane fade" id="tab4"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example3" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example3"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>G.S.R.227(E) 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