{"id":384,"date":"2019-01-17T08:43:15","date_gmt":"2019-01-17T08:43:15","guid":{"rendered":"http:\/\/206.71.52.87\/~newwebproject\/?page_id=384"},"modified":"2019-08-09T10:21:50","modified_gmt":"2019-08-09T10:21:50","slug":"randomisation-system-development-and-user-acceptance-testing","status":"publish","type":"page","link":"https:\/\/cdsatoolkit.thsti.in\/?page_id=384","title":{"rendered":"Randomisation System Development and User Acceptance Testing"},"content":{"rendered":"<div class=\"flex_column av_two_fifth  flex_column_div first  \" style='padding:0px px 0px -15px ; border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><div class=\"dfr1\" style=\"text-align: left;\"><strong>Clinical Trials Toolkit &#8211; India<\/strong><\/div>\n<\/div><\/section><\/div>\n<div class=\"flex_column av_three_fifth  flex_column_div   \" style='padding:0px 0px 10px 0px ; border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><div class=\"dfr\" style=\"text-align: right;\"><strong><strong>You are in: Home \/ Routemap \/ <\/strong>Randomization System Development and User Acceptance Testing<\/strong><\/div>\n<\/div><\/section><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='sdew' class='avia-section main_color avia-section-default avia-no-shadow avia-bg-style-scroll   container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-384'><div class='entry-content-wrapper clearfix'>\n<div class=\"flex_column av_one_fifth  flex_column_div first  \" style='padding:0px 0px 0px 12px ; border-radius:0px; '><div class='avia-button-wrap avia-button-left '><a href='https:\/\/cdsatoolkit.thsti.in\/?page_id=962' class='avia-button   avia-icon_select-yes-left-icon avia-color-custom avia-size-small avia-position-left '  style='background-color:#1d66a3; border-color:#1d66a3; color:#ffffff; ' ><span class='avia_button_icon avia_button_icon_left ' aria-hidden='true' data-av_icon='\ue888' data-av_iconfont='entypo-fontello'><\/span><span class='avia_iconbox_title' >Previous<\/span><\/a><\/div><\/div><div class=\"flex_column av_three_fifth  flex_column_div   \" style='padding:0px 0px 0px 0px ; border-radius:0px; '><div style='padding-bottom:10px;' class='av-special-heading av-special-heading-h2  blockquote modern-quote modern-centered   '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Randomization System Development and User Acceptance Testing<\/h2><div class='special-heading-border'><div class='special-heading-inner-border' ><\/div><\/div><\/div><\/div><div class=\"flex_column av_one_fifth  flex_column_div   \" style='padding:0px 0px 0px 0px ; border-radius:0px; '><div class='avia-button-wrap avia-button-right '><a href='https:\/\/cdsatoolkit.thsti.in\/?page_id=386' class='avia-button   avia-icon_select-yes-right-icon avia-color-custom avia-size-small avia-position-right '  style='background-color:#1d66a3; border-color:#1d66a3; color:#ffffff; ' ><span class='avia_iconbox_title' >Next<\/span><span class='avia_button_icon avia_button_icon_right' aria-hidden='true' data-av_icon='\ue889' data-av_iconfont='entypo-fontello'><\/span><\/a><\/div><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_1' class='main_color av_default_container_wrap container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-384'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='lop2' class='avia-section main_color avia-section-default avia-no-shadow avia-bg-style-scroll   container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-384'><div class='entry-content-wrapper clearfix'>\n<div class=\"flex_column av_one_full  flex_column_div first  \" style='padding:10px 0px 0px -20px ; border-radius:0px; '><section class=\"avia_codeblock_section  avia_code_block_0\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_codeblock '  itemprop=\"text\" > [avia_codeblock_placeholder uid=\"0\"] <\/div><\/section><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_2' class='main_color av_default_container_wrap container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-384'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='wwe' class='avia-section main_color avia-section-large avia-no-shadow avia-bg-style-scroll   container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-384'><div class='entry-content-wrapper clearfix'>\n<div class=\"flex_column av_two_third  flex_column_div first  \" style='padding:8px 0px 0px 14px ; border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><p style=\"text-align: justify;\">Randomization is the process of allocating people to treatment groups, using an element of chance to determine the assignment.<\/p>\n<p style=\"text-align: justify;\">Randomization is meant to reduce the chance of systematic bias that can be encountered if investigators, study staff, or volunteers are involved in making a decision about which treatment a volunteer receives. In the context of clinical trials, randomization is a method based on chance alone, by which eligible and consented volunteers are assigned to one of the study interventions.<\/p>\n<p>Randomization keeps treatment allocation free from selection bias.<\/p>\n<p style=\"text-align: justify;\">The primary reason for randomization in a clinical trial is to produce groups of patients who differ only in their treatment assignment. If these groups were to differ in some other way, then any future comparison might be biased.<\/p>\n<h4><strong>Randomization Procedure<\/strong><\/h4>\n<p style=\"text-align: justify;\">The randomization procedure should be detailed in the protocol. Ideally, it should be determined by the investigator and the biostatistician, by considering the following:<\/p>\n<ul>\n<li>Open trial vs. blinded trial<\/li>\n<li>Single blinded or double blinded<\/li>\n<li>Number of volunteers to be randomised<\/li>\n<li>Number of study sites<\/li>\n<li>Number of treatment groups or arms<\/li>\n<li>Treatment allocation ratio<\/li>\n<li>Stratification factors, if any.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">The randomization list and the method of implementation should be generated by biostatistician. The SOP should be detailed and should include the following:<\/p>\n<ul>\n<li>Brief description of the randomization process<\/li>\n<li>A record of variables used in the procedure<\/li>\n<li>Details of the person generating the randomization list<\/li>\n<li style=\"text-align: justify;\">Software used to generate the list and perform the randomization (if applicable), and validation details of the system.<\/li>\n<li style=\"text-align: justify;\">Approach used for allocation concealment (example: password protected electronic format)<\/li>\n<li>Details of the secure location where the randomization list is stored<\/li>\n<li style=\"text-align: justify;\">Details of the personnel who will have access to the randomization list. Please note, this list should not be accessible by the investigator and the trials team until database is locked and the code is officially broken at the end of the trial. For emergencies (example: adverse events or serious adverse events), the list can be provided to the investigator in a sealed envelope.<\/li>\n<li style=\"text-align: justify;\">Details of the person (should not be part of the study) who will securely hold the treatment codes.<\/li>\n<li style=\"text-align: justify;\">If the study is blinded, the details on how the IP will be packaged, coded and labelled to protect the blinding \u2013 these must be provided to the IP manufacturer.<\/li>\n<li style=\"text-align: justify;\">Details of any additional documents that have to be completed (due to randomization).<\/li>\n<li style=\"text-align: justify;\">Details on how the pharmacy will be informed of the randomised treatment code allocation. Example: via fax \/ email \/ other media.<\/li>\n<\/ul>\n<h4><strong>Blinding <\/strong><\/h4>\n<p style=\"text-align: justify;\">The protocol should also define the level of blinding in the trial, [examples are: unblinded (also called open), single-blind, or double-blinded]; also how the blinding will be implemented (example: use of identical placebo).<\/p>\n<h4><strong>Code Breaking <\/strong><\/h4>\n<p style=\"text-align: justify;\">The code breaking procedure must be thoroughly documented in the protocol, including the following:<\/p>\n<ul>\n<li><strong>Circumstances<\/strong> under which the blinding can be broken. Example:\n<ul style=\"line-space: 60%;\">\n<li style=\"text-align: justify; margin-top: -6px;\">Medical emergency where the knowledge of the blinded treatment is essential.<\/li>\n<li style=\"margin-top: -6px;\">Occurrence of an adverse event<\/li>\n<li style=\"margin-top: -6px;\">Someone in the volunteer\u2019s household accidentally takes the IP.<\/li>\n<li style=\"text-align: justify; margin-top: -6px;\">In the event of an SUSAR (Suspected Unexpected Serious Adverse Event) that might require expedited reporting.<\/li>\n<li style=\"margin-top: -6px;\">If requested by the DSMB.<\/li>\n<\/ul>\n<\/li>\n<li style=\"text-align: justify; margin-top: -10px;\">Details of the format of the code break (example: tear off labels \/ scratch cards \/ 24-hour telephone number \/ IVRS [Interactive Voice Response System] \/ IWRS [Interactive Web Response System], etc.).<\/li>\n<li style=\"text-align: justify; margin-top: -5px;\">Investigator can break the treatment blinding when a volunteer\u2019s safety is at risk. The code break process, process to be followed for notification, documentation to be recorded should be established at the time of trial planning (before a code is broken).<\/li>\n<li style=\"text-align: justify; margin-top: -5px;\">Secure location of code break envelopes.<\/li>\n<li style=\"text-align: justify; margin-top: -5px;\">Details of circumstances where a volunteer can continue to participate in the study following unblinding.<\/li>\n<\/ul>\n<h4><strong>Resources and further reading<\/strong><\/h4>\n<ul style=\"margin-top: 0px !important;\">\n<li style=\"text-align: justify; margin-top: 6px;\">Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available <a href=\"http:\/\/www.cdsco.nic.in\/html\/GCP1.html\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify; margin-top: -9px;\">ICH Harmonised Tripartite Guideline, Statistical Principles for Clinical Trials, E9, current step 4 version, dated 5<sup>th<\/sup> February 1998, available <a href=\"https:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E9\/Step4\/E9_Guideline.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify; margin-top: -4px;\">Clinical Development Services Agency SOP for Randomization, Blinding and Code Breaking Procedures, version 1.0, 2015.<\/li>\n<li style=\"margin-top: -4px;\">Online resource: Research Randomizer (free) &#8211; <a href=\"https:\/\/www.randomizer.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/www.randomizer.org\/<\/a><\/li>\n<\/ul>\n<\/div><\/section><\/div><div class=\"flex_column av_one_third  flex_column_div   \" style='padding:2px 2px 0px 0px ; border-radius:0px; '><div class='avia-builder-widget-area clearfix '><div id=\"custom_html-3\" class=\"widget_text widget clearfix widget_custom_html\"><h3 class=\"widgettitle\">Key Components<\/h3><div class=\"textwidget custom-html-widget\"><div class=\"hjubv\">\r\n\t\r\n\r\n<ol style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=1075\" style=\"color: #000;\">Trial Planning<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=319\" style=\"color: #000;\">Trial Design<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=309\" style=\"color: red;\">Sponsorship<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=333\" style=\"color: red;\">Funding<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=339\" style=\"color: #000;\">Internationally Funded Trials<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=862\" style=\"color: #000;\">Trial Set-Up<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=343\" style=\"color: red;\">Protocol Development<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=345\" style=\"color: red;\">Essential Documents<\/a><\/li>\r\n<\/ol>\t\r\n<p class=\"kaw\">\r\n<ul style=\"margin-top: -23px;\">\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=873\" style=\"color: red;\">Case Record Form<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=877\" style=\"color: red;\">Informed Consent Documents<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=880\" style=\"color: red;\">Investigator\u2019s Brochure<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=885\" style=\"color: #000;\">Trial Master File<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=363\" style=\"color: #000;\">Laboratory Related Documents<\/a><\/li>\r\n<\/ul>\r\n<\/p>\r\n<ol start=\"9\" style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=419\" style=\"color: #000;\">Risk Management<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=372\" style=\"color: #000;\">Quality and Process Management<\/a><\/li>\r\n<\/ol>\t\r\n<p class=\"kaw\">\r\n<ul style=\"margin-top: -23px;\">\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=374\" style=\"color: #000;\">Sponsor Specific Processes and Documents<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=376\" style=\"color: #000;\">Pharmacovigilance Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=378\" style=\"color: #000;\">Monitoring Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=962\" style=\"color: #000;\">Safety Management Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=384\" style=\"color: #000;\">Randomisation System Development and User Acceptance Testing<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=386\" style=\"color: #000;\">Database Design, Development and User Acceptance Testing<\/a> <\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=355\" style=\"color: #000;\">Statistical Analysis Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=380\" style=\"color: #000;\">Data Management Plan<\/a> <\/li>\r\n<\/ul>\r\n<\/p>\r\n<ol start=\"11\" style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=399\" style=\"color: #000;\">Site Feasibility and Selection<\/a><\/li>\r\n<\/ol>\t\r\n<p class=\"kaw\">\r\n<ul style=\"margin-top: -23px;\">\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=401\" style=\"color: #000;\">Site Identification and Evaluation<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=382\" style=\"color: #000;\">Site-specific Processes and Documents<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=906\" style=\"color: red;\">Clinical Trial Agreement and Investigator\u2019s Undertaking<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=409\" style=\"color: #000;\">Site Staff Training<\/a><\/li>\r\n<\/ul>\r\n<\/p>\r\n<ol start=\"12\" style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=812\" style=\"color: #000;\">Trial Drug Supplies<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=815\" style=\"color: #000;\">Approvals and Registration<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=421\" style=\"color: red;\">Regulatory Approval<\/a><\/li>\r\n    <li style=\"color:red !important\"><a href=\"\/?page_id=425\" style=\"color: red;\">Ethics Approval<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=852\" style=\"color: red;\">Clinical Trial Registration<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=423\" style=\"color: #000;\">Other Approvals<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=433\" style=\"color: red;\">Final Protocol<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=836\" style=\"color: #000;\">Management and Oversight Groups<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=439\" style=\"color: #000;\">Trial Begins<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=453\" style=\"color: #000;\">Trial Conduct<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=498\" style=\"color: #000;\">Trial Close-Out<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=518\" style=\"color: #000;\">Statistical Analysis and Reports<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=510\" style=\"color: #000;\">Communication and Dissemination of Results<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=522\" style=\"color: red;\">Archiving<\/a><\/li>\r\n<\/ol>\r\n\t<\/div><\/div><\/div><div id=\"search-4\" class=\"widget clearfix widget_search\"><h3 class=\"widgettitle\">Search<\/h3>\n\n<form action=\"https:\/\/cdsatoolkit.thsti.in\/\" id=\"searchform\" method=\"get\" class=\"\">\n\t<div>\n\t\t<input type=\"submit\" value=\"\ue803\" id=\"searchsubmit\" class=\"button avia-font-entypo-fontello\" \/>\n\t\t<input type=\"text\" id=\"s\" name=\"s\" value=\"\" placeholder='Search' 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