{"id":409,"date":"2019-01-17T09:12:28","date_gmt":"2019-01-17T09:12:28","guid":{"rendered":"http:\/\/206.71.52.87\/~newwebproject\/?page_id=409"},"modified":"2019-08-09T08:29:53","modified_gmt":"2019-08-09T08:29:53","slug":"site-staff-training","status":"publish","type":"page","link":"https:\/\/cdsatoolkit.thsti.in\/?page_id=409","title":{"rendered":"Site Staff Training"},"content":{"rendered":"<div class=\"flex_column av_one_half  flex_column_div first  \" style='padding:0px 15px 0px 2px ; border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><div class=\"dfr1\"><strong>Clinical Trials Toolkit &#8211; India<\/strong><\/div>\n<\/div><\/section><\/div>\n<div class=\"flex_column av_one_half  flex_column_div   \" style='padding:0px -20px 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>Site Staff Training<\/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-409'><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=906' 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\"  >Site Staff Training<\/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:15px 0px 0px -15px ; border-radius:0px; '><div class='avia-button-wrap avia-button-right '><a href='https:\/\/cdsatoolkit.thsti.in\/?page_id=812' 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-409'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='lop1' 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-409'><div class='entry-content-wrapper clearfix'>\n<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>\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-409'><div class='entry-content-wrapper clearfix'><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='nbvc' 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-409'><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;\">Staff involved in the conduct of a clinical trial, across all sites must be trained with the help of Good Clinical Practice (GCP) guidelines, applicable SOPs and trial specific documents. Training of site staff is essential to ensure uniformity and compliance. Following is a suggestive list of documents that the site staff should be trained in:<\/p>\n<h4><strong>Standard guidelines and regulations that are available:<\/strong><\/h4>\n<ol>\n<li style=\"text-align: justify;\">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\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a>.<\/li>\n<li style=\"text-align: justify;\">New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available <a href=\"https:\/\/cdsco.gov.in\/opencms\/export\/sites\/CDSCO_WEB\/Pdf-documents\/NewDrugs_CTRules_2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a>.<\/li>\n<li style=\"text-align: justify;\">National Ethical Guidelines for Biomedical and Health Research involving Human Participants, Indian Council of Medical Research, 2017, available <a href=\"https:\/\/www.icmr.nic.in\/sites\/default\/files\/guidelines\/ICMR_Ethical_Guidelines_2017.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a>.<\/li>\n<li style=\"text-align: justify;\">ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9<sup>th <\/sup>November 2016, available <a href=\"https:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E6\/E6_R2__Step_4_2016_1109.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a>(if applicable).<\/li>\n<\/ol>\n<h4><strong>Trial-specific processes and documents: <\/strong><\/h4>\n<ol>\n<li style=\"text-align: justify;\">Approved Protocol and amendments, if any: This should be a detailed training, including eligibility criteria, participant and data flow, study procedures, etc.<\/li>\n<li style=\"text-align: justify;\">Informed Consent Documents and process of obtaining consent.<\/li>\n<li>Investigator Brochure (IB).<\/li>\n<li style=\"text-align: justify;\">Recruitment process: Process of screening potential participants and appropriate method of obtaining informed consent.<\/li>\n<li style=\"text-align: justify;\">Case Record Form (CRF): Staff should be trained with the help of CRF Completion Manual, relevant SOPs (if available) and query management. If specific equipment is to be used for electronic data capture (eCRF), then, these must be utilised for training.<\/li>\n<li style=\"text-align: justify;\">Investigational Product (IP): Depending on the trial, the staff must be trained in IP handling, storage, retrieval, destruction, etc.<\/li>\n<li style=\"text-align: justify;\">Documentation: The staff must be trained in filing and maintenance of Investigator Site File (ISF) (as applicable).<\/li>\n<li style=\"text-align: justify;\">Safety Reporting: The staff should be aware of the applicable timelines for reporting Adverse and Serious Adverse Events, and the forms that are to be completed.<\/li>\n<li style=\"text-align: justify;\">Protocol Deviation: The staff should be aware of the procedure to be followed in the event of a deviation from protocol (notification to the Ethics Committee, CDSCO and sponsor).<\/li>\n<li style=\"text-align: justify;\">Duty Delegation Log: With the help of a duty delegation log, the staff should be made aware of their specific responsibilities. This log also enlists the logs and forms that have to be completed, as per the regulatory requirements.<\/li>\n<li>Any other specific activities (if planned). Some examples are:<\/li>\n<\/ol>\n<ul>\n<li style=\"text-align: justify;\">If the trial includes sample collection and transport to an external laboratory, then, designated site staff should be made aware of the process to be followed for the transport, and appropriate logs and forms that are to be completed.<\/li>\n<li>Specific follow-up procedures to be followed<\/li>\n<li style=\"text-align: justify;\">If any sub-studies are planned, then, the staff must be aware of the procedures to be followed for these.<\/li>\n<li>Preparation for monitoring visits (if planned)<\/li>\n<li style=\"text-align: justify;\">Completion of any other participant material like questionnaires, diaries, etc.<\/li>\n<li style=\"text-align: justify;\">IATA (International Air Transport Association) guidelines, if applicable.<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">It is advisable that the site investigator and the monitoring team ensure ongoing training and development of the site staff. On the basis of their evaluation, re-training of the site staff may be conducted.<\/p>\n<h4><strong>References<\/strong><\/h4>\n<ul style=\"margin-top: 0.5em !important;\">\n<li style=\"text-align: justify;\">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\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9<sup>th <\/sup>November 2016, available <a href=\"https:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E6\/E6_R2__Step_4_2016_1109.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">National Ethical Guidelines for Biomedical and Health Research involving Human Participants, Indian Council of Medical Research, 2017, available <a href=\"https:\/\/www.icmr.nic.in\/sites\/default\/files\/guidelines\/ICMR_Ethical_Guidelines_2017.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/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' \/>\n\t\t\t<\/div>\n<\/form><\/div><\/div><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_3' 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-409'><div class='entry-content-wrapper 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