{"id":812,"date":"2019-03-09T09:48:29","date_gmt":"2019-03-09T09:48:29","guid":{"rendered":"http:\/\/206.71.52.87\/~newwebproject\/?page_id=812"},"modified":"2019-08-09T08:31:34","modified_gmt":"2019-08-09T08:31:34","slug":"trial-drug-supplies","status":"publish","type":"page","link":"https:\/\/cdsatoolkit.thsti.in\/?page_id=812","title":{"rendered":"Trial Drug Supplies"},"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>Trial Drug Supplies<\/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-812'><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=409' 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\"  >Trial Drug Supplies<\/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=815' 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-812'><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-812'><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-812'><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-812'><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;\">The sponsor of a trial is responsible for providing the trial supplies, which includes the Investigational Product (IP), comparator(s), placebo(s), as applicable. It is essential that the drug supplies are manufactured in accordance to the principles of Good Manufacturing Practice (GMP), and packaged in a manner that protects the product from any deterioration or damage. The labelling should safeguard the blinding of the trial (if applicable). The manner of labelling should be in accordance to the <a href=\"https:\/\/cdsco.gov.in\/opencms\/export\/sites\/CDSCO_WEB\/Pdf-documents\/NewDrugs_CTRules_2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">New Drugs and Clinical Trial Rules, 2019<\/a>.<\/p>\n<p style=\"text-align: justify;\">The information on the label must include the following (but are not limited to):<\/p>\n<ul>\n<li>The words: \u201cFor Clinical Studies Only\u201d (in bold format)<\/li>\n<li>Name of the IP or code number<\/li>\n<li>Batch or Lot Number<\/li>\n<li>Name of the trial or Protocol Number or Protocol Identifier<\/li>\n<li>Participant code \/ Participant identification number<\/li>\n<li>Name and contact number of the investigator<\/li>\n<li style=\"text-align: justify;\">Name and address of the site\/institution where the trial is to be conducted<\/li>\n<li>Date of manufacture and use before date<\/li>\n<li>Storage conditions<\/li>\n<li>Name and address of the manufacturer<\/li>\n<\/ul>\n<p>The sponsor should determine the following:<\/p>\n<ul>\n<li>Reconstitution procedure (if applicable)<\/li>\n<li>Devices for product administration (if any).<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">The manner of labelling for a medical device for the purpose of test, evaluation, clinical investigation, etc. should be in accordance to the Medical Devices Rules, 2017 [<a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/system\/modules\/CDSCO.WEB\/elements\/download_file_division.jsp?num_id=MzMzNg\" target=\"_blank\" rel=\"noopener noreferrer\">G.S.R. 78(E)<\/a>] The labels of the containers for medical devices must indicate the following information:<\/p>\n<ul>\n<li>Name of the product or code number<\/li>\n<li>Batch or lot number<\/li>\n<li>Serial number (wherever applicable)<\/li>\n<li>Date of manufacture<\/li>\n<li>Use before date<\/li>\n<li>Storage conditions<\/li>\n<li>Name and address of the manufacturer<\/li>\n<li>Purpose for which it has been manufactured<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">The above should be communicated to all concerned parties, in writing, and also be stated on the product label (wherever possible). The trial supplies should not be made available at the site, until all required approvals have been received (ethics approval and\/or permission from the regulatory agency or any other local bodies). Once the draft labels have been approved by CDSCO, no changes in the label and\/or package insert shall be effected without an approval from the regulatory authority (CDSCO).<\/p>\n<p style=\"text-align: justify;\">Drug supplies shall be provided to sites along with documented procedures for the following:<\/p>\n<ul>\n<li style=\"text-align: justify;\">IP description and packaging (including all ingredients and formulation, and any placebos used in the trial)<\/li>\n<li>The precise dosing<\/li>\n<li>Method of packaging, labelling, and blinding of drug supplies<\/li>\n<li>Method of assigning treatments to the participants<\/li>\n<li>Participant identification code numbering system<\/li>\n<li style=\"text-align: justify;\">Adequate and safe receipt, handling, storage, and dispensing the product<\/li>\n<li>Retrieval of unused product from the trial participants<\/li>\n<li style=\"text-align: justify;\">Return of unused product to the sponsor (or its alternative disposal procedure).<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">Records of the following must be maintained by the sponsor, for the following:<\/p>\n<ul>\n<li style=\"text-align: justify;\">Investigators Brochure (IB) and its amendments (if any), or SmPC (Summary of Product Characteristics),or Package Insert for marketed drugs<\/li>\n<li>Certificates of Analysis (COA)<\/li>\n<li style=\"text-align: justify;\">Quantities of IP used \/procured for the study, with their batch numbers: It is important that the sponsor retains sufficient samples from each batch, that has been provided to the sites. Records of IP accountability logs should also be maintained at the trial level, site level and participant level.<\/li>\n<li>Quantity of IP supplied at each site.<\/li>\n<li style=\"text-align: justify;\">Dispensing of IP: The IP should be dispensed as per the randomization schedule (if applicable). During the trial, if the IP has not been handled and\/or dispensed according the relevant SOPs, it should be recorded and reported as per the sponsor\u2019s requirements. Each time the IP is dispensed to a participant, it should be appropriately recorded, and respective logs are filed in the Investigator Site File (ISF).<\/li>\n<li style=\"text-align: justify;\">Retrieval or destruction of the product after completion of the trial.<\/li>\n<li>Retrieval \/ Destruction SOPs and certificate (as applicable).<\/li>\n<li>Retrieval of quarantined \/expired product (whenever applicable)<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">During site close-out, it must be ensured that the IP accountability logs and forms are complete, and copies are retrieved for the Trial Master File (TMF). In addition to this, all unused trial supplies must be reconciled and returned to the sponsor or destroyed (in accordance to the sponsor\u2019s requirements and applicable regulatory guidelines). In case the IP is destroyed at the site, it is important to ensure that the relevant Destruction SOP is followed, and the Certificate is obtained from the Head of the Institution.<\/p>\n<h4><strong>References <\/strong><\/h4>\n<ul style=\"margin-top: 0.5em !important;\">\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> (last accessed on 03.04.2019).<\/li>\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;\">Medical Devices Rules, 2017, [ G.S.R. 78(E)], Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available <a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/system\/modules\/CDSCO.WEB\/elements\/download_file_division.jsp?num_id=MzMzNg\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 12.03.2019).<\/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;\">Clinical Development Services Agency SOP for Monitoring the Management of Investigational Product, version 1.0.<\/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 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