{"id":309,"date":"2019-01-17T08:30:27","date_gmt":"2019-01-17T08:30:27","guid":{"rendered":"http:\/\/206.71.52.87\/~newwebproject\/?page_id=309"},"modified":"2019-08-27T09:11:14","modified_gmt":"2019-08-27T09:11:14","slug":"sponsorship","status":"publish","type":"page","link":"https:\/\/cdsatoolkit.thsti.in\/?page_id=309","title":{"rendered":"Sponsorship"},"content":{"rendered":"<div class=\"flex_column av_one_half  flex_column_div first  \" style='padding:0px 15px 0px 0px ; 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_one_half  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>Sponsorship<\/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-309'><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=319' 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\"  >Sponsorship<\/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 -15px ; border-radius:0px; '><div class='avia-button-wrap avia-button-right '><a href='https:\/\/cdsatoolkit.thsti.in\/?page_id=333' 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-309'><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-309'><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-309'><div class='entry-content-wrapper clearfix'>\n<\/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-309'><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>All health-related research requires a designated sponsor.<\/p>\n<p style=\"text-align: justify;\">The sponsor is an individual or a company or an institution that takes the responsibility for the initiation, management and \/ or financing of a clinical trial. An investigator who independently initiates and takes full responsibility for a trial automatically assumes the role of a sponsor.<\/p>\n<p style=\"text-align: justify;\">The sponsor may delegate certain activities or tasks to the study team. However, the overall responsibility for the quality and integrity of the data will reside with the sponsor. According to the <a href=\"https:\/\/cdsco.gov.in\/opencms\/opencms\/system\/modules\/CDSCO.WEB\/elements\/download_file_division.jsp?num_id=NDI2MQ==\" target=\"_blank\" rel=\"noopener noreferrer\">New Drugs and Clinical Trial Rules, 2019<\/a> and the <a href=\"http:\/\/www.cdsco.nic.in\/html\/GCP1.html\" target=\"_blank\" rel=\"noopener noreferrer\">GCP guidelines<\/a>, following are some of the major responsibilities of a sponsor<\/p>\n<h4><strong>Before the trial commences the sponsor is responsible for:<\/strong><\/h4>\n<ul style=\"margin-top: 0.6em !important;\">\n<li style=\"text-align: justify;\">Selection of appropriate investigator(s) and site(s) and if required CRO (Contract Research Organization)<\/li>\n<li style=\"text-align: justify;\">Formal contract with the investigator for all research related activities and responsibilities (Clinical Trials Agreement).<\/li>\n<li style=\"text-align: justify;\">In case of a CRO, document the transfer of trial related duties in the form of an agreement or contract, between the two parties.<\/li>\n<li style=\"text-align: justify;\">Ensuring that only qualified personnel are involved throughout the trial process.<\/li>\n<li style=\"text-align: justify;\">Development of detailed SOPs (to ensure compliance).<\/li>\n<li style=\"text-align: justify;\">Confirmation of review by an Ethics Committee (registered \u2013 in case of regulatory clinical trials). The sponsor should obtain the documented approval, re-approval, withdrawal or suspensions, etc.<\/li>\n<li style=\"text-align: justify;\">Development and provision of essential documents \u2013 including Investigator\u2019s Brochure and Investigational Product handling and safety information.<\/li>\n<li style=\"text-align: justify;\">Designation of qualified medical experts \/ personnel who are available to advise on trial related concerns and issues, supervise the overall conduct of the study, etc.<\/li>\n<li style=\"text-align: justify;\">Ensuring that the trial site(s) has adequate supply of the Investigational Product (IP), and that the team is trained to handle and store the IP as per recommendation.<\/li>\n<li style=\"text-align: justify;\">Setting up a Data Safety Monitoring Board (DSMB) also known as Independent Data Monitoring Committee (IDMC), to assess the progress of a clinical trial, etc.<\/li>\n<li style=\"text-align: justify;\">Sponsor may also consider reimbursement to be paid to the participants for their time and expenses incurred. All such reimbursements have to be approved by the Ethics Committee.<\/li>\n<\/ul>\n<h4><strong>During the trial the sponsor is responsible for:<\/strong><\/h4>\n<ul style=\"margin-top: 0.6em !important;\">\n<li style=\"text-align: justify;\">Submission of status report (of the trial) in cases of regulatory trials to CDSCO at the prescribed frequency<\/li>\n<li style=\"text-align: justify;\">Implementation and maintenance of appropriate Quality Control and Quality Assurance systems in order to ensure data validity and integrity.<\/li>\n<li style=\"text-align: justify;\">Communication of all Serious Adverse Events (SAE\u2019s) to CDSCO and other investigators within 14 calendar days, as per the format provided in in Table 5 of the Third Schedule (page 218) in <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>. <a href=\"https:\/\/marketbaba.com\/newwebproject\/wp-content\/uploads\/2019\/08\/Format-for-reporting-Serious-Adverse-Events-SAEs-occurring-in-a-clinical-trial.docx\" target=\"_blank\" rel=\"noopener noreferrer\">This format<\/a> may be used for reporting SAEs in a clinical trial or Bioavailability or Bioequivalence study.<\/li>\n<li>Study management, data handling and record keeping<\/li>\n<li style=\"text-align: justify;\">Monitoring (risk-based, centralised \/ remote \/ on-site) and auditing (relevant SOPs and personnel).<\/li>\n<li style=\"text-align: justify;\">Ongoing safety evaluation of the Investigational Product. Notification to investigators, regulatory authorities and institutions of findings that could potentially impact participant safety, conduct of the trial, or alter the EC\u2019s approval.<\/li>\n<\/ul>\n<h4><strong>Post-trial responsibilities of a sponsor:<\/strong><\/h4>\n<ul style=\"margin-top: 0.6em !important;\">\n<li style=\"text-align: justify;\">Submission of a Summary Report \u2013 in case of premature discontinuation or termination of the trial \u2013 within 3 months (report should include brief description of the study, number of participants exposed to the drug, dose and duration of exposure, details of adverse drug reactions, if any, and the reason for discontinuation of the study).<\/li>\n<li>Study reports (Clinical Study Report \/ Study Report)<\/li>\n<li>Appropriate archival of study related documents<\/li>\n<li>Appropriate disposal of left-over Investigational Product<\/li>\n<li style=\"text-align: justify;\">Post-trial access must be granted under specific circumstances, when the investigator has recommended it, and it has been approved by the Central Licensing Authority (i.e. CDSCO) and the Ethics Committee, and the with the participant\u2019s consent (please refer to Rule 27 of Chapter V (page 157), in the New Drugs and Clinical Trial Rules, 2019). If applicable, it is the responsibility of the sponsor to provide post-trial access of the investigational drug to the participant, free of cost.<\/li>\n<\/ul>\n<h4><strong>Additional roles and responsibilities:<\/strong><\/h4>\n<p style=\"text-align: justify;\">In addition to the above-mentioned roles, some additional roles have been envisaged for the sponsor as part of GCP. These are:<\/p>\n<p>The sponsor must <strong>ensure<\/strong> that:<\/p>\n<ol type=\"A\">\n<li>All sites follow the relevant regulatory principles, protocol, GCP guidelines, SOPs, etc.<\/li>\n<li>The study at all sites start and end simultaneously.<\/li>\n<li style=\"text-align: justify;\">The SOP includes the roles and responsibilities of the coordinating committee (Trial Steering Committee \/ Project Management Group) \u2013 if such a committee has been set up.<\/li>\n<\/ol>\n<p>The Sponsor must <strong>arrange<\/strong> for the following:<\/p>\n<ol type=\"A\">\n<li>Training of all staff members (including the site staff).<\/li>\n<li style=\"text-align: justify;\">Facilitate communication between the various site investigators (in case of a multicentre study).<\/li>\n<li style=\"text-align: justify;\">Appropriate design of the Case Record Forms (CRF) \u2013 considering the data that has to be collected.<\/li>\n<\/ol>\n<p>The Sponsor must <strong>document<\/strong> and <strong>design<\/strong> the following:<\/p>\n<ol type=\"A\">\n<li>The Ethics Committees that have to be consulted.<\/li>\n<li>Roles and responsibilities of the coordinating investigator.<\/li>\n<li style=\"text-align: justify;\">Roles and responsibilities of the Contract Research Organisation (CRO) \u2013 if it has been contracted.<\/li>\n<li>Randomisation procedure.<\/li>\n<li style=\"text-align: justify;\">Standardisation and validation of methods of evaluation, and analyses of data (at each site).<\/li>\n<li>Structure and function of a centralised data management set-up.<\/li>\n<li style=\"text-align: justify;\">Adverse Event Reporting &#8211;\u00a0 the Sponsor must ensure that the safety reporting is done as per the regulatory requirements.<\/li>\n<\/ol>\n<h4><strong>Role of a foreign Sponsor or when a Contract Research Organization is involved:<\/strong><\/h4>\n<p style=\"text-align: justify;\">A foreign sponsor (an organisation situated outside India) should appoint a local representative or Contract Research Organisation (CRO) to fulfil local responsibilities as per the guidelines, and the transfer of duties must be documented. The ultimate responsibility of the quality and integrity of data resides only with the sponsor, even if a CRO has been involved.<\/p>\n<h4><strong>Investigator initiated clinical trials<\/strong><\/h4>\n<p style=\"text-align: justify;\">Academicians often conduct research based on their observations in clinical practice or in response to a specific need of the patients. Such trials are also known as Investigator-initiated trials. These trials often do not have any funding support from external agencies. In such trials, the investigator or the host institution(where the research is conducted) will act as the sponsor for the trial, and will have all the responsibilities as described previously.<\/p>\n<h4><strong>References and Further Reading<\/strong><\/h4>\n<ul style=\"margin-top: 0.6em !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;\">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 01.04.2019).<\/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 05.07.2019).<\/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><\/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 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