{"id":343,"date":"2019-01-17T08:36:13","date_gmt":"2019-01-17T08:36:13","guid":{"rendered":"http:\/\/206.71.52.87\/~newwebproject\/?page_id=343"},"modified":"2019-08-09T06:59:26","modified_gmt":"2019-08-09T06:59:26","slug":"protocol-development","status":"publish","type":"page","link":"https:\/\/cdsatoolkit.thsti.in\/?page_id=343","title":{"rendered":"Protocol Development"},"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 -18px 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>Protocol Development<\/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-343'><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=862' 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\"  >Protocol Development<\/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=345' 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-343'><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-343'><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-343'><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-343'><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;\">Protocol is a document that describes the background, objectives, rationale, design, methodology (including the methods for dealing with AEs, withdrawals etc.) and statistical considerations of the study. It also describes the conditions under which the study shall be performed and managed. The content and format of the protocol should take into consideration the adopted Standard Operating Procedures (SOPs), the regulatory requirements and the guiding principles of Good Clinical Practice. The term protocol, unless otherwise specified, relates to the latest version of the document, read in conjunction with all its appendices and enclosures.<\/p>\n<p style=\"text-align: justify;\">A well-designed study relies predominantly on a robust and complete protocol. Therefore, it is advisable that the protocol is developed with contributions from a multi-disciplinary team (therapeutic experts, clinicians, operational experts, Investigational Product experts, biostatisticians, medical monitoring experts, etc.)<\/p>\n<h4><strong>Resources for protocol development<\/strong><\/h4>\n<p style=\"text-align: justify;\">Provided below are standard templates that can be used by researchers to develop and design their study protocol:<\/p>\n<ul>\n<li style=\"text-align: justify;\">Table 2 of the Third Schedule (page 213) in 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> outlines the essential components of a proposed protocol. <a href=\"https:\/\/marketbaba.com\/newwebproject\/wp-content\/uploads\/2019\/03\/Protocol-format-as-per-Schedule-Y.docx\" target=\"_blank\" rel=\"noopener noreferrer\">This template<\/a> can be used to develop a protocol as per the information provided.<\/li>\n<li style=\"text-align: justify;\">Checklist and format, to guide preparation of a protocol, adapted from the National Ethical Guidelines for Biomedical and Health Research involving Human Participants. <a href=\"https:\/\/marketbaba.com\/newwebproject\/wp-content\/uploads\/2019\/03\/Protocol-format-as-per-ICMR-guidelines-01.docx\" target=\"_blank\" rel=\"noopener noreferrer\">This document<\/a> may be used as a template to prepare a protocol.<\/li>\n<li style=\"text-align: justify;\">ICMR and CDSCO have provided a Study Protocol Guidance in the <a href=\"http:\/\/www.cdsco.nic.in\/writereaddata\/Scan1.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Handbook<\/a> for Applicants and Reviewers of Clinical Trials of New Drugs in India. <a href=\"https:\/\/marketbaba.com\/newwebproject\/wp-content\/uploads\/2019\/03\/Protocol-format-as-per-ICMR-guidelines-01.docx\" target=\"_blank\" rel=\"noopener noreferrer\">This template<\/a> may be used to prepare a protocol as per the guidance available in this handbook.<\/li>\n<li style=\"text-align: justify;\">The SPIRIT website provides comprehensive resources for protocol writing (<a href=\"http:\/\/www.spirit-statement.org\/schedule-of-enrolment-interventions-and-assessments\/\" target=\"_blank\" rel=\"noopener noreferrer\">figure<\/a>, \u00a0<a href=\"http:\/\/www.spirit-statement.org\/wp-content\/uploads\/2013\/01\/SPIRIT-Checklist-download-8Jan13.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">checklist<\/a> and <a href=\"http:\/\/www.spirit-statement.org\/publications-downloads\/\" target=\"_blank\" rel=\"noopener noreferrer\">paper<\/a>).<\/li>\n<li style=\"text-align: justify;\">CReDO <a href=\"https:\/\/www.nhlbi.nih.gov\/files\/docs\/clinical-research-guide-protocol-template.doc\" target=\"_blank\" rel=\"noopener noreferrer\">Template<\/a> &#8211; developed during a workshop conducted by Tata Memorial Centre and National Cancer Grid of India (<a href=\"https:\/\/tmc.gov.in\/credo\/\" target=\"_blank\" rel=\"noopener noreferrer\">https:\/\/tmc.gov.in\/credo\/<\/a>).<\/li>\n<li style=\"text-align: justify;\">The NIH (National Institutes of Health) has developed an <a href=\"https:\/\/nccih.nih.gov\/sites\/nccam.nih.gov\/files\/CR-Toolbox\/ProtocolTemplate_NCCIH_07-17-2015.docx\" target=\"_blank\" rel=\"noopener noreferrer\">online tool<\/a> for protocol writing and a <a href=\"https:\/\/e-protocol.od.nih.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">guidance document<\/a>. Both the document and the online tool should be used in consideration with the Indian regulatory requirements.<\/li>\n<li>The WHO also has a suggestive <a href=\"http:\/\/www.who.int\/rpc\/research_ethics\/format_rp\/en\/\" target=\"_blank\" rel=\"noopener noreferrer\">template<\/a> that can be used.<\/li>\n<li>The National Institute for Health Research has <a href=\"https:\/\/www.hra.nhs.uk\/planning-and-improving-research\/research-planning\/protocol\/\" target=\"_blank\" rel=\"noopener noreferrer\">two templates<\/a> available.<\/li>\n<\/ul>\n<h4><strong>Additional points to be considered during protocol development <\/strong><\/h4>\n<ul>\n<li style=\"text-align: justify;\">The protocol (and other essential documents) must be a version controlled document, i.e. dated and numbered.<\/li>\n<li style=\"text-align: justify;\">From the point of view of quality, it is essential that the Protocol discusses the Quality Management plan (Quality Assurance and Quality Control measures) of the trial.<\/li>\n<li style=\"text-align: justify;\">The protocol must elaborate on processes that will be carried out during the trial to ensure data credibility, and which personnel will have access to the source data \/ raw data.<\/li>\n<li style=\"text-align: justify;\"><a href=\"https:\/\/www.ctti-clinicaltrials.org\/files\/principles_document_finaldraft_19may15_1.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">This<\/a> document by the Clinical Trials Transformation Initiative (CTTI) discusses questions to consider for each Clinical Trial Quality Factor, at the time of trial design and protocol development. These factors are critical to data integrity and reliability, and protection of research participants.<\/li>\n<\/ul>\n<h4><strong>Resources for Sample Size Calculation<\/strong><\/h4>\n<ul>\n<li style=\"text-align: justify;\"><a href=\"http:\/\/openepi.com\/Menu\/OE_Menu.htm\" target=\"_blank\" rel=\"noopener noreferrer\">OpenEpi<\/a> is a free, open source software that can be used for calculating the sample size in epidemiological studies. The website also provides links to many internet-based calculators.<\/li>\n<li style=\"text-align: justify;\"><a href=\"https:\/\/www.cmc-biostatistics.ac.in\/nmaster\/\" target=\"_blank\" rel=\"noopener noreferrer\">nMaster 2.0<\/a> is a software developed by the Department of Biostatistics, CMC Vellore for sample size calculation. This is however not a free software and one can contact the nMaster team for conditions of its use.<\/li>\n<\/ul>\n<h4><strong>Role of Patient Public Involvement (PPI) during protocol development (community engagement)<\/strong><\/h4>\n<p style=\"text-align: justify;\">Involvement of the community or the public can enhance the way research is conducted, communicated and interpreted. Representatives from the community can be instrumental in ensuring better public engagement, thereby enabling a conducive environment for research. Unlike other countries, patient public involvement is not mandatory in the research process in India. However, it is recommended that the researcher considers the contribution from the community before, during and after the research, to mitigate culturally sensitive issues, and ensure that the health requirements of the community are being addressed. The researcher may decide the degree of their engagement considering the type of research being carried out.<\/p>\n<p style=\"text-align: justify;\">An example of engaging the community during the trial is by forming a Community Advisory Board or Group (CAB or CAG). This group can act as an interface between the community, the researcher and the ethics committee. It is important to highlight that; CAB or CAG does not replace individual informed consent.<\/p>\n<h4><strong>Further reading for PPI <\/strong><\/h4>\n<ol>\n<li style=\"text-align: justify;\">Sahay, S., &amp; Mehendale, S. (2011). Engaging community to support HIV prevention research. Eastern journal of medicine: EJM, 16(2), 168-177, <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3691695\/\" target=\"_blank\" rel=\"noopener noreferrer\">link<\/a> to the article.<\/li>\n<li style=\"text-align: justify;\">Sahay, S., Kumar, M., Srikrishnan, A. K., Ramanathan, V., &amp; Mehendale, S. (2013). Experiences in recruiting volunteers through community based initiatives in phase-1 vaccine trials in India. Human vaccines &amp; immunotherapeutics, 10(2), 485-91, <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4185896\/\" target=\"_blank\" rel=\"noopener noreferrer\">link<\/a> to the article.<\/li>\n<\/ol>\n<h4><strong>References<\/strong><\/h4>\n<ul>\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 online (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;\">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\" 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