{"id":363,"date":"2019-01-17T08:39:41","date_gmt":"2019-01-17T08:39:41","guid":{"rendered":"http:\/\/206.71.52.87\/~newwebproject\/?page_id=363"},"modified":"2019-08-09T07:04:45","modified_gmt":"2019-08-09T07:04:45","slug":"laboratory-related-documents","status":"publish","type":"page","link":"https:\/\/cdsatoolkit.thsti.in\/?page_id=363","title":{"rendered":"Laboratory Related Documents"},"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>Laboratory Related Documents<\/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-363'><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=885' 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\"  >Laboratory Related Documents<\/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=419' 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-363'><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-363'><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-363'><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-363'><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;\">In a clinical trial, it is the responsibility of the investigator to ensure that all laboratory procedures or tests are undertaken at laboratories that are compliant with applicable regulations, and operate at a satisfactory level of competence. To safeguard data credibility and reliability, the following must be ensured:<\/p>\n<ul>\n<li style=\"text-align: justify;\">Use only of standardized and validated test methods and systems<\/li>\n<li style=\"text-align: justify;\">All equipment (and reference materials, wherever applicable) are appropriately calibrated and traceable to international standards, to ensure their accuracy and precision<\/li>\n<li style=\"text-align: justify;\">All data, including raw (original) laboratory records are available for independent review and compliant with \u2018Good Documentation Practice\u2019<\/li>\n<\/ul>\n<p style=\"text-align: justify;\">It is recommended that tests\/procedures (clinical biochemistry, microbiology, haematology, clinical pathology, immunology, serology etc.), are conducted at a laboratory which is accredited to <a href=\"https:\/\/www.iso.org\/standard\/56115.html\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 15189 standards<\/a> [ISO 15189 is an international standard related to medical laboratories that specifies the quality management system requirements (including technical requirements)]. Similarly, it is advisable to ensure that the equipment are calibrated by an <a href=\"https:\/\/www.iso.org\/standard\/39883.html\" target=\"_blank\" rel=\"noopener noreferrer\">ISO 17025<\/a> accredited laboratory [ISO 17025 or <a href=\"https:\/\/www.iso.org\/standard\/66912.html\" target=\"_blank\" rel=\"noopener noreferrer\">ISO\/IEC 17025:2017<\/a> is for general requirements for the competence of testing and calibration laboratories]. Both ISO 15189 and ISO 17025 are accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories). NABL is a constituent board of Quality Council of India (QCI) and conducts third-party assessment of the technical competence of laboratories.<\/p>\n<p style=\"text-align: justify;\">Good Laboratory Practice (GLP) is described in detail under Schedule L-1 of the Drugs and Cosmetics Act and Rules there under. In 2005, GLP was made mandatory by the Indian drug regulators, CDSCO for all toxicity studies. GLP mainly relates to pre-clinical studies (animal toxicology) and is a quality system concerned with the organisational process and conditions, under which such studies are planned, performed, monitored, recorded, archived and Fulfilling GLP requirements provide vital inputs necessary for initiating a clinical (human) study and are a pre-requisite for regulatory approvals in many countries, including India.<\/p>\n<p style=\"text-align: justify;\">Good Clinical Laboratory Practice (GCLP) is a set of standards that provide guidance on implementing Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) principles to the analysis of samples from a clinical trial. In brief, GCLP applies the principles established under GLP for generation of data used in regulatory submissions involving the analysis of samples from a clinical trial. At the same time, GCLP ensures that the GCP principles are adhered to. This ensures the reliability and integrity of data generated by analytical laboratories. It is advisable to adopt GCLP in a clinical trial in order to ensure that the quality of the trial matches to the best global practices. GCLP guidelines by <a href=\"https:\/\/icmr.nic.in\/sites\/default\/files\/guidelines\/GCLP.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">ICMR (2008)<\/a>, <a href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/44092\" target=\"_blank\" rel=\"noopener noreferrer\">WHO (2009)<\/a> and <a href=\"https:\/\/www.niaid.nih.gov\/sites\/default\/files\/gclp.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">DAIDS (2013)<\/a> can be referred to and studied in detail.<\/p>\n<p style=\"text-align: justify;\">Depending on the type of clinical trial being conducted, laboratory specific essential documents may be required, and need to be included in the master files. Some of these are:<\/p>\n<ol>\n<li style=\"text-align: justify;\">Laboratory certification or accreditation or established quality control or external quality assessment or other validation (for example, accreditation from NABL).<\/li>\n<li style=\"text-align: justify;\">IQC (Internal Quality Control), EQUAS (External Quality Assurance), PT (Proficiency Testing) data, wherever applicable<\/li>\n<li>Normal reference ranges<\/li>\n<li style=\"text-align: justify;\">Calibration certificates (for equipment to be used in the laboratory) from ISO 17025 accredited laboratory<\/li>\n<li style=\"text-align: justify;\">Instructions or manual (Quality manual, Primary sample collection manual, wherever applicable) for the laboratory<\/li>\n<li>An agreement or contract with the laboratory<\/li>\n<li style=\"text-align: justify;\">Curriculum Vitae of the Head \/ In-charge of the laboratory and all personnel, job description of all personnel<\/li>\n<li style=\"text-align: justify;\">A record of retained samples (to be maintained throughout the course of the trial)<\/li>\n<li style=\"text-align: justify;\">All SOPs (Standard Operating Procedures) related to the laboratory and the clinical trial<\/li>\n<li style=\"text-align: justify;\">Record of all relevant correspondence between the laboratory and CRO \/ Sponsor and Investigator(s).<\/li>\n<\/ol>\n<p style=\"text-align: justify;\">The above list is not exhaustive, and should be customised as per the requirements of the trial being conducted. In addition to these, additional SOPs for laboratory procedures, should be maintained. Examples of SOPs include:<\/p>\n<ul>\n<li>SOP for quality control<\/li>\n<li>SOP for equipment calibration<\/li>\n<li>SOP for specimen collection<\/li>\n<li>SOP for accepting or rejecting a specimen<\/li>\n<li style=\"text-align: justify;\">SOP for specimen storage, recording, analysis, re-testing, disposal<\/li>\n<\/ul>\n<p>It is important to note that all personnel involved in such activities must be trained in in &#8220;good practice&#8221; quality guidelines and regulations (GxPs) before they embark upon their duties.<\/p>\n<h4><strong>References and Further Reading<\/strong><\/h4>\n<ul style=\"margin-top: 0.5em !important;\">\n<li style=\"text-align: justify;\">The Drugs and Cosmetic Acts and Rules, 1945, as amended up to the 30<sup>th<\/sup> of June 2005, Ministry of Health and Family Welfare, Government of India, available <a href=\"http:\/\/www.cdsco.nic.in\/writereaddata\/Drugs&amp;CosmeticAct.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/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;\">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;\">Becker, R. A., et al, Good Laboratory Practices and safety assessments, Environmental Health Perspectives, 2009, version 117, number 11, pages A482-83, available <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2801195\/#b1-ehp-117-a482\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">S. Food &amp; Drug Administration, Good Laboratory Practices for Conducting Nonclinical Laboratory Studies, 2005, 21CFR58, available <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=58&amp;showFR=1\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">Organization for Economic Co-operation and Development (OECD), OECD Principles of Good Laboratory Practice (as revised in 1997), 1998, available <a href=\"https:\/\/www.oecd-ilibrary.org\/environment\/oecd-principles-on-good-laboratory-practice_9789264078536-en\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">Good Clinical Laboratory Practices (GCLP), Indian Council of Medical Research, 2008, available <a href=\"https:\/\/icmr.nic.in\/sites\/default\/files\/guidelines\/GCLP.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 06.03.2019).<\/li>\n<li style=\"text-align: justify;\">UNICEF\/UNDP\/World Bank\/WHO Special Programme for Research and Training in Tropical Diseases, 2009, Good Clinical Laboratory Practice (GCLP), World Health Organization, available <a href=\"https:\/\/apps.who.int\/iris\/handle\/10665\/44092\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 06.03.2019).<\/li>\n<li style=\"text-align: justify;\">Division of AIDS (DAIDS) Guidelines for Good Clinical Laboratory Practice Standards, National Institute of Allergy and Infectious Diseases, final version 3.0, dated 9<sup>th<\/sup> July 2013, available <a href=\"https:\/\/www.niaid.nih.gov\/sites\/default\/files\/gclp.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 06.03.2019).<\/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 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