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class="firstHeading mw-first-heading"><span class="mw-page-title-main">Good clinical practice</span></h1> <div id="p-lang-btn" class="vector-dropdown mw-portlet mw-portlet-lang" > <input type="checkbox" id="p-lang-btn-checkbox" role="button" aria-haspopup="true" data-event-name="ui.dropdown-p-lang-btn" class="vector-dropdown-checkbox mw-interlanguage-selector" aria-label="Go to an article in another language. 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class="interlanguage-link interwiki-da mw-list-item"><a href="https://da.wikipedia.org/wiki/God_klinisk_praksis" title="God klinisk praksis – Danish" lang="da" hreflang="da" data-title="God klinisk praksis" data-language-autonym="Dansk" data-language-local-name="Danish" class="interlanguage-link-target"><span>Dansk</span></a></li><li class="interlanguage-link interwiki-de mw-list-item"><a href="https://de.wikipedia.org/wiki/Gute_klinische_Praxis" title="Gute klinische Praxis – German" lang="de" hreflang="de" data-title="Gute klinische Praxis" data-language-autonym="Deutsch" data-language-local-name="German" class="interlanguage-link-target"><span>Deutsch</span></a></li><li class="interlanguage-link interwiki-fr mw-list-item"><a href="https://fr.wikipedia.org/wiki/Bonne_pratique_clinique" title="Bonne pratique clinique – French" lang="fr" hreflang="fr" data-title="Bonne pratique clinique" data-language-autonym="Français" data-language-local-name="French" class="interlanguage-link-target"><span>Français</span></a></li><li class="interlanguage-link interwiki-it mw-list-item"><a href="https://it.wikipedia.org/wiki/Buona_pratica_clinica" title="Buona pratica clinica – Italian" lang="it" hreflang="it" data-title="Buona pratica clinica" data-language-autonym="Italiano" data-language-local-name="Italian" class="interlanguage-link-target"><span>Italiano</span></a></li><li class="interlanguage-link interwiki-nl mw-list-item"><a href="https://nl.wikipedia.org/wiki/Goede_klinische_praktijken" title="Goede klinische praktijken – Dutch" lang="nl" hreflang="nl" data-title="Goede klinische praktijken" data-language-autonym="Nederlands" data-language-local-name="Dutch" class="interlanguage-link-target"><span>Nederlands</span></a></li><li class="interlanguage-link interwiki-ja mw-list-item"><a href="https://ja.wikipedia.org/wiki/%E8%89%AF%E3%81%8D%E8%87%A8%E5%BA%8A%E4%B8%8A%E3%81%AE%E5%9F%BA%E6%BA%96" title="良き臨床上の基準 – Japanese" lang="ja" hreflang="ja" 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data-unpinned-container-id="vector-appearance-unpinned-container" > <div class="vector-pinnable-header-label">Appearance</div> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-pin-button" data-event-name="pinnable-header.vector-appearance.pin">move to sidebar</button> <button class="vector-pinnable-header-toggle-button vector-pinnable-header-unpin-button" data-event-name="pinnable-header.vector-appearance.unpin">hide</button> </div> </div> </div> </nav> </div> </div> <div id="bodyContent" class="vector-body" aria-labelledby="firstHeading" data-mw-ve-target-container> <div class="vector-body-before-content"> <div class="mw-indicators"> </div> <div id="siteSub" class="noprint">From Wikipedia, the free encyclopedia</div> </div> <div id="contentSub"><div id="mw-content-subtitle"><span class="mw-redirectedfrom">(Redirected from <a href="/w/index.php?title=Good_Clinical_Practice&redirect=no" class="mw-redirect" title="Good Clinical Practice">Good Clinical Practice</a>)</span></div></div> <div id="mw-content-text" class="mw-body-content"><div class="mw-content-ltr mw-parser-output" lang="en" dir="ltr"><div class="shortdescription nomobile noexcerpt noprint searchaux" style="display:none">International quality standard for drug testing and production</div> <p>In <a href="/wiki/Drug_development" title="Drug development">drug development</a> and <a href="/wiki/Pharmaceutical_manufacturing" title="Pharmaceutical manufacturing">production</a>, <b>good clinical practice</b> (<b>GCP</b>) is an international quality standard, which governments can then transpose into regulations for <a href="/wiki/Clinical_trial" title="Clinical trial">clinical trials</a> involving human subjects. GCP follows the <a href="/wiki/International_Council_for_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use" class="mw-redirect" title="International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use">International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use</a> (ICH), and enforces tight guidelines on <a href="/wiki/Ethical" class="mw-redirect" title="Ethical">ethical</a> aspects of <a href="/wiki/Clinical_research" title="Clinical research">clinical research</a>. </p><p>High standards are required in terms of comprehensive documentation for the clinical <a href="/wiki/Protocol_(science)" title="Protocol (science)">protocol</a>, record keeping, training, and facilities, including computers and software. <a href="/wiki/Quality_assurance" title="Quality assurance">Quality assurance</a> and inspections ensure that these <a href="/wiki/International_standard" title="International standard">standards</a> are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. </p><p>GCP guidelines<sup id="cite_ref-1" class="reference"><a href="#cite_note-1"><span class="cite-bracket">[</span>1<span class="cite-bracket">]</span></a></sup> include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called <a href="/wiki/Clinical_research_associate" title="Clinical research associate">clinical research associates</a>. </p><p>A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research. </p> <meta property="mw:PageProp/toc" /> <div class="mw-heading mw-heading2"><h2 id="History">History</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Good_clinical_practice&action=edit&section=1" title="Edit section: History"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>ICH first published the GCP guidelines in 1996 under the "E6" category and was last amended in 2016.<sup id="cite_ref-2" class="reference"><a href="#cite_note-2"><span class="cite-bracket">[</span>2<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="Legal_and_regulatory_status">Legal and regulatory status</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Good_clinical_practice&action=edit&section=2" title="Edit section: Legal and regulatory status"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li>European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC).<sup id="cite_ref-3" class="reference"><a href="#cite_note-3"><span class="cite-bracket">[</span>3<span class="cite-bracket">]</span></a></sup> A similar guideline for clinical trials of <a href="/wiki/Medical_device" title="Medical device">medical devices</a> is the international standard <a href="/wiki/ISO_14155" title="ISO 14155">ISO 14155</a>, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.</li> <li>United States: Although ICH GCP guidelines are recommended by the <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a> (FDA),<sup id="cite_ref-4" class="reference"><a href="#cite_note-4"><span class="cite-bracket">[</span>4<span class="cite-bracket">]</span></a></sup> they are not statutory in the United States. The <a href="/wiki/National_Institutes_of_Health" title="National Institutes of Health">National Institutes of Health</a> requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice.<sup id="cite_ref-5" class="reference"><a href="#cite_note-5"><span class="cite-bracket">[</span>5<span class="cite-bracket">]</span></a></sup></li></ul> <div class="mw-heading mw-heading2"><h2 id="ICH_GCP_overview">ICH GCP overview</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Good_clinical_practice&action=edit&section=3" title="Edit section: ICH GCP overview"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li>Glossary</li> <li>Principles of ICH GCP</li> <li>Guidelines for: <ul><li><a href="/wiki/Institutional_review_board" title="Institutional review board">institutional review board</a> (IRB) / independent ethics committee (IEC)</li> <li>investigator</li> <li>trial sponsor (industrial, academic)</li> <li><a href="/wiki/Clinical_trial_protocol" class="mw-redirect" title="Clinical trial protocol">clinical trial protocol</a> and protocol amendments</li> <li><a href="/wiki/Investigator%27s_Brochure" class="mw-redirect" title="Investigator's Brochure">investigator's brochure</a></li> <li>essential documents</li></ul></li></ul> <div class="mw-heading mw-heading2"><h2 id="Criticism">Criticism</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Good_clinical_practice&action=edit&section=4" title="Edit section: Criticism"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <p>GCP has been called 'a less morally authoritative document' than the <a href="/wiki/Declaration_of_Helsinki" title="Declaration of Helsinki">Declaration of Helsinki</a>, lacking moral principles and guidance in the following areas:<sup id="cite_ref-6" class="reference"><a href="#cite_note-6"><span class="cite-bracket">[</span>6<span class="cite-bracket">]</span></a></sup> </p> <ul><li>Disclosure of conflict of interest</li> <li>Public disclosure of study design</li> <li>Benefit for populations in which research is conducted</li> <li>Reporting of accurate results and publication of negative findings</li> <li>Access to treatment after research has been conducted</li> <li>Restriction of use of placebo in control group where effective alternative treatment is available</li></ul> <p>In the book <i><a href="/wiki/Bad_Pharma" title="Bad Pharma">Bad Pharma</a></i>, <a href="/wiki/Ben_Goldacre" title="Ben Goldacre">Ben Goldacre</a> mentions these criticisms and notes that the GCP rules "aren't terrible... [they are] more focused on procedures, while Helsinki clearly articulates moral principles".<sup id="cite_ref-7" class="reference"><a href="#cite_note-7"><span class="cite-bracket">[</span>7<span class="cite-bracket">]</span></a></sup> </p> <div class="mw-heading mw-heading2"><h2 id="See_also">See also</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Good_clinical_practice&action=edit&section=5" title="Edit section: See also"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1184024115">.mw-parser-output .div-col{margin-top:0.3em;column-width:30em}.mw-parser-output .div-col-small{font-size:90%}.mw-parser-output .div-col-rules{column-rule:1px solid #aaa}.mw-parser-output .div-col dl,.mw-parser-output .div-col ol,.mw-parser-output .div-col ul{margin-top:0}.mw-parser-output .div-col li,.mw-parser-output .div-col dd{page-break-inside:avoid;break-inside:avoid-column}</style><div class="div-col" style="column-width: 40em;"> <ul><li><a href="/wiki/GxP" title="GxP">GxP</a> – Good practice guidelines and regulations</li> <li><a href="/wiki/Good_laboratory_practice" title="Good laboratory practice">Good laboratory practice</a></li> <li><a href="/wiki/Data_monitoring_committees" class="mw-redirect" title="Data monitoring committees">Data monitoring committees</a> – ethical review organization<span style="display:none" class="category-wikidata-fallback-annotation">Pages displaying wikidata descriptions as a fallback</span></li> <li><a href="/wiki/Directive_2001/20/EC" class="mw-redirect" title="Directive 2001/20/EC">Directive 2001/20/EC</a> – European Union Directive (EU) 2001/20<span style="display:none" class="category-wikidata-fallback-annotation">Pages displaying wikidata descriptions as a fallback</span></li> <li><a href="/wiki/Drug_development" title="Drug development">Drug development</a> – Process of bringing a new pharmaceutical drug to the market</li> <li><a href="/wiki/EudraVigilance" title="EudraVigilance">EudraVigilance</a> – Processing Network<span style="display:none" class="category-wikidata-fallback-annotation">Pages displaying wikidata descriptions as a fallback</span></li> <li><a href="/wiki/European_Forum_for_Good_Clinical_Practice" title="European Forum for Good Clinical Practice">European Forum for Good Clinical Practice</a></li> <li><a href="/wiki/European_Medicines_Agency" title="European Medicines Agency">European Medicines Agency</a> – Agency of the European Union</li> <li><a href="/wiki/Institutional_review_board" title="Institutional review board">Institutional review board</a> – Type of committee that applies research ethics</li> <li><a href="/wiki/Inverse_benefit_law" title="Inverse benefit law">Inverse benefit law</a> – Drug benefit-harm ratio falls with marketing</li> <li><a href="/wiki/Medical_ethics" title="Medical ethics">Medical ethics</a> – System of moral principles of the practice of medicine</li> <li><a href="/wiki/Pharmaceutical_company" class="mw-redirect" title="Pharmaceutical company">Pharmaceutical company</a> – Industry involved with discovery, development, production and marketing of drugs<span style="display:none" class="category-annotation-with-redirected-description">Pages displaying short descriptions of redirect targets</span></li> <li><a href="/wiki/Pharmacovigilance" title="Pharmacovigilance">Pharmacovigilance</a> – Drug safety; subdiscipline of pharmacy relating to prevention of adverse effects of drugs</li></ul> </div> <div class="mw-heading mw-heading2"><h2 id="References">References</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Good_clinical_practice&action=edit&section=6" title="Edit section: References"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <style data-mw-deduplicate="TemplateStyles:r1239543626">.mw-parser-output .reflist{margin-bottom:0.5em;list-style-type:decimal}@media screen{.mw-parser-output .reflist{font-size:90%}}.mw-parser-output .reflist .references{font-size:100%;margin-bottom:0;list-style-type:inherit}.mw-parser-output .reflist-columns-2{column-width:30em}.mw-parser-output .reflist-columns-3{column-width:25em}.mw-parser-output .reflist-columns{margin-top:0.3em}.mw-parser-output .reflist-columns ol{margin-top:0}.mw-parser-output .reflist-columns li{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .reflist-upper-alpha{list-style-type:upper-alpha}.mw-parser-output .reflist-upper-roman{list-style-type:upper-roman}.mw-parser-output .reflist-lower-alpha{list-style-type:lower-alpha}.mw-parser-output .reflist-lower-greek{list-style-type:lower-greek}.mw-parser-output .reflist-lower-roman{list-style-type:lower-roman}</style><div class="reflist"> <div class="mw-references-wrap"><ol class="references"> <li id="cite_note-1"><span class="mw-cite-backlink"><b><a href="#cite_ref-1">^</a></b></span> <span class="reference-text"><style data-mw-deduplicate="TemplateStyles:r1238218222">.mw-parser-output cite.citation{font-style:inherit;word-wrap:break-word}.mw-parser-output .citation q{quotes:"\"""\"""'""'"}.mw-parser-output .citation:target{background-color:rgba(0,127,255,0.133)}.mw-parser-output .id-lock-free.id-lock-free a{background:url("//upload.wikimedia.org/wikipedia/commons/6/65/Lock-green.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-limited.id-lock-limited a,.mw-parser-output .id-lock-registration.id-lock-registration a{background:url("//upload.wikimedia.org/wikipedia/commons/d/d6/Lock-gray-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .id-lock-subscription.id-lock-subscription a{background:url("//upload.wikimedia.org/wikipedia/commons/a/aa/Lock-red-alt-2.svg")right 0.1em center/9px no-repeat}.mw-parser-output .cs1-ws-icon a{background:url("//upload.wikimedia.org/wikipedia/commons/4/4c/Wikisource-logo.svg")right 0.1em center/12px no-repeat}body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-free a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-limited a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-registration a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .id-lock-subscription a,body:not(.skin-timeless):not(.skin-minerva) .mw-parser-output .cs1-ws-icon a{background-size:contain;padding:0 1em 0 0}.mw-parser-output .cs1-code{color:inherit;background:inherit;border:none;padding:inherit}.mw-parser-output .cs1-hidden-error{display:none;color:var(--color-error,#d33)}.mw-parser-output .cs1-visible-error{color:var(--color-error,#d33)}.mw-parser-output .cs1-maint{display:none;color:#085;margin-left:0.3em}.mw-parser-output .cs1-kern-left{padding-left:0.2em}.mw-parser-output .cs1-kern-right{padding-right:0.2em}.mw-parser-output .citation .mw-selflink{font-weight:inherit}@media screen{.mw-parser-output .cs1-format{font-size:95%}html.skin-theme-clientpref-night .mw-parser-output .cs1-maint{color:#18911f}}@media screen and (prefers-color-scheme:dark){html.skin-theme-clientpref-os .mw-parser-output .cs1-maint{color:#18911f}}</style><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://www.ich.org/page/efficacy-guidelines">"ICH Official web site : ICH"</a>. <i>www.ich.org</i><span class="reference-accessdate">. Retrieved <span class="nowrap">2021-11-24</span></span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.ich.org&rft.atitle=ICH+Official+web+site+%3A+ICH&rft_id=https%3A%2F%2Fwww.ich.org%2Fpage%2Fefficacy-guidelines&rfr_id=info%3Asid%2Fen.wikipedia.org%3AGood+clinical+practice" class="Z3988"></span></span> </li> <li id="cite_note-2"><span class="mw-cite-backlink"><b><a href="#cite_ref-2">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://web.archive.org/web/20220210103236/https://www.ich.org/page/efficacy-guidelines">"Efficacy Guidelines"</a>. <a href="/wiki/International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use" title="International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use">International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use</a> (ICH). 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Retrieved <span class="nowrap">12 September</span> 2024</span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Efficacy+Guidelines&rft.pub=International+Council+for+Harmonisation+of+Technical+Requirements+for+Pharmaceuticals+for+Human+Use+%28ICH%29&rft_id=https%3A%2F%2Fwww.ich.org%2Fpage%2Fefficacy-guidelines&rfr_id=info%3Asid%2Fen.wikipedia.org%3AGood+clinical+practice" class="Z3988"></span></span> </li> <li id="cite_note-3"><span class="mw-cite-backlink"><b><a href="#cite_ref-3">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-directive-200120ec_en">"Clinical trials - Directive 2001/20/EC - European Commission"</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=unknown&rft.btitle=Clinical+trials+-+Directive+2001%2F20%2FEC+-+European+Commission&rft_id=https%3A%2F%2Fhealth.ec.europa.eu%2Fmedicinal-products%2Fclinical-trials%2Fclinical-trials-directive-200120ec_en&rfr_id=info%3Asid%2Fen.wikipedia.org%3AGood+clinical+practice" class="Z3988"></span></span> </li> <li id="cite_note-4"><span class="mw-cite-backlink"><b><a href="#cite_ref-4">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFCommissioner" class="citation web cs1">Commissioner, Office of the. <a rel="nofollow" class="external text" href="https://www.fda.gov/scienceresearch/specialtopics/runningclinicaltrials/default.htm">"Clinical Trials and Human Subject Protection"</a>. <i>www.fda.gov</i><span class="reference-accessdate">. Retrieved <span class="nowrap">2018-11-01</span></span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=www.fda.gov&rft.atitle=Clinical+Trials+and+Human+Subject+Protection&rft.aulast=Commissioner&rft.aufirst=Office+of+the&rft_id=https%3A%2F%2Fwww.fda.gov%2Fscienceresearch%2Fspecialtopics%2Frunningclinicaltrials%2Fdefault.htm&rfr_id=info%3Asid%2Fen.wikipedia.org%3AGood+clinical+practice" class="Z3988"></span></span> </li> <li id="cite_note-5"><span class="mw-cite-backlink"><b><a href="#cite_ref-5">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite class="citation web cs1"><a rel="nofollow" class="external text" href="https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm">"Good Clinical Practice Training | grants.nih.gov"</a>. <i>grants.nih.gov</i><span class="reference-accessdate">. Retrieved <span class="nowrap">2020-04-03</span></span>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=unknown&rft.jtitle=grants.nih.gov&rft.atitle=Good+Clinical+Practice+Training+%7C+grants.nih.gov&rft_id=https%3A%2F%2Fgrants.nih.gov%2Fpolicy%2Fclinical-trials%2Fgood-clinical-training.htm&rfr_id=info%3Asid%2Fen.wikipedia.org%3AGood+clinical+practice" class="Z3988"></span></span> </li> <li id="cite_note-6"><span class="mw-cite-backlink"><b><a href="#cite_ref-6">^</a></b></span> <span class="reference-text"><link rel="mw-deduplicated-inline-style" href="mw-data:TemplateStyles:r1238218222"><cite id="CITEREFKimmelmanWeijerMeslin2009" class="citation journal cs1">Kimmelman, Jonathan; Weijer, Charles; Meslin, Eric M (2009). 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London: Fourth Estate. <a href="/wiki/OL_(identifier)" class="mw-redirect" title="OL (identifier)">OL</a> <a rel="nofollow" class="external text" href="https://openlibrary.org/books/OL25682902M">25682902M</a>.</cite><span title="ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Bad+Pharma&rft.place=London&rft.pub=Fourth+Estate&rft.date=2012&rft_id=https%3A%2F%2Fopenlibrary.org%2Fbooks%2FOL25682902M%23id-name%3DOL&rft.au=Ben+Goldacre&rfr_id=info%3Asid%2Fen.wikipedia.org%3AGood+clinical+practice" class="Z3988"></span></span> </li> </ol></div></div> <div class="mw-heading mw-heading2"><h2 id="External_links">External links</h2><span class="mw-editsection"><span class="mw-editsection-bracket">[</span><a href="/w/index.php?title=Good_clinical_practice&action=edit&section=7" title="Edit section: External links"><span>edit</span></a><span class="mw-editsection-bracket">]</span></span></div> <ul><li><a rel="nofollow" class="external text" href="https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf">ICH Topic E 6 (R2)</a></li> <li><a rel="nofollow" class="external text" href="https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm">Good Clinical Practice</a> (from U.S. <a href="/wiki/Food_and_Drug_Administration" title="Food and Drug Administration">Food and Drug Administration</a>)</li></ul>    </div><noscript><img src="https://login.wikimedia.org/wiki/Special:CentralAutoLogin/start?type=1x1" alt="" width="1" height="1" style="border: none; position: absolute;"></noscript> <div class="printfooter" data-nosnippet="">Retrieved from "<a dir="ltr" href="https://en.wikipedia.org/w/index.php?title=Good_clinical_practice&oldid=1245291420">https://en.wikipedia.org/w/index.php?title=Good_clinical_practice&oldid=1245291420</a>"</div></div> <div id="catlinks" class="catlinks" data-mw="interface"><div id="mw-normal-catlinks" class="mw-normal-catlinks"><a href="/wiki/Help:Category" title="Help:Category">Categories</a>: <ul><li><a href="/wiki/Category:Good_clinical_practice" title="Category:Good clinical practice">Good clinical practice</a></li><li><a href="/wiki/Category:Clinical_research" title="Category:Clinical research">Clinical research</a></li><li><a href="/wiki/Category:Clinical_trials" title="Category:Clinical trials">Clinical trials</a></li><li><a href="/wiki/Category:Good_practice" title="Category:Good practice">Good practice</a></li></ul></div><div id="mw-hidden-catlinks" class="mw-hidden-catlinks mw-hidden-cats-hidden">Hidden categories: <ul><li><a href="/wiki/Category:Articles_with_short_description" title="Category:Articles with short description">Articles with short description</a></li><li><a href="/wiki/Category:Short_description_is_different_from_Wikidata" title="Category:Short description is different from Wikidata">Short description is different from Wikidata</a></li><li><a href="/wiki/Category:Pages_displaying_wikidata_descriptions_as_a_fallback_via_Module:Annotated_link" title="Category:Pages displaying wikidata descriptions as a fallback via Module:Annotated link">Pages displaying wikidata descriptions as a fallback via Module:Annotated link</a></li><li><a href="/wiki/Category:Pages_displaying_short_descriptions_of_redirect_targets_via_Module:Annotated_link" title="Category:Pages displaying short descriptions of redirect targets via Module:Annotated link">Pages displaying short descriptions of redirect targets via Module:Annotated link</a></li></ul></div></div> </div> </main> </div> <div class="mw-footer-container"> <footer id="footer" class="mw-footer" > <ul id="footer-info"> <li id="footer-info-lastmod"> This page was last edited on 12 September 2024, at 04:26<span class="anonymous-show"> (UTC)</span>.</li> <li id="footer-info-copyright">Text is available under the <a href="/wiki/Wikipedia:Text_of_the_Creative_Commons_Attribution-ShareAlike_4.0_International_License" title="Wikipedia:Text of the Creative Commons Attribution-ShareAlike 4.0 International License">Creative Commons Attribution-ShareAlike 4.0 License</a>; additional terms may apply. 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