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<h2 id="history">History</h2> <p>ICH first published the GCP guidelines in 1996 under the "E6" category and was last amended in 2016.<a class="footnote-ref" id="fnref:2" href="#fn:2"><sup>2</sup></a> </p> <h2 id="legal-and-regulatory-status">Legal and regulatory status</h2> <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).<a class="footnote-ref" id="fnref:3" href="#fn:3"><sup>3</sup></a> A similar guideline for clinical trials of <a href="/facts/Medical_device/uzUHp474">medical devices</a> is the international standard <a href="/facts/ISO_14155/4p5XqMNf">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="/facts/Food_and_Drug_Administration/rCEnh9WB">Food and Drug Administration</a> (FDA),<a class="footnote-ref" id="fnref:4" href="#fn:4"><sup>4</sup></a> they are not statutory in the United States. The <a href="/facts/National_Institutes_of_Health/G3Eytfcc">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.<a class="footnote-ref" id="fnref:5" href="#fn:5"><sup>5</sup></a></li></ul> <h2 id="ich-gcp-overview">ICH GCP overview</h2> <ul><li>Glossary</li> <li>Principles of ICH GCP</li> <li>Guidelines for: <ul><li><a href="/facts/Institutional_review_board/kfgmngkI">institutional review board</a> (IRB) / independent ethics committee (IEC)</li> <li>investigator</li> <li>trial sponsor (industrial, academic)</li> <li><a href="/facts/Clinical_trial_protocol/CgKlqHj2">clinical trial protocol</a> and protocol amendments</li> <li><a href="/facts/Investigator%2527s_Brochure/w24LeYlX">investigator's brochure</a></li> <li>essential documents</li></ul></li></ul> <h2 id="criticism">Criticism</h2> <p>GCP has been called 'a less morally authoritative document' than the <a href="/facts/Declaration_of_Helsinki/f3NRTaxw">Declaration of Helsinki</a>, lacking moral principles and guidance in the following areas:<a class="footnote-ref" id="fnref:6" href="#fn:6"><sup>6</sup></a> </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="/facts/Bad_Pharma/xrU0Etpf">Bad Pharma</a></i>, <a href="/facts/Ben_Goldacre/rdFzsUnb">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".<a class="footnote-ref" id="fnref:7" href="#fn:7"><sup>7</sup></a> </p> <h2 id="see-also">See also</h2> <ul><li><a href="/facts/GxP/Lf1VI81e">GxP</a> – Good practice guidelines and regulations</li> <li><a href="/facts/Good_laboratory_practice/DXV9HLej">Good laboratory practice</a></li> <li><a href="/facts/Data_monitoring_committees/e1eduN41">Data monitoring committees</a> – ethical review organizationPages displaying wikidata descriptions as a fallback</li> <li><a href="/facts/Directive_2001%2f20%2fEC/dr6DMsSR">Directive 2001/20/EC</a> – European Union Directive (EU) 2001/20Pages displaying wikidata descriptions as a fallback</li> <li><a href="/facts/Drug_development/k34jgV4B">Drug development</a> – Process of bringing a new pharmaceutical drug to the market</li> <li><a href="/facts/EudraVigilance/PA77wEb7">EudraVigilance</a> – Processing NetworkPages displaying wikidata descriptions as a fallback</li> <li><a href="/facts/European_Forum_for_Good_Clinical_Practice/y8CGpwru">European Forum for Good Clinical Practice</a></li> <li><a href="/facts/European_Medicines_Agency/h9FTtCYc">European Medicines Agency</a> – Agency of the European Union</li> <li><a href="/facts/Institutional_review_board/kfgmngkI">Institutional review board</a> – Type of committee that applies research ethics</li> <li><a href="/facts/Inverse_benefit_law/d9T5mnDx">Inverse benefit law</a> – Drug benefit-harm ratio falls with marketing</li> <li><a href="/facts/Medical_ethics/Dm4TCznf">Medical ethics</a> – System of moral principles of the practice of medicine</li> <li><a href="/facts/Pharmaceutical_company/5mCITYys">Pharmaceutical company</a> – Industry involved with discovery, development, production and marketing of drugsPages displaying short descriptions of redirect targets</li> <li><a href="/facts/Pharmacovigilance/4v2PDxCM">Pharmacovigilance</a> – Drug safety; subdiscipline of pharmacy relating to prevention of adverse effects of drugs</li></ul> <h2 id="external-links">External links</h2> <ul><li><a href="https://www.fda.gov/downloads/Drugs/Guidances/UCM464506.pdf">ICH Topic E 6 (R2)</a></li> <li><a href="https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm">Good Clinical Practice</a> (from U.S. <a href="/facts/Food_and_Drug_Administration/rCEnh9WB">Food and Drug Administration</a>)</li></ul> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>"ICH Official web site : ICH". www.ich.org. Retrieved 2021-11-24. <a href="https://www.ich.org/page/efficacy-guidelines" target="_blank">https://www.ich.org/page/efficacy-guidelines</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>"Efficacy Guidelines". International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Archived from the original on 10 February 2022. Retrieved 12 September 2024. <a href="https://web.archive.org/web/20220210103236/https://www.ich.org/page/efficacy-guidelines" target="_blank">https://web.archive.org/web/20220210103236/https://www.ich.org/page/efficacy-guidelines</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>"Clinical trials - Directive 2001/20/EC - European Commission". <a href="https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-directive-200120ec_en" target="_blank">https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-directive-200120ec_en</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> <li id="fn:4"><p>Commissioner, Office of the. "Clinical Trials and Human Subject Protection". www.fda.gov. Retrieved 2018-11-01. <a href="https://www.fda.gov/scienceresearch/specialtopics/runningclinicaltrials/default.htm" target="_blank">https://www.fda.gov/scienceresearch/specialtopics/runningclinicaltrials/default.htm</a> <a href="#fnref:4" class="footnote-back-ref">↩</a></p></li> <li id="fn:5"><p>"Good Clinical Practice Training | grants.nih.gov". grants.nih.gov. Retrieved 2020-04-03. <a href="https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm" target="_blank">https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm</a> <a href="#fnref:5" class="footnote-back-ref">↩</a></p></li> <li id="fn:6"><p>Kimmelman, Jonathan; Weijer, Charles; Meslin, Eric M (2009). "Helsinki discords: FDA, ethics, and international drug trials". The Lancet. 373 (9657): 13–14. doi:10.1016/S0140-6736(08)61936-4. PMID 19121708. <a href="/wiki/Doi_(identifier)" target="_blank">/wiki/Doi_(identifier)</a> <a href="#fnref:6" class="footnote-back-ref">↩</a></p></li> <li id="fn:7"><p>Ben Goldacre (2012). Bad Pharma. London: Fourth Estate. OL 25682902M. <a href="/wiki/OL_(identifier)" target="_blank">/wiki/OL_(identifier)</a> <a href="#fnref:7" class="footnote-back-ref">↩</a></p></li> </ol>