{"id":9054,"date":"2017-02-18T14:13:18","date_gmt":"2017-02-18T22:13:18","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=9054"},"modified":"2025-11-19T13:22:55","modified_gmt":"2025-11-19T21:22:55","slug":"good-clinical-practice-training","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/training\/required-training\/good-clinical-practice-training\/","title":{"rendered":"Good Clinical Practice Training"},"content":{"rendered":"<p>Researchers working in behavioral or biomedical clinical research must sometimes complete training in Good Clinical Practice (GCP) in order to meet the requirements of the organizations they are affiliated with, funding agencies, or study sponsors. GCP training educates researchers on the fundamental principles of conducting high quality clinical trials.<\/p>\n<h2>91探花 Requirements<\/h2>\n<p>The  91探花and HSD do not currently require that researchers complete GCP training.<\/p>\n<h2>FDA Regulated Research<\/h2>\n<p>The FDA does not have specific GCP training requirements, but sponsors of FDA regulated research, such as industry partners developing a new drug or device, may require that researchers complete GCP training in order to demonstrate that the researcher is qualified to work on the study.<\/p>\n<h3>Users Requiring the TransCelerate Mutual Recognition Statement<\/h3>\n<p>For the CITI GCP Refresher training, all required and optional modules must be taken to generate the <a href=\"https:\/\/support.citiprogram.org\/s\/article\/Guide-to-GCP-Mutual-Recognition-Completion-Documentation\">TransCelerate Mutual Recognition statement<\/a>.<\/p>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Industry Sponsored FDA Studies<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>Work with the sponsor to complete the training they provide.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Investigator Sponsored FDA Studies<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>Sponsor-Investigators may make use of several free GCP training options for themselves and their staff.<br \/>\n<strong>Training Options<\/strong>:<\/p>\n<ul>\n<li>The <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/required-training\/web-based-citi-training\/\">CITI Program<\/a> offers a 4 &#8211; 6 hour online course that is free if you are affiliated with  91探花or collaborating with someone who is affiliated with UW. If you complete the CITI Good Clinical Practice course, you will automatically be enrolled in the refresher course 180 days before the training expires.<\/li>\n<li>The National Institutes of Health offers free online courses at:\n<ul>\n<li><a href=\"http:\/\/gcplearningcenter.niaid.nih.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">NIAID GCP Learning Center<\/a><\/li>\n<li><a href=\"https:\/\/gcp.nidatraining.org\/\">NIDA Clinical Trials Network<\/a><\/li>\n<\/ul>\n<\/li>\n<li>Training provided by industry partners and recognized by <a href=\"http:\/\/www.transceleratebiopharmainc.com\/gcp-training-attestation\/\" target=\"_blank\" rel=\"noopener noreferrer\">TransCelerate<\/a> can also be used.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<h2>Funding Organization Requirements<\/h2>\n<p>Currently, the only funding organization that requires that researchers complete GCP training is the National Institutes of Health.<\/p>\n<div class=\"accordion \" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">National Institutes of Health (NIH)<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p><a href=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-16-148.html\" target=\"_blank\" rel=\"noopener noreferrer\">Principal Investigators and clinical trial staff<\/a> who work on new and ongoing NIH-funded clinical trials must complete training in Good Clinical Practice (GCP) to be renewed every 3 years.<\/p>\n<p>For more information see UW&#8217;s <a href=\"https:\/\/www.washington.edu\/research\/policies\/faq-good-clinical-practice-training-2\/\">Frequently Asked Questions<\/a>.<br \/>\n<strong>Training Options<\/strong>:<\/p>\n<ul>\n<li>The <a href=\"https:\/\/www.washington.edu\/research\/hsd\/training\/required-training\/web-based-citi-training\/\">CITI Program<\/a> offers two online options that are free if you are affiliated with  91探花or collaborating with someone who is affiliated with UW.\n<ul>\n<li>4 &#8211; 6 hour online course tailored to drug and device trials<\/li>\n<li>2-3 hour course tailored to behavioral trials (this is the same content offered by the Society of Behavioral Medicine)<\/li>\n<\/ul>\n<\/li>\n<li>If you complete either CITI Good Clinical Practice course, you will automatically be enrolled in the refresher course 180 days before the training expires.<\/li>\n<li>The National Institutes of Health offers two, free online courses at:\n<ul>\n<li><a href=\"http:\/\/gcplearningcenter.niaid.nih.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">NIAID GCP Learning Center<\/a>, appropriate for all clinical trials<\/li>\n<li><a href=\"https:\/\/gcp.nidatraining.org\/\">NIDA Clinical Trials Network<\/a>, tailored to drug and behavioral trials<\/li>\n<\/ul>\n<\/li>\n<li>Training provided by industry partners and recognized by <a href=\"http:\/\/www.transceleratebiopharmainc.com\/gcp-training-attestation\/\" target=\"_blank\" rel=\"noopener noreferrer\">TransCelerate<\/a> can also be used to meet requirements.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<h2>Collaborating Institution Requirements<\/h2>\n<p> 91探花researchers who work with collaborating institutions as part of a research study may be required to complete training in order to meet that institution\u2019s requirements. Check with the collaborating organization to confirm their requirements. Common collaborators:<\/p>\n<ul>\n<li><a href=\"https:\/\/extranet.fredhutch.org\/en\/u\/irb\/training\/good-clinical-practice.html\" target=\"_blank\" rel=\"noopener noreferrer\">Fred Hutchinson Cancer Center<\/a><\/li>\n<li><a href=\"https:\/\/www.seattlechildrens.org\/research\/resources\/institutional-review-board\/training\/\" target=\"_blank\" rel=\"noopener noreferrer\">Seattle Children&#8217;s<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Researchers working in behavioral or biomedical clinical research must sometimes complete training in Good Clinical Practice (GCP) in order to meet the requirements of the organizations&#8230;<\/p>\n","protected":false},"author":158,"featured_media":0,"parent":9046,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-9054","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - 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