{"id":49674,"date":"2014-06-10T00:00:00","date_gmt":"2014-06-10T05:00:00","guid":{"rendered":"https:\/\/www.unmc.edu\/newsroom\/2014\/06\/10\/gcp-training-required-for-clinical-trial-personnel\/"},"modified":"2022-08-29T14:45:53","modified_gmt":"2022-08-29T19:45:53","slug":"gcp-training-required-for-clinical-trial-personnel","status":"publish","type":"post","link":"https:\/\/www.unmc.edu\/newsroom\/2014\/06\/10\/gcp-training-required-for-clinical-trial-personnel\/","title":{"rendered":"GCP training required for clinical trial personnel"},"content":{"rendered":"<div class=\"panel body-content\"><div class=\"panel__container\"><p>\nAll personnel conducting human-subject research (HSR) overseen by the UNMC Institutional Review Board (IRB) must complete initial and continuing education regarding protection of subjects&#039; rights and welfare.<\/p>\n<p>\nThis training is accomplished in part through the Collaborative Institutional Training Initiative (CITI), a web-based training program. In the past, the CITI Human Subject Research (HSR) course was required and the Good Clinical Practice (GCP) course was optional.<\/p>\n<p>\nGuided by international ethical and scientific quality standards, numerous countries have adopted the ICH-GCP guidelines. Many clinical trial sponsors are now requiring compliance with the ICH-GCP standard, which generally includes additional training for research personnel.<\/p>\n<p>\nIn the ongoing effort to provide clinical investigators and research personnel with high quality training, Vice Chancellor for Research Jennifer Larsen, M.D., and the IRB have recently mandated the completion of the GCP modules in addition to the currently required HSR modules for the CITI course. At the time of initial CITI training or re-certification, all individuals involved in the conduct of clinical trials involving drugs and\/or devices will be required to take the &quot;Group 1 Biomedical Course for Clinical Trials Involving Drugs and\/or Devices&quot; course. The GCP modules have been incorporated into that course.<\/p>\n<p>\nThis GCP course meets the minimum training requirements for many sponsors. By providing the CITI Completion Report to those sponsors, often no additional GCP training will required. Click <a href=\"http:\/\/www.transceleratebiopharmainc.com\/about\/meet-the-members\/\">here<\/a> to see the list of sponsors that accept this course.<\/p>\n<p>\nInvestigators and research personnel not involved in the conduct of clinical trials involving drugs and\/or devices are not required to complete the GCP modules. At the time of initial CITI training or re-certification, those individuals will complete &quot;Group 2 Biomedical studies not classified as clinical trials involving drugs or devices.&quot;<\/p>\n<p>\nIf you have any questions regarding CITI training, contact Jenny Kucera, jikucera@unmc.edu or (402) 559-6119. Additional information and CITI instructions can be found on the <a href=\"http:\/\/www.unmc.edu\/irb\/\">IRB website<\/a>.<\/p>\n<div style=\"display: none;\"><a rel=\"nofollow\" href=\"\/secure-location.php\" title=\"dKw oMw rNisgY X P A XLM\">dKw oMw rNisgY X P A XLM<\/a><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>New training in clinical practice is now mandatory for personnel conducting human-subject research.<\/p>\n","protected":false},"author":27,"featured_media":49675,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-49674","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","department-unmc-today-todays-headlines","department-vice-chancellor-research"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>GCP training required for clinical 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