{"id":11369,"date":"2019-01-31T16:19:33","date_gmt":"2019-01-31T15:19:33","guid":{"rendered":"http:\/\/gcp.igina.me\/gcp-central-nieuws-nl\/preventing-duplicate-gcp-training-does-it-work\/"},"modified":"2019-03-27T19:03:50","modified_gmt":"2019-03-27T18:03:50","slug":"preventing-duplicate-gcp-training-does-it-work","status":"publish","type":"post","link":"https:\/\/gcpcentral.com\/nl\/gcp-central-nieuws-nl\/preventing-duplicate-gcp-training-does-it-work\/","title":{"rendered":"Preventing duplicate GCP training \u2013 does it work?"},"content":{"rendered":"<p><strong><em><span style=\"vertical-align: inherit;\">In the world of Good Clinical Practice, what does it mean when a Training Provider claims to have &#8220;TransCelerate acknowledged&#8221; GCP training? Our questionnaire shows not many investigators, CRAs and site staff are aware of the existence and added value.<\/span><\/em> <\/strong><\/p>\n<h2><span style=\"vertical-align: inherit;\">What is TransCelerate?<\/span><\/h2>\n<p><a href=\"http:\/\/www.transceleratebiopharmainc.com\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">TransCelerate<\/span><\/span><\/a><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\"> is a non-profit organization that creates effective, innovative solutions for the biopharmaceutical industry.\u00a0Member companies, who are biotech and pharmaceutical companies, have helped develop guidelines to give hospitals and their investigators peace of mind when it comes to choosing GCP Training Providers. All providers who can measure their <\/span><\/span><a href=\"http:\/\/www.transceleratebiopharmainc.com\/wp-content\/uploads\/2017\/03\/GCP-MR-Minimum-Criteria-R2_FINAL.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">minimum criteria<\/span><\/span><\/a><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\"> are provided in a list, which should be considered by ICH GCP training.<\/span><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/gcpcentral.com\/\"><span style=\"vertical-align: inherit;\">GCP Central<\/span><\/a><span style=\"vertical-align: inherit;\"> is proud to be one of the early supporters of the TransCelerate GCP mutual recognition program. Our first TransCelerate acknowledged ICH-GCP training course launched in March 2013, less than one year after the initiative was born.<\/span><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">Seven years after the implementation of the GCP mutual recognition program and eleven approved courses later, we are excited to announce that GCP Central has received a renewal of the TransCelerate acknowledgment as necessary after the ICH-GCP R2 update of our courses. This update was essential in order to remain compliant and up to date.<\/span><\/span><\/p>\n<h2><span style=\"vertical-align: inherit;\">GCP Central and TransCelerate<\/span><\/h2>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">We want to reduce the time spent on GCP training. We believe that initiatives like TransCelerate make the lives of researchers, clinicians, and their staff, easier. This is by increasing the efficiency of (and preventing bureaucracy) during site initiations and trials.<\/span><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">Being a listed Training Provider on the TransCelerate BioPharma website with various approved courses ensures that our trained investigators and site personnel do not have GCP training at the beginning of each trial. Instead, it is unnecessary to repeat a GCP course within the trial, especially when you use our <a href=\"https:\/\/gcpcentral.com\/gcp-central-nieuws\/5-important-reasons-to-extend-your-mygcp-account\/\">continuous <\/a><\/span>GCP learning model.<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">With investigators conducting trials for multiple sponsors, our universally accepted GCP training program does not have to be repeated. Researchers can get out of business at hand &#8211; conducting quality research and improving human health.<\/span><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">In October 2018 we have Conducted internal company audit and micro questionnaire with 250 clinical research professionals who are both on the internet and on my LinkedIn learning platform. The goal was simple, we wanted to check whether the TransCelerate program goals are sufficient.<\/span><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">We presented our findings in November 2018 at the <\/span><\/span><a href=\"https:\/\/www.nvfg.nl\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">NVFG<\/span><\/span><\/a><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\"> presentation at the ClinOps meeting.\u00a0<\/span><\/span><\/p>\n<h2><span style=\"vertical-align: inherit;\">Key Findings<\/span><\/h2>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">More than 50% of respondents said they had to attend 2 or more GCP training sessions in the last three years. A small group of 14 respondents had to take more than 5 GCP training in the previous three years. \u00a0<\/span><\/span><em><b><span style=\"vertical-align: inherit;\">This is 2 per year. Duplicating GCP training is unnecessary and precisely what TransCelerate would like to prevent.<\/span><\/b><\/em><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">85% of our respondents working in hospitals are not familiar with TransCelerate.<\/span><\/span><\/li>\n<\/ul>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">37.5% of respondents think the goal of TransCelerate is to provide certification to GCP Training Providers or perform a quality check on training contents. (81% of this 37.5% is work in hospitals or universities)<\/span><\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">74% of respondents do not check for TransCelerate acknowledgment when choosing a GCP training\/training provider. Of the people who do not test for acknowledgment work at a hospital or university.<\/span><\/span><\/li>\n<\/ul>\n<h2><span style=\"vertical-align: inherit;\">Key Points<\/span><\/h2>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">For us, the main point we took away from the survey was that the GCP Mutual Recognition program or TransCelerate is not aware of the GCP Mutual Recognition program. This information is critical, the TranCelerate member companies and the TransCelerate organization need to spread the work and the benefits.<\/span><\/span><\/p>\n<h2><span style=\"vertical-align: inherit;\">How can we make better use of the TransCelerate Mutual Recognition Initiative?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">In our opinion, to build upon the current success of TransCelerate, all pharmaceutical, and biotech companies should be motivated to be part of TransCelerate. To date, <\/span><\/span><a href=\"http:\/\/www.transceleratebiopharmainc.com\/gcp-training-attestation\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">nineteen pharmaceutical companies are part of TransCelerate and many other organizations have a partnership with TransCelerate providing valuable insights.<\/span><\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">Mentioning the TransCelerate membership, and its implications, in SOPs and Policies could increase the understanding and adherence to the TransCelerate Initiatives. This helps to prevent duplication of GCP training by site staff and clinicians, and increases the speed of initiation of sites, helping to get research results and data quicker. <\/span><\/span><span style=\"vertical-align: inherit;\"><span style=\"font-weight: 400;\">We should also be investigators, clinicians and site staff aware of the existence and goal of TransCelerate Mutual Recognition.<\/span><\/span><\/p>\n<p><span style=\"vertical-align: inherit;\"><span style=\"font-weight: 400;\">We encourage TransCelerate, the GCP Training Providers, pharmaceuticals, biotech companies, and all partners such as CROs to spread awareness to improve clinical trials and motivated site staff. .<\/span><span style=\"font-weight: 400;\">The success of this initiative is in the collaboration between sponsors and investigators, let&#8217;s help each other to make the process more efficient.<\/span><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">The findings of our mini questionnaire prove that more needs to be done to support and continue the innovative work of TransCelerate and similar projects. <\/span><\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">GCP Central likes to be at the forefront of changes in the clinical research industry. \u00a0We want to make clinical trials smarter and faster. By being TransCelerate acknowledged, helping to spread the word among investigators, and by being actively involved in initiatives.<\/span><\/span><\/p>\n<p><span style=\"font-weight: 400;\"><span style=\"vertical-align: inherit;\">Want to see more about our questionnaire results and the opportunities we see for TransCelerate? Read it in our next blog about TransCelerate.<\/span><\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the world of Good Clinical Practice, what does it mean when a Training Provider claims to have &#8220;TransCelerate acknowledged&#8221; GCP training? Our questionnaire shows not many investigators, CRAs and site staff are aware of the existence and added value. What is TransCelerate? TransCelerate is a non-profit organization that creates effective, innovative solutions for the [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":11314,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[54],"tags":[96,87,88,94,90],"class_list":["post-11369","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gcp-central-nieuws-nl","tag-duplicate-training-nl","tag-gcp-nl","tag-gcp-central-nl","tag-gcp-training-nl","tag-transcelerate-nl"],"_links":{"self":[{"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/posts\/11369","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/comments?post=11369"}],"version-history":[{"count":0,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/posts\/11369\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/media\/11314"}],"wp:attachment":[{"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/media?parent=11369"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/categories?post=11369"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/tags?post=11369"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}