{"id":531,"date":"2010-04-29T11:23:24","date_gmt":"2010-04-29T15:23:24","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/crro\/?page_id=531"},"modified":"2026-08-17T11:34:58","modified_gmt":"2026-08-17T15:34:58","slug":"pi-role-training","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/crro\/training-education\/pi-role-training\/","title":{"rendered":"The Principal Investigator Role: What Every New and Seasoned PI Needs to Know about the Conduct and Oversight of Clinical Research"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">The Principal Investigator Role training is designed for those serving as Principal Investigators and will specifically address a PI&#8217;s oversight responsibilities for the conduct and management of research. The training utilizes <\/span><a href=\"https:\/\/www.ich.org\/page\/efficacy-guidelines\"><span style=\"font-weight: 400;\">International Conference for Harmonisation<\/span><\/a><span style=\"font-weight: 400;\"> standards on <\/span><a href=\"https:\/\/database.ich.org\/sites\/default\/files\/E6_R2_Addendum.pdf\"><span style=\"font-weight: 400;\">Good Clinical Practice (ICH-GCP)<\/span><\/a><span style=\"font-weight: 400;\"> and the <\/span><a href=\"https:\/\/mrctcenter.org\/clinical-trial-competency\/\"><span style=\"font-weight: 400;\">Joint Task Force for Clinical Trial Competency<\/span><\/a><span style=\"font-weight: 400;\"> as the structure for topics discussed.<\/span><\/p>\n<h5 style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\"><strong>Register for the PI Training<\/strong><\/h5>\n<ul>\n<li aria-level=\"1\"><a href=\"https:\/\/redcap.link\/89cs6vr0\" target=\"_blank\" rel=\"noopener\"><strong>Friday, November 13, 2026, 8-11:30 am<\/strong><\/a><\/li>\n<li aria-level=\"1\"><a href=\"https:\/\/redcap.bumc.bu.edu\/surveys\/?s=79AX4W94E7EAJNAF\" target=\"_blank\" rel=\"noopener\">Tuesday, April 14, 2026, 8-11:30 am<\/a><\/li>\n<li aria-level=\"1\"><a href=\"https:\/\/redcap.bumc.bu.edu\/surveys\/?s=HK3K4TMK8Y9TEXDD\" target=\"_blank\" rel=\"noopener\">Wednesday, July 14, 2025, 8-11:30 am<\/a><\/li>\n<\/ul>\n<ul><\/ul>\n<h4 style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\"><strong>Who Should Take This Training<\/strong><\/h4>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">BU Medical Campus, BMC, BMC Brighton, BMC South and Boston HealthNet Community Health Center investigators only. Individuals from external organizations or institutions are unable to attend.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Current Principal Investigators<\/span>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">New to research<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">New to BMC or BU Medical Campus<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Experienced investigators interested in a refresher<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Those who are interested in becoming a Principal Investigator in the future including fellows<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">All are welcome from various educational and professional backgrounds including medical, dental, nursing, and public health<\/span><\/li>\n<\/ul>\n<h2 style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\"><strong>What You Need to Know<\/strong><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The course is offered 2-3 times per year<\/span><\/li>\n<li aria-level=\"1\">Training is one 3.5 hour session<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Registration closes 48 hours prior to training start<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Successful completion towards GCP Certification is fulfilled by the following requirements.\u00a0<\/span>\n<ul>\n<li><span style=\"font-weight: 400;\">Attendance of 80% of the session<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Post-training quiz score of at least 70%<\/span><\/li>\n<\/ul>\n<\/li>\n<li aria-level=\"1\">Includes Pre and Post Training Quizzes to assess learning and provide appropriate Good Clinical Practice certification.<\/li>\n<li><span style=\"font-weight: 400;\">Successful completion of this training fulfills the <\/span><a href=\"https:\/\/www.bumc.bu.edu\/ohra\/required-training\/good-clinical-practice-gcp-certification\/\"><span style=\"font-weight: 400;\">BMC\/BU Medical Campus HRPP GCP training requirement<\/span><\/a><span style=\"font-weight: 400;\"> for 3 years.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">This training is currently offered over Zoom and intended to provide direct interaction and learning. <\/span><i><span style=\"font-weight: 400;\">Video recordings will not be made available for those who cannot attend. No exceptions will be made<\/span><\/i><\/li>\n<\/ul>\n<h5 style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\"><strong>Educational Objectives<\/strong><\/h5>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Describe the responsibilities and oversight requirements of a Principal Investigator and Investigator-Sponsors<\/span><\/li>\n<li aria-level=\"1\">Describe regulations and Good Clinical Practice that govern research<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Explain the purpose of IRB and criteria for IRB review<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identify strategies to ensure protocol and safety plan adherence<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identify best practices in consent and screening processes<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identify study documentation best practices that fulfill regulatory requirements and support high quality research<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Describe the purpose of monitoring, evaluation and reporting of adverse events and unanticipated problems, and identify strategies to adhere to these requirements<\/span><\/li>\n<\/ul>\n<ul><\/ul>\n<hr \/>\n<p><i><span style=\"font-weight: 400;\">Questions about which training to take?<\/span><\/i><a href=\"https:\/\/www.bumc.bu.edu\/crro\/comparison-between-pi-and-fundamentals-training\/\"> <i><span style=\"font-weight: 400;\">Review a comparison between Fundamentals and PI Training.<\/span><\/i><\/a><br \/>\n<i><span style=\"font-weight: 400;\">Questions about any of the above information? <\/span><\/i><a href=\"mailto:crro@bu.edu\"><i><span style=\"font-weight: 400;\">Contact us!<\/span><\/i><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Principal Investigator Role training is designed for those serving as Principal Investigators and will specifically address a PI&#8217;s oversight responsibilities for the conduct and management of research. The training utilizes International Conference for Harmonisation standards on Good Clinical Practice (ICH-GCP) and the Joint Task Force for Clinical Trial Competency as the structure for topics [&hellip;]<\/p>\n","protected":false},"author":1250,"featured_media":0,"parent":2445,"menu_order":7,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/531"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/users\/1250"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/comments?post=531"}],"version-history":[{"count":54,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/531\/revisions"}],"predecessor-version":[{"id":7171,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/531\/revisions\/7171"}],"up":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/2445"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/media?parent=531"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}