{"id":219,"date":"2010-01-13T11:35:47","date_gmt":"2010-01-13T16:35:47","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/crro\/?page_id=219"},"modified":"2026-03-30T11:30:24","modified_gmt":"2026-03-30T15:30:24","slug":"fundamentals","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/crro\/training-education\/fundamentals\/","title":{"rendered":"Fundamentals in the Conduct of Clinical Research: BMC and BU Medical Campus Research Professional Staff Training"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Offered quarterly, the Fundamentals training is designed for research study staff and covers current regulations and best practices as well as providing tools and resources for successful study implementation. 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 and competencies discussed.<\/span><\/p>\n<p>Detailed information on the Fundamentals training is below. <span style=\"color: #ff0000;\"><strong>To register for our <span style=\"text-decoration: underline;\">June Fundamentals training<\/span>, scroll to the bottom of the page.<\/strong><\/span><\/p>\n<p><strong>Quarterly Offerings \u2013 All sessions are scheduled for 8:30-11am<\/strong><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Training sessions of 2.5 hours each week for a total of 12.5 hours<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Registration closes 48 hours prior to training start<\/span><\/li>\n<li>Includes Pre and Post Training Quizzes to assess learning and provide appropriate Good Clinical Practice certification<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\"><span style=\"text-decoration: underline;\">Session 1 must be attended in full<\/span> to be able to continue with the rest of the sessions. If Session 1 is missed, your registration will be canceled.<\/span><i><span style=\"font-weight: 400;\"> No exceptions will be made as Session 1 is the foundation for all further sessions. It is your responsibility to plan appropriately to attend these sessions.\u00a0<\/span><\/i><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sessions are currently offered over Zoom and intended to provide direct interaction and learning. <\/span><em><span style=\"font-weight: 400;\">Video recordings will not be made available for those who cannot attend one or more sessions. <\/span><span style=\"font-weight: 400;\">No exceptions will be made.\u00a0<\/span><\/em><\/li>\n<\/ul>\n<h5 style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\">Good Clinical Practice Certification Overview<i><span style=\"font-weight: 400;\"><\/span><\/i><\/h5>\n<ul>\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><span style=\"font-weight: 400;\">Successful completion towards GCP Certification is fulfilled by the following requirements. <\/span><i><span style=\"font-weight: 400;\">No exceptions will be made to these requirements.<\/span><\/i>\n<ul>\n<li><span style=\"font-weight: 400;\">Attendance of 80% of each 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<\/ul>\n<p style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\"><strong>Target Audience<\/strong><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">BU Medical Campus and BMC staff 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;\">Study team members including coordinators, research assistants, research nurses, or project managers<\/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 clinical research support staff interested in a refresher<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<ul><\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul><\/ul>\n<\/li>\n<\/ul>\n<ul><\/ul>\n<h4 style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\"><strong><strong>Educational Objectives<\/strong><\/strong><\/h4>\n<ul>\n<li>Discuss the regulations governing human subjects research and applicability to different studies<\/li>\n<li>Apply the elements of the ICH Good Clinical Practice guidelines<\/li>\n<li>Describe and explain Clinical Research Professional responsibilities from study start-up to study completion<\/li>\n<li>Identify steps to obtain the necessary approvals to conduct clinical research at BMC and BU Medical Campus<\/li>\n<li>Identify best practices in the recruitment, screening, and informed consent of research subjects<\/li>\n<li>Identify strategies for managing and developing study documentation that fulfill regulatory requirements and support high quality research<\/li>\n<li>Describe appropriate monitoring for adverse events, including identification, documentation, and reporting<\/li>\n<\/ul>\n<h4 style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\"><strong><strong>Register for the Fundamentals Training<\/strong><\/strong><span style=\"font-weight: 400;\"><\/span><\/h4>\n<ul>\n<li aria-level=\"1\">Save the dates on your calendar and register for these future Fundamentals training dates:\n<ul>\n<li><strong>Tuesdays and Thursdays \u2013 June 2, 4, 9, 11, 16, 8:30-11:00am<\/strong><span style=\"font-weight: 400;\">. <a href=\"https:\/\/redcap.bumc.bu.edu\/surveys\/?s=K939N43JM33T3HTD\" target=\"_blank\" rel=\"noopener noreferrer\"><strong><span style=\"text-decoration: underline;\">Register here for the training.<\/span><\/strong><\/a>\u00a0Please email\u00a0<\/span><strong><a href=\"mailto:haltwies@bu.edu\" target=\"_blank\" rel=\"noopener\">snwarth@bu.edu<\/a><\/strong><span style=\"font-weight: 400;\"> with any questions regarding Fundamentals.<\/span><\/li>\n<li><span style=\"font-weight: 400;\"><span style=\"color: #ff0000;\"><strong>\u00a0Please use your BU or BMC email address to register.\u00a0 If you do not have one, please reach out to <a href=\"mailto:crro@bu.edu\">crro@bu.edu<\/a> to let us know.<\/strong><\/span><\/span><\/li>\n<\/ul>\n<\/li>\n<\/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>Offered quarterly, the Fundamentals training is designed for research study staff and covers current regulations and best practices as well as providing tools and resources for successful study implementation. 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 [&hellip;]<\/p>\n","protected":false},"author":1250,"featured_media":0,"parent":2445,"menu_order":6,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/219"}],"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=219"}],"version-history":[{"count":57,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/219\/revisions"}],"predecessor-version":[{"id":7096,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/219\/revisions\/7096"}],"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=219"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}