{"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":"2026-09-02T08:54:28","modified_gmt":"2026-09-02T12:54:28","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;\">The Fundamentals training is designed for research staff and covers current regulations and best practices as well as providing tools and resources for successful study implementation. The training is case-based and interactive, covering core principles of <\/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 R3)<\/span><\/a><span style=\"font-weight: 400;\"> the regulatory framework governing clinical research (including FDA and OHRP\/HHS requirements), and the <\/span><span style=\"font-weight: 400;\"><a href=\"https:\/\/mrctcenter.org\/clinical-trial-competency\/\" target=\"_blank\" rel=\"noopener\">Joint Task Force for Clinical Trial Competency<\/a>, <\/span><span style=\"font-weight: 400;\">as the structure for topics and competencies discussed.<\/span><\/p>\n<h4 style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\"><strong>Register for the Fundamentals Training<\/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 (<em><span style=\"font-weight: 400;\">Registration closes 48 hours prior to training start<\/span><\/em><span style=\"font-weight: 400;\">)<\/span>\n<ul>\n<li><strong>September 2026, Wednesdays &#8211; 2, 9, 16, 23, 30, 8:30-11:00 am<\/strong><\/li>\n<li><a href=\"https:\/\/redcap.link\/gqpg2ezo\" target=\"_blank\" rel=\"noopener\"><strong>January 2027, Tuesdays and Thursdays &#8211; January 12, 14, 19, 21, 26,\u00a0<\/strong><strong>8:30-11:00 am<\/strong><\/a><\/li>\n<li><a href=\"https:\/\/redcap.link\/90i216j3\" target=\"_blank\" rel=\"noopener\"><strong>March 2027<\/strong>, <strong>Wednesdays &#8211; March 3, 10, 17, 24, 31,<\/strong>\u00a0<strong>8:30-11:00 am<\/strong><\/a><\/li>\n<li><a href=\"https:\/\/redcap.link\/eb1q3lft\" target=\"_blank\" rel=\"noopener\"><strong>June 2027, Tuesdays and Thursdays &#8211; June 1, 3, 8, 10, 15, 8:30-11:00 am<\/strong><\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\"><strong>Who Should Take This Training<\/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, BMC, BMC Brighton, BMC South and Boston HealthNet Community Health Centers staff faculty and 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<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<p><span style=\"text-decoration: underline;\"><strong>What You Need to Know<\/strong><\/span><\/p>\n<ul>\n<li aria-level=\"1\">All sessions are scheduled for 8:30-11am<\/li>\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;\"><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.\u00a0<\/span><\/i><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sessions are offered over Zoom and intended to provide direct interaction and learning. As this is an interactive training, cameras should be on. <\/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<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 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<li>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<\/ul>\n<ul><\/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>Describe the regulations that guide your research<\/li>\n<li>Explain best practices for IRB submissions<\/li>\n<li>Identify the regulations and guidance that inform and guide the conduct of your study<\/li>\n<li>Describe and explain Clinical Research Professional (CRP) responsibilities from study start-up to study completion<\/li>\n<li>Describe the responsibilities and oversight of the Principal Investigator (PI), Sponsor and study team<\/li>\n<li>Apply the elements of the ICH Good Clinical Practice guidelines to your research studies<\/li>\n<li>List requirements and best practices for informed consent<\/li>\n<li>Describe the steps for conducting a study: initiation, activities, closure<\/li>\n<li>Identify best practices in the recruitment and screening of research subjects<\/li>\n<li>Explain why and how to best document your study<\/li>\n<li>Describe the monitoring, evaluation and reporting of adverse events and unanticipated problems<\/li>\n<li>Institute a plan of self- assessments to support audit-readiness and validity and integrity of study data<\/li>\n<\/ul>\n<ul>\n<li aria-level=\"1\" style=\"list-style-type: none;\">\n<ul><\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400;\">Please 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><\/p>\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 Fundamentals training is designed for research staff and covers current regulations and best practices as well as providing tools and resources for successful study implementation. The training is case-based and interactive, covering core principles of International Conference for Harmonisation standards on Good Clinical Practice (ICH-GCP R3) the regulatory framework governing clinical research (including FDA [&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":7179,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/219\/revisions\/7179"}],"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}]}}