{"id":2437,"date":"2016-07-06T13:30:28","date_gmt":"2016-07-06T17:30:28","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/crro\/?page_id=2437"},"modified":"2025-08-12T12:00:55","modified_gmt":"2025-08-12T16:00:55","slug":"research-and-regulatory-consultations","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/crro\/research-and-regulatory-consultations\/","title":{"rendered":"Research and Regulatory Consultations"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Through consultations, the CRRO provides expert review and guidance for investigators and research staff. Consultations can be requested at any point during the life of a study and for any reason. Any member of a study team or research staff member may request a consultation. The IRB may request that the study team complete a consultation as part of their study submission review.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For simple questions, consultations can be completed over email but most will generally involve at least one meeting or more depending upon the complexity of the request.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For investigators with funding or submission deadlines, it is recommended that consultations are requested early in the process to best meet those deadlines.<\/span><\/p>\n<p><em>To request a consultation, <a href=\"https:\/\/webcamp.bumc.bu.edu\/webcampv5\/SourceCode\/WebCAMP_CoreTracking\/ResourceRequest\/NoLogin\/RequestResources.cfm?SIGNATURE=0C03000A030509010F03000104&amp;REQUESTFORM=3&amp;DSN=1&amp;RootURL=https$$webcamp.bumc.bu.edu$webcampv5$SourceCode$\">complete the Request CRRO Services form<\/a>. A response can be expected within 5 business days.<\/em><\/p>\n<h2 style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\">Common Consultation Requests<\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Required Review for Investigator-Initiated Clinical Trials<\/span>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Per<\/span><a href=\"https:\/\/www.bumc.bu.edu\/ohra\/hrpp-policies\/hrpp-policies-procedures\/#6.2.1.2\"> <span style=\"font-weight: 400;\">HRPP policy 6.2.1.2<\/span><\/a><span style=\"font-weight: 400;\">, a study meeting the definition of a clinical trial that is initiated by the PI at Boston Medical Center or Boston University Medical Campus must complete a CRRO consultation prior to IRB review<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">IRB Submissions<\/span>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Could include review of INSPIR application, protocol, consent, or any other study-specific document<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Could be an initial submission, CAPA submission, or protocol amendments<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Could include review of stipulations from any IRB review<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Study Implementation: either before or after start of recruitment and enrollment<\/span>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Recruitment plans either for feasibility or slower than expected enrollment rates<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Consenting processes<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Eligibility determinations and documentation<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Adverse events monitoring, assessing, and reporting<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">General study documentation include setup of participant or regulatory files<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">BMC SOP Guidance<\/span>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Implementation and completion of standards set in Quality Management and Research Team Competency SOPs<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">General review and compliance recommendations for any SOP<\/span><\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">FDA Guidance<\/span>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Responsibilities of a Sponsor-Investigators holding an IND or IDE<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"2\"><span style=\"font-weight: 400;\">Review of initial or ongoing submissions<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h3 style=\"text-decoration: underline; font-size: 16px; margin-bottom: 2px;\">Depending on the type of consultation, benefits could include:<\/h3>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Shortened IRB-review time<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">More effective recruitment<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Fewer monitor or audit findings<\/span><\/li>\n<\/ul>\n<hr \/>\n<p><em><span>For more information or questions, please contact us at\u00a0<\/span><a href=\"mailto:crro@bu.edu\"><span>crro@bu.edu<\/span><\/a><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Through consultations, the CRRO provides expert review and guidance for investigators and research staff. Consultations can be requested at any point during the life of a study and for any reason. Any member of a study team or research staff member may request a consultation. The IRB may request that the study team complete a [&hellip;]<\/p>\n","protected":false},"author":1250,"featured_media":0,"parent":0,"menu_order":15,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/2437"}],"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=2437"}],"version-history":[{"count":26,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/2437\/revisions"}],"predecessor-version":[{"id":6965,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/2437\/revisions\/6965"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/media?parent=2437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}