{"id":26615,"date":"2021-01-08T15:52:15","date_gmt":"2021-01-08T20:52:15","guid":{"rendered":"https:\/\/www.bu.edu\/research\/?page_id=26615"},"modified":"2026-05-11T10:38:05","modified_gmt":"2026-05-11T14:38:05","slug":"clinical-trial-agreements","status":"publish","type":"page","link":"https:\/\/www.bu.edu\/research\/collaboration-partnership\/industry-collaboration\/clinical-trial-agreements\/","title":{"rendered":"Clinical Trial Agreements"},"content":{"rendered":"<p>The industry contracting group manages the negotiation, execution and account setup for clinical trials, including industry-sponsored or investigator-initiated protocols as well as trials initiated by non-industry entities (e.g., universities).<\/p>\n<p>BU researchers should contact the industry contracting group at <a href=\"mailto:industry@bu.edu\">industry@bu.edu<\/a> as early in the process as possible; preferably as soon as an industry study has been identified or as soon as a sponsor or contract research organization has approached a BU researcher for potential participation as a clinical trial site.<\/p>\n<p>A typical industry clinical trial agreement request should proceed according to the following pathway:<\/p>\n<div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h3 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">Preliminary step, CDA negotiation<\/h3><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<ol>\n<li>Documentation Submission to Corporate Research &#038; Contracting by Principal Investigator (PI)\n<ul>\n<li>DA Request Form<\/li>\n<li>Draft Sponsor CDA<\/li>\n<\/ul>\n<li>Contract Negotiation by ICA\n<li>Acknowledgment of document receipt<\/li>\n<li>Review, Redline &amp; Negotiate CTA with sponsor<\/li>\n<\/ol>\n<p><\/div>\n<\/div>\n\n<div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h3 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">Documentation Submission to Corporate Research & Contracting by Principal Investigator (PI)<\/h3><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<ul>\n<li><a href=\"https:\/\/www.bu.edu\/research\/ethics-compliance\/conflicts-of-interest\/\" title=\"Conflict of Interest\">Conflict of Interest Form (COI)<\/a><\/li>\n<li>Copy of Assurances (IRB, IACUC, etc.); if pending review, please provide proposal number and submission date<\/li>\n<li>Draft Sponsor CTA &amp; Sponsor Contact Information<\/li>\n<li>Preliminary Budget<\/li>\n<li><a href=\"https:\/\/www.bu.edu\/research\/forms-policies\/bubmc-proposal-summary-form-psf\/\" title=\"BU\/BMC Proposal Summary Form (PSF)\">Proposal Summary Form (PSF)<\/a><\/li>\n<\/ul>\n<p><\/div>\n<\/div>\n\n<div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h3 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">Contract Negotiation by Corporate Research & Contracting<\/h3><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<ol>\n<li>Acknowledgement of document receipt<\/li>\n<li>Review, Redline &amp; Negotiate CTA with sponsor<\/li>\n<li>Informed Consent Forms Subject Injury Language<\/li>\n<\/ol>\n<p><\/div>\n<\/div>\n\n<div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h3 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">Parallel Actions by PI<\/h3><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<ol>\n<li>Budget negotiation:\n<ul>\n<li>BMC \u2013 pricing and Medicare Coverage Analysis (MCA), required for studies using hospital resources<\/li>\n<li>Sponsor &#8211; PI is responsible for negotiating budgets with the sponsor<\/li>\n<\/ul>\n<li>IRB Submission<\/li>\n<\/ol>\n<p><\/div>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"<p>The industry contracting group manages the negotiation, execution and account setup for clinical trials, including industry-sponsored or investigator-initiated protocols as well as trials initiated by non-industry entities (e.g., universities). BU researchers should contact the industry contracting group at industry@bu.edu as early in the process as possible; preferably as soon as an industry study has been [&hellip;]<\/p>\n","protected":false},"author":15731,"featured_media":0,"parent":25122,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/pages\/26615"}],"collection":[{"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/users\/15731"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/comments?post=26615"}],"version-history":[{"count":9,"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/pages\/26615\/revisions"}],"predecessor-version":[{"id":63072,"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/pages\/26615\/revisions\/63072"}],"up":[{"embeddable":true,"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/pages\/25122"}],"wp:attachment":[{"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/media?parent=26615"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}