{"title":"Financial Disclosure: New FDA Draft Guidance for Clinical Investigator Reporting","description":"\u003cp\u003e\u003cimg title=\"Course Description\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/CourseDescription.jpg?n=5553\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eThe requirements outlined in the federal regulations governing the disclosure of financial interests by Clinical Investigators permit sponsors and the FDA to assess the potential for bias in research by review of specific information. The integrity of data obtained from clinical research studies depends in large part on the ability to ensure that the data is free from bias or conflict of interest. Federal regulations require not only disclosure of this information, but development and implementation of plans to mitigate and manage any perceived or real conflict. This web seminar will focus on clinical research professionals’ responsibilities for disclosing, reporting, and managing potential conflicts that may impact the outcome of the study and the FDA’s review. Discussion will include review of sponsors’ due diligence requirements, regulatory authorities’ refined focus on financial information in clinical research, and the FDA’s actions and recommendations for ensuring requirements are met.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Learning Objectives\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/LearningObjectives.jpg?n=4499\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eDiscuss the requirements and limitations of the Form FDA 3454\u003c\/li\u003e\n\u003cli\u003eReview reporting requirements in the “real world”\u003c\/li\u003e\n\u003cli\u003eExamine acceptable management\/mitigation plans\u003c\/li\u003e\n\u003cli\u003eDefine and discuss Significant Payments of Other Sorts (SPOOS)\u003c\/li\u003e\n\u003cli\u003eEvaluate requirements for clinical research conducted by foreign investigators\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/WhoShouldAttend.jpg?n=7655\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eClinical Research Associates\u003c\/li\u003e\n\u003cli\u003eClinical Investigators\u003c\/li\u003e\n\u003cli\u003eProject Managers\u003c\/li\u003e\n\u003cli\u003eClinical Research Professionals involved in site and IRB assessment and\/or selection\u003c\/li\u003e\n\u003cli\u003eProfessionals from Academia involved in the oversight, documentation, and conduct of clinical research\u003c\/li\u003e\n\u003cli\u003eIRB Members, IRB Professionals, and Institutional Officials involved in oversight of clinical research\u003c\/li\u003e\n\u003cli\u003eConflict of Interest Officers and Committee Members\u003c\/li\u003e\n\u003cli\u003eGCP-Focused Regulatory Affairs Professionals\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/Instructor.jpg?n=9798\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eElizabeth Ronk Nelson, M.P.H.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cfont color=\"#800080\"\u003eClick here for complete trainer biographies\u003c\/font\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/a\u003e \u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Registration Fees\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/RegistrationFees.jpg?n=5717\" border=\"0\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e$695\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eIncludes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Accreditation Information\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/AccreditationInformation.jpg?n=3445\" border=\"0\"\u003e\u003cbr\u003e\u003cbr\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-11-062-L01-P. Released: 9\/11. \u003c\/p\u003e\n\u003cp align=\"center\" class=\"Abstract\"\u003e\u003cfont color=\"#0000ff\"\u003e\u003cstrong\u003eHold this course at your company! \u003c\/strong\u003e\u003c\/font\u003e\u003cfont color=\"#0000ff\"\u003e\u003cstrong\u003eFor more information, contact Naila Ganatra at (215) 413-2471.\u003c\/strong\u003e\u003c\/font\u003e \u003c\/p\u003e\n\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e\n\u003cp align=\"left\" class=\"Abstract\"\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/financial-disclosure-new-fda-draft-guidance-for-clinical-investigator-reporting.oembed","provider":"Barnett International ","version":"1.0","type":"link"}