{"title":"Randomized Controlled Trials: Ethics, Consenting, Maintaining the Blind, and Protocol Adherence","description":"\u003cp\u003e\u003cimg title=\"Course Description\" border=\"0\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/CourseDescription.jpg?n=5553\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eCurrently, the FDA is making the case for Randomized Controlled Trials (RCTs) in evaluating Ebola therapies (NEJM Dec 18, 2014). The FDA is challenging industry and the medical community in the necessity of conducting scientifically valid trials and understanding the importance of the placebo effect. This web seminar will include an overview by a former FDA medical officer on the importance of learning how to “think like a regulator” especially during the consenting process, maintaining the blind, and protocol adherence. Case studies will be used to demonstrate the power of RCTs to achieve success. Bring your questions as you learn to see through the eyes of a regulator. Upon completion, learners will be able to better prepare investigators and sites for current study design challenges to fulfill both ethical and regulatory requirements.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Learning Objectives\" style=\"LINE-HEIGHT: 1.5em\" border=\"0\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/LearningObjectives.jpg?n=4499\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eDescribe the FDA’s latest approach to clinical investigations and additional challenges to auditing and monitoring RCT trials\u003c\/li\u003e\n\u003cli\u003eDetermine how Congressional action might affect your studies\u003c\/li\u003e\n\u003cli\u003eBecome a futurist thinker on the FDA\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" border=\"0\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/WhoShouldAttend.jpg?n=7655\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eClinical Research Coordinators\u003c\/li\u003e\n\u003cli\u003eClinical Research Associates\u003c\/li\u003e\n\u003cli\u003eInvestigators\u003c\/li\u003e\n\u003cli\u003eInstitutional Review Board\/Ethic Committee Members\u003c\/li\u003e\n\u003cli\u003eProject Managers\u003c\/li\u003e\n\u003cli\u003eDirectors\u003c\/li\u003e\n\u003cli\u003eQuality Assurance Professionals\u003c\/li\u003e\n\u003cli\u003eRegulatory Affairs Personnel\u003c\/li\u003e\n\u003cli\u003eAuditors\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" border=\"0\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/Instructor.jpg?n=9798\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eJerri Barden Perkins, M.D.\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\" border=\"0\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/RegistrationFees.jpg?n=5717\"\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 +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"Accreditation Information\" border=\"0\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/Web_Seminars\/AccreditationInformation.jpg?n=3445\"\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 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-15-078-L01-P. Released: 11\/15. \u003c\/p\u003e\n\u003cp class=\"Abstract\" align=\"center\"\u003e\u003cfont color=\"#0000ff\"\u003e\u003cstrong\u003eHold this course at your company! \u003c\/strong\u003e\u003cstrong\u003eFor more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/strong\u003e\u003c\/font\u003e \u003c\/p\u003e\n\u003cp class=\"Abstract\" align=\"left\"\u003e \u003c\/p\u003e\n\u003cp class=\"Abstract\" align=\"left\"\u003e \u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/randomized-controlled-trials-ethics-consenting-maintaining-the-blind-and-protocol-adherence.oembed","provider":"Barnett International ","version":"1.0","type":"link"}