{"title":"Writing the Clinical Study Protocol","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis short course provides insights into writing a clinical study protocol,\na key component for the success of any drug, device or food\/dietary\nsupplement development program. A well-designed protocol is essential\nfor IRB and regulatory approval, as poorly designed protocols can lead to\ntrial failure. Understanding the different approaches required for phase 0-4\npharmaceutical trials and pilot or pivotal medical device trials, as well as\nmanaging amendments, is critical to avoiding clinical holds and ensuring\nsuccess.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eDescribe protocol structure, regulatory requirements and study variations across drug\/ device development stages\u003c\/li\u003e\n\u003cli\u003eDescribe the requirements for a protocol\u003c\/li\u003e\n\u003cli\u003eDesign scientifically rigorous studies, establish safety and efficacy and develop hypothesis and endpoints\u003c\/li\u003e\n\u003cli\u003eDetermine inclusion\/exclusion criteria, develop the Schedule of Events and specify adverse and serious adverse event reporting\u003c\/li\u003e\n\u003cli\u003eWork with cross-functional teams, use development tools and know when to amend a protocol\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\n\u003cli\u003eMedical Directors\/Writers\u003c\/li\u003e\n\u003cli\u003eClinical Research Associates\u003c\/li\u003e\n\u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e\n\u003cli\u003eResearch and Development Personnel\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eJoy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.C.P.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer\n            biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the\n    Accreditation Council for Pharmacy Education as a provider of continuing\n    pharmacy education.  Participants will\n    receive 3 hours (0.3 CEUs) of continuing education credit for full\n    participation, including the completion of a pre-test, post-test, and program\n    evaluation.  Barnett International will\n    issue a receipt of completion for earned CEUs within three weeks of program\n    completion.  ACPE#: 0778-0000-23-026-L99-P.\n    Released: 3\/23. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold\n this course at your company! For more information, contact Naila Ganatra at +1\n        215.413.2471.\u003c\/span\u003e\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/writing-the-clinical-study-protocol.oembed","provider":"Barnett International ","version":"1.0","type":"link"}