{"product_id":"monitoring-medical-device-trials-an-introduction-2026-08-06","title":"Monitoring Medical Device Trials: An Introduction","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis web seminar will provide the core concepts involved in monitoring medical device studies, including activities conducted at the investigator site, communication between monitor visits, and monitoring with centralized systems. We will explore the monitoring concepts as provided by the FDA in the Risk-Based Monitoring Guidance, as well as the ICH as interpreted for medical device trials. The basics of clinical monitoring and appropriate documentation to support adequate oversight of the study will be covered. Sponsor responsibilities and the role of the Clinical Research Associate\/ Monitor will be explored. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the regulatory purpose of monitoring device studies\u003c\/li\u003e \u003cli\u003eDefine the basic types of monitoring visits and documentation requirements\u003c\/li\u003e \u003cli\u003eExplore the roles and responsibilities of the Clinical Research Associate (Monitor) for the various types of visits\u003c\/li\u003e \u003cli\u003eDiscuss the meaning of protocol and regulatory (GCP) compliance\u003c\/li\u003e \u003cli\u003eRecognize the rationale behind adequate documentation of monitoring including identification of issues, corrective and preventive action and evaluation of effectiveness for issues (both site and sponsor)\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003ePersonnel responsible for monitoring or managing medical device trials\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructors\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e \u003c\/p\u003e\u003cp\u003eHeather Marshall, M.S.N., B.S.N., R.N.\u003c\/p\u003e\u003cp\u003eShana Zink, B.S., C.C.R.A.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e \u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\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 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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-23-017-L99-P. Released: 1\/23. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375390712173,"sku":"BI17353","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/monitoring-medical-device-trials-an-introduction-2026-08-06","provider":"Barnett International ","version":"1.0","type":"link"}