{"product_id":"monitoring-visit-reports-for-medical-device-studies-2027-01-29","title":"Monitoring Visit Reports for Medical Device Studies","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eIn this web seminar, we will discuss how to write effective monitoring visit reports for medical device studies. Participants will learn the purpose for monitoring investigational sites and the importance of documenting the visit. We will examine the requirements for the documentation in the Code of Federal Regulations and ICH, and discuss how the report is used by various stakeholders. Tools will be provided to enable learners to scrutinize various sections of the report to better document what was accomplished on the visit. This documentation supports the adequate monitoring obligation expected by regulatory authorities.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the requirements of documenting monitoring activities for a device study\u003c\/li\u003e \u003cli\u003eRecognize the importance of a well written monitoring visit report, auditable by the regulatory authorities\u003c\/li\u003e \u003cli\u003eManage site and sponsor activities and document them appropriately\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\u003eContract Clinical Research Associates\u003c\/li\u003e \u003cli\u003eLead Clinical Research Associates\u003c\/li\u003e \u003cli\u003eClinical Research Managers\u003c\/li\u003e \u003cli\u003eAll other personnel responsible for writing or reviewing monitoring visit reports for device studies\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#: 0778-0000-23-064-L99-P. Released: 7\/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":53375363678573,"sku":"BI17651","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/monitoring-visit-reports-for-medical-device-studies-2027-01-29","provider":"Barnett International ","version":"1.0","type":"link"}