{"product_id":"electronic-medical-records-approaches-for-ensuring-source-document-and-21-cfr-part-11-required-components-2027-01-20","title":"Electronic Medical Records: Approaches for Ensuring Source Document and 21 CFR Part 11 Required Components","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eCurrent societal events have influenced the increased use of an electronic medical record (EMR), one being the promotion of a national EMR. More and more research sites are using an EMR for all or part of their case histories for research subjects. The industry has defined the characteristics that source documents in any form must include, and 21 CFR Part 11 includes standards for electronic source data. Challenges in monitoring the original source document have been growing and unaddressed in many situations. The FDA's final guidance document for 21 CFR Part 11 supports certain characteristics that EMRs should include, but many site electronic records do not meet the requirements. This web seminar will discuss assessment of EMRs, ideal monitoring vs. contingency planning, and risk management.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDefine source documents (FDA and ICH GCP E6 Guideline)\u003c\/li\u003e \u003cli\u003eExplain required characteristics for source documents in any form\u003c\/li\u003e \u003cli\u003eDescribe requirements of electronic source documents (21 CFR Part 11)\u003c\/li\u003e \u003cli\u003eApply these concepts to electronic medical records at research sites\u003c\/li\u003e \u003cli\u003eApply contingency planning for electronic source document deficiencies\u003c\/li\u003e \u003cli\u003eManage site and sponsor activities regarding electronic medical records\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eInvestigators\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003eDevice and Drug Study Clinical Research Associates and Managers\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eDenise Redkar-Brown, MT\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 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 Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.5 hours (0.25 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#: 778-0000-23-056-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":53375364530541,"sku":"BI17630","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/electronic-medical-records-approaches-for-ensuring-source-document-and-21-cfr-part-11-required-components-2027-01-20","provider":"Barnett International ","version":"1.0","type":"link"}