{"title":"Use of Electronic Health Record Data in Clinical Investigations","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\n\u003cp\u003eThe\nFDA recognizes Electronic Health Records (EHRs) as data originators and in many\ncases, source documentation, which therefore subjects them to inspection. In\nits draft guidance for the Use of Electronic Health Record Data in Clinical\nTrials, the FDA expands upon prior guidance and provides its recommendations on\nthe use of EHRs as source, and also outlines the responsibilities for ensuring\nquality and integrity of EHR data. As such, EHRs should be able to be obtained\nfrom multiple sources, they should be shareable, interoperable, and accessible\nto authorized parties. This web seminar will address recommendations for the\nuse of EHRs as source data in clinical trials.  \u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eDescribe the responsibilities and processes for\n     assessing the validity, reliability, and integrity of EHR source data\u003c\/li\u003e\n\u003cli\u003eReview the FDA’s intentions to\n     assess the compliance of EHRs with 21 CFR 11\u003c\/li\u003e\n\u003cli\u003eEvaluate best practices for using\n     EHRs in clinical research\u003c\/li\u003e\n\u003cli\u003eDescribe interoperability in EHR use\u003c\/li\u003e\n\u003cli\u003eDiscuss the impact on\n     recommendations for research conducted outside the U.S.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\n\u003cul type=\"disc\"\u003e\n\u003cli\u003eClinical Research Associates\u003c\/li\u003e\n\u003cli\u003eProject Managers\u003c\/li\u003e\n\u003cli\u003ePrincipal Investigators\u003c\/li\u003e\n\u003cli\u003eClinical Research Coordinators\u003c\/li\u003e\n\u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e\n\u003cli\u003eAcademic Medical Center and Research\n     Institution Professionals supporting clinical research\u003c\/li\u003e\n\u003cli\u003ePersonnel responsible for ensuring\n     compliance with GCP regulations\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\n\u003cp\u003eElizabeth\nRonk Nelson, M.P.H.\u003c\/p\u003e\n\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003e\u003cspan\u003eClick here for complete trainer\nbiographies\u003c\/span\u003e\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\n\u003cp\u003e$835\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eIncludes up to 20\nparticipants at one site. All participants (up to 20) are eligible for\n“Certificates of Attendance,” and accreditation, provided that accreditation\nrequirements are met. For groups larger than 20 or for additional sites, please\ncall +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eNote: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com \u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003eBarnett International is accredited by the\nAccreditation Council for Pharmacy Education as a provider of continuing\npharmacy education.  Participants will\nreceive 2 hours (0.2 CEUs) of continuing education credit for full\nparticipation, including the completion of a pre-test, post-test, and program\nevaluation.  Barnett International will\nissue a receipt of completion for earned CEUs within three weeks of program\ncompletion.  ACPE#: 0778-0000-20-054-L01-P.\nReleased: 3\/20.  \u003c\/span\u003e\u003c\/p\u003e\n\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003e\u003cspan\u003eHold\nthis course at your company! For more information, contact Naila Ganatra at +1\n215.413.2471.  \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/use-of-electronic-health-record-data-in-clinical-investigations.oembed","provider":"Barnett International ","version":"1.0","type":"link"}