{"product_id":"adverse-event-monitoring-for-cras-2027-01-27","title":"Adverse Event Monitoring for CRAs","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eDuring monitoring visits, one of the most important and impacting activities that a Clinical Research Associate (CRA) performs is the source document verification of Adverse Events (AEs). The CRA serves as the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of AEs can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post-marketing labeling. This includes causality, expectedness\/unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDefine safety concepts and reporting requirements\u003c\/li\u003e \u003cli\u003eRecognize the importance of verifying the subject baseline history\u003c\/li\u003e \u003cli\u003eDetermine when to start and stop monitoring AEs\u003c\/li\u003e \u003cli\u003eApply a detailed presentation of the source document verification process of AEs\u003c\/li\u003e \u003cli\u003eManage challenges in monitoring AEs\u003c\/li\u003e \u003cli\u003eDetermine appropriate credentialing for site AE evaluation of event relationship\u003c\/li\u003e \u003cli\u003eDescribe the impact of monitoring on future product labeling\u003c\/li\u003e \u003cli\u003eDiscuss reporting trends\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDevice and Drug Study Clinical Research Associates\u003c\/li\u003e \u003cli\u003eContract Clinical Research Associates\u003c\/li\u003e \u003cli\u003eClinical Research Associate Managers\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A.,T.I.A.C.R.\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$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#: 0778-0000-23-007-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":53375363940717,"sku":"BI17643","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/adverse-event-monitoring-for-cras-2027-01-27","provider":"Barnett International ","version":"1.0","type":"link"}