{"product_id":"strategies-for-assessing-risk-tolerance-2026-11-23","title":"Strategies for Assessing Risk Tolerance","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThere are big expectations when it comes to risk in clinical trials. ICH E6(R3) underscores the importance of adopting a risk-based approach and is a tool health authorities expect clinical research professionals to utilize. But are all risks the same? How do you know what risks can be tolerated vs. those requiring significant time and resources? \u003c\/p\u003e\u003cp\u003eThis web seminar will help learners gain a better understanding of risk and how to determine risk tolerance levels (acceptable ranges). ICH E6(R3) has modified the risk management framework of Quality Tolerance Limits to acceptable ranges which allows for more flexibility while maintaining the scientific rigor or the clinical trial. The pre-specified ranges will still take into account the participant safety and reliability of the trial results. In this training we will discuss setting these ranges and what to do when a deviation to a range occurs, along with documentation. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDefine risk\u003c\/li\u003e \u003cli\u003eState a commonly held myth about risk and explain why it is a myth\u003c\/li\u003e \u003cli\u003eDescribe risk tolerance\u003c\/li\u003e \u003cli\u003eDescribe the methodology for determining risk tolerance\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Operations Personnel\u003c\/li\u003e \u003cli\u003eData Management Professionals\u003c\/li\u003e \u003cli\u003eQuality and Regulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eStudy Managers\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eSusan M. Leister, M.B.A., Ph.D., CQA, CSSBB\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#: 0778-0000-24-063-L99-P. Released: 9\/24. \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":53375368036717,"sku":"BI17548","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/strategies-for-assessing-risk-tolerance-2026-11-23","provider":"Barnett International ","version":"1.0","type":"link"}