{"product_id":"risk-based-thinking-how-monitors-can-develop-an-auditor-s-perspective-2026-12-04","title":"\"Risk-Based Thinking\": How Monitors Can Develop an Auditor's Perspective","description":"\u003cp\u003e \u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e \u003cp\u003eThe regulations require that sponsors ensure the selection of qualified monitors and the proper monitoring of clinical investigations. However, sponsors are frequently cited by the FDA for failure to meet those requirements. These regulatory communications note that although monitors might have identified issues, they did not appreciate the significance of those findings. As a result, opportunities to promptly secure compliance might be missed.\u003c\/p\u003e \u003cp\u003eClinical research is structured to incorporate monitoring processes more frequently than auditing. Yet as monitoring integrates a risk-based approach, monitors can utilize many auditing techniques to assist them in more effectively performing their tasks and meeting their obligations. This web seminar will explore the processes for critically reviewing findings to discern the implications and impact on subject safety and data integrity.\u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eVideo Preview\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e \u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eUtilize auditing techniques when performing monitoring tasks\u003c\/li\u003e \u003cli\u003eDefine EEproper monitoringEE and who is responsible for its conduct\u003c\/li\u003e \u003cli\u003eDiscuss monitoring findings within the context of regulatory risk\u003c\/li\u003e \u003cli\u003eReview standard monitoring report templates and discuss ways to adapt them to develop a compliance assessment\u003c\/li\u003e \u003cli\u003eDescribe processes for discerning patterns in information reviewed\u003c\/li\u003e \u003cli\u003eExplore methods for developing monitoring tools that facilitate a systems review and communication\u003c\/li\u003e \u003c\/ul\u003e \u003cp class=\"er-block-grey\"\u003eWho Should Attend\u003c\/p\u003e \u003cul type=\"disc\"\u003e \u003cli\u003eClinical 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\u003eElizabeth Ronk Nelson, M.P.H.\u003c\/p\u003e \u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003cspan\u003e\u003ca href=\"\/pages\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e \u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003e\u003cspan\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/span\u003e\u003cb\u003e\u003cspan\u003e\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eaali\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375367053677,"sku":"BI17568","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/risk-based-thinking-how-monitors-can-develop-an-auditor-s-perspective-2026-12-04","provider":"Barnett International ","version":"1.0","type":"link"}