{"product_id":"risk-based-monitoring-the-data-management-connection-2026-08-26","title":"Risk-Based Monitoring: the Data Management Connection","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe final guidance, \"Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring\" was released in August 2013. In addition to the FDA Guidance, there is significant reference to Risk Management in the latest ICH E6(R3), finalized January 2025. The purpose of Good Clinical Practice as described in E6(R3), \"Clinical trial processes and risk mitigation strategies implemented to support the conduct of the trial should be proportionate to the importance of the data being collected and the risks to trial participant.\" \"Effective implementation of risk-based monitoring, including the prioritization of monitoring and other oversight activities directed at processes and procedures critical for human subject protection and maintaining data integrity, should help maximize the quality of a clinical investigation.\"\u003c\/p\u003e\u003cp\u003eWe will examine both the FDA Guidance and ICH E6(R3) regarding expectations and directives to ensure that Risk Management is an integral process in the conduct of clinical trials and the role that CDM can play in ensuring that risk is minimized when it applies to data quality.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eRecognize the rationale regarding risk-based monitoring\u003c\/li\u003e \u003cli\u003eIllustrate the active role that CDM is expected to exhibit in this approach\u003c\/li\u003e \u003cli\u003eList the potential CDM reports to assist in identification of data aberrations\u003c\/li\u003e \u003cli\u003eInterpret the way forward for future CDM activities\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Data Managers\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eClinical Trial 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 G. 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$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#: 0778-0000-25-046-L99-P. Released: 8\/25. \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":53375388811629,"sku":"BI17382","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/risk-based-monitoring-the-data-management-connection-2026-08-26","provider":"Barnett International ","version":"1.0","type":"link"}