{"product_id":"10-week-ich-gcp-e6-risk-based-monitoring-plan-development-series-2026-12-10","title":"10-Week ICH GCP E6: Risk-Based Monitoring Plan Development Series","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eRisk-based approaches to clinical trials and risk-based monitoring are now required for clinical trial sponsors under ICH GCP E6(R3) Addendum. This comprehensive 10-week series provides a step-by-step approach for developing the content of the clinical trial monitoring plan. Specific attention is given to translating the Trial Risk Assessment (TRA) output and Integrated Quality Risk Management Plan (IQRMP) into a well-orchestrated document that is concise, comprehensive, and clearly articulates the complete strategy for all aspects of the monitoring to be undertaken and how risks will be mitigated.\u003c\/p\u003e\u003cp\u003ePrior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe the monitoring responsibilities of a risk-based quality management trial and the key areas to focus on and include in the monitoring plan\u003c\/li\u003e \u003cli\u003eExplain how the TRA and IQRMP outputs are integrated into the monitoring plan\u003c\/li\u003e \u003cli\u003eExplain the importance of proactive risk-based monitoring that allows for real-time identification and management of potential risks\u003c\/li\u003e \u003cli\u003eIdentify the stakeholders necessary for monitoring plan development\u003c\/li\u003e \u003cli\u003eExplain inclusion of roles, responsibilities, and communication strategies in the monitoring plan\u003c\/li\u003e \u003cli\u003eIdentify content and the components needed for developing a clear and concise risk-based monitoring plan\u003c\/li\u003e \u003cli\u003eDiscuss how critical and non-critical data are to be incorporated into the monitoring framework, while remaining focused on critical processes and data, and ensuring monitoring efforts are proportionate to the identified risks\u003c\/li\u003e \u003cli\u003eDefine centralized monitoring activities based on a case study and how to include these activities in the monitoring plan\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eModule 1: Monitoring Plan Overview, Stakeholders, and Planning for Success\u003c\/li\u003e \u003cli\u003eModule 2: Deriving Input: Risks, Critical Data\/Processes, Mitigation Plans\u003c\/li\u003e \u003cli\u003eModule 3: Case Study: Let's Get Started\u003c\/li\u003e \u003cli\u003eModule 4: On-Site Visit and Site Management\u003c\/li\u003e \u003cli\u003eModule 5: Off-Site (Remote) Site Monitorin\u003c\/li\u003e \u003cli\u003eModule 6: Centralized\/Statistical Monitoring\u003c\/li\u003e \u003cli\u003eModule 7: Escalation and De-escalation\/Management of Noncompliance\u003c\/li\u003e \u003cli\u003eModule 8: End of Study Activities and Other Monitoring Plan Components\u003c\/li\u003e \u003cli\u003eModule 9: Drivers for Revisions and Updates\u003c\/li\u003e \u003cli\u003eModule 10: Regulatory Agency Inspections: Helpful Tips\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Trial Managers\/Study Leads\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eClinical Trial Management\/Clinical Operations Directors\u003c\/li\u003e \u003cli\u003eQuality Compliance Professionals\u003c\/li\u003e \u003cli\u003eData Managers and Statisticians\u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003eNOTE: This course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp class=\"abstract\"\u003e\u003cspan class=\"bold\"\u003eWhat previous students have said ...\u003c\/span\u003e \u003c\/p\u003e\u003cp\u003e\"I now have more tools and guidance when writing my next monitoring plan for upcoming trials to account for expectations from E6 R2 changes.\"\u003c\/p\u003e\u003cp\u003e\"This series clarified a lot of the questions I had regarding risk-based monitoring and also confirmed that we are on our way to having a great risk-based monitoring plan. The risk assessment lessons were key for me.\"\u003c\/p\u003e\u003cp\u003e\"Very helpful guidance to monitoring and data management.\"\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003e\u003cb\u003e\u003ci\u003eThe course will be led by one of the following instructors:\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003eTreena Jackson, M.S., M.A., C.Q.A., R.A.C., C.S.S.G.B.\u003c\/p\u003e\u003cp\u003eHeather Marshall, M.S.N., B.S.N., R.N.\u003c\/p\u003e\u003cp\u003eShana Zink, B.S., C.C.R.A.\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\"\u003e\u003cspan class=\"purple-link\"\u003e\u003cb\u003e\u003ci\u003eCourse Length and Time\u003c\/i\u003e \u003c\/b\u003e \u003c\/span\u003e \u003c\/p\u003e\u003cp\u003e10 weeks for 2 hours each week.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$1,695 by Early Bird Deadline \u003c\/p\u003e\u003cp\u003e$1,895 after Early Bird Deadline\u003c\/p\u003e\u003cp\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp\u003eAll participants are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met.\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 20 hours (2.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-040-L99-P. Released: 10\/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":53375366529389,"sku":"BI17582","price":1895.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375366562157,"sku":"BI17582-ACADEMIC","price":1695.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/10-week-ich-gcp-e6-risk-based-monitoring-plan-development-series-2026-12-10","provider":"Barnett International ","version":"1.0","type":"link"}