{"product_id":"monitoring-clinical-drug-studies-intermediate-2026-12-17","title":"Monitoring Clinical Drug Studies: Intermediate","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis course reflects current industry trends and challenges for the more experienced monitor\/clinical research associate - with a focus on developing tools and identifying challenges for effective monitoring. Industry standards and best practices will be discussed with an emphasis on the relationship between the Sponsor\/CRO and the Investigator\/site personnel. References and resources (including those available online) will be provided. Topics include site management, developing tools for effective monitoring, co-monitoring assessments, monitoring plan development best practices, and successful time management. Discussion will include how sponsors\/CROs interpret and implement various aspects of clinical trials and GCP principles.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDescribe various sponsor interpretations of FDA regulations and practical application of the ICH GCP E6 Guideline\u003c\/li\u003e \u003cli\u003eDiscuss current trends in clinical research\u003c\/li\u003e \u003cli\u003eEvaluate and develop more efficient study tracking and management tools\u003c\/li\u003e \u003cli\u003eIdentify more effective mentoring and CRA assessments\u003c\/li\u003e \u003cli\u003eManage your sites more effectively and ensure their optimum performance\u003c\/li\u003e \u003cli\u003eIdentify strategies for managing issues including root cause analysis and corrective and preventive action plans (CAPA)\u003c\/li\u003e \u003cli\u003eDevelop effective monitoring plans and best practices\u003c\/li\u003e \u003cli\u003ePrepare sites for an FDA\/Regulatory Authority inspection\u003c\/li\u003e \u003cli\u003eDescribe how FDA\/Regulatory Authority assess sponsor monitoring during inspections\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eExperienced Clinical Research Associates and Medical Research Associates with more than two years of experience seeking to update their knowledge of the GCP regulations and guidelines and fine tune their site management and monitoring skills\u003c\/li\u003e \u003cli\u003eClinical Research Professionals involved in the management of Clinical Research Associates, and\/or study\/project management\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eThe course will be led by one of the following instructors:\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A.,T.I.A.C.R.\u003c\/p\u003e\u003cp\u003eSonja Cooper, Ph.D., M.B.A.\u003c\/p\u003e\u003cp\u003eJanet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.\u003c\/p\u003e\u003cp\u003eLily Romero, P.A., C.C.R.C.\u003c\/p\u003e\u003cp\u003eElizabeth Weeks-Rowe, LVN, C.C.R.A.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.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\"\u003eCourse Outline\u003c\/p\u003e\u003cp class=\"bold-italic\"\u003eDay One\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eRegulatory Recap and Update:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eApplication of GCP: FDA regulations, guidance documents and the ICH GCP E6 Guideline\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eMonitoring and CRA Assessment, Monitoring Tools and Tracking Systems:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eBest Practices\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eSuccessful Site Management:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eInfluencing without authority, analyzing site performance problems; exploring root causes; corrective and preventive action plans (CAPA)\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Two\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e\u003cb\u003eMonitoring Plan Development and Best Practices\u003c\/b\u003e\u003c\/li\u003e \u003cli\u003e\u003cspan class=\"bold\"\u003eProblem Solving and Prioritizing Monitoring Challenges: Monitoring simulation\u003c\/span\u003e\u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eFDA Inspections and Site Preparation:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eMechanics of an FDA inspection; FDA classifications; common deficiencies; possible restrictions; tips for helping sites prepare for an FDA inspection\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eThe experienced Monitor's simulation exercise\u003c\/li\u003e \u003cli\u003eCase studies in motivation and site management\u003c\/li\u003e \u003cli\u003eCAPA documentation critique\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e \u003c\/p\u003e\u003cdiv\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/div\u003e\u003cdiv\u003e\u003cbr\u003e\u003c\/div\u003e\u003cdiv\u003e \u003cp\u003eSpecial rates are available for multiple attendees from the same organization. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for more information. Or email Customer Service at: customer.service@barnettinternational.com.\u003c\/p\u003e \u003cp\u003e\u003ca href=\"\/pages\/faqs\" title=\"Click here for our seminar cancellation policy\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003cbr\u003e\u003c\/p\u003e \u003c\/div\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 15 hours (1.5 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#: 0778-0000-24-005-L99-P. Released: 3\/24. \u003c\/p\u003e\u003cp\u003e\u003cfont color=\"inherit\" face=\"inherit\" size=\"-1\"\u003e Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/font\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cb\u003e \u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375358730605,"sku":"SSIM1226","price":1895.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375358763373,"sku":"SSIM1226-ACADEMIC","price":1475.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/monitoring-clinical-drug-studies-intermediate-2026-12-17","provider":"Barnett International ","version":"1.0","type":"link"}