{"product_id":"monitoring-clinical-drug-studies-advanced-2026-10-28","title":"Monitoring Clinical Drug Studies: Advanced","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis course will focus on more complex and challenging issues affecting the Clinical Research Associate with management\/leadership responsibilities. Current hot topics and trends will be discussed. Participants will analyze case studies to identify how monitors\/study leaders could have identified, managed, and followed up on under performance or non-compliance issues. Corrective and preventive action plans (CAPA) will be developed as part of the course activities. Training and mentoring techniques will be included to assist training\/mentoring sponsor\/CRO and site staff.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eExplain the most recent regulations and guidance documents that govern clinical research\u003c\/li\u003e \u003cli\u003eDiscuss current issues that affect clinical monitoring\u003c\/li\u003e \u003cli\u003eDescribe effective mentoring techniques\u003c\/li\u003e \u003cli\u003eDiscuss ways of assessing monitor skills\u003c\/li\u003e \u003cli\u003eDevelop techniques to manage stakeholders\u003c\/li\u003e \u003cli\u003eDefine techniques to promote successful site management\u003c\/li\u003e \u003cli\u003eIdentify, manage, and report study-related issues\u003c\/li\u003e \u003cli\u003eDescribe how to manage situations involving fraudulent data\u003c\/li\u003e \u003cli\u003eDiscuss FDA's BIMO program for sponsor and investigator inspections\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e\u003cli\u003eCRAs with management responsibilities that include mentoring and assessing monitoring skills and complex issues involving site management, study management, sponsor\/ CRO challenges\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\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 Update:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eThe latest FDA Guidances will be reviewed\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eMonitoring Visits Update:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eRisk-Based Monitoring Approach\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eMonitoring Plans:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eWriting, evaluating, implementing, and assessing effectiveness\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eMentoring, Communication, and Negotiating Skills:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eTips for making the most of \"mentoring\" opportunities\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eCo-Monitoring\/Assessing Monitoring Skills:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eTechniques for assessing monitors in the Sponsor\/CRO environment\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Two \u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eManaging Stakeholders:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDeveloping and communicating realistic expectations; reaching stakeholder agreement\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eSite Management (Performance)\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e\u003cspan class=\"bold\"\u003eIdentifying, Reporting and Managing Study-Specific Issues\/Corrective and Preventive Action Plans\u003c\/span\u003e\u003c\/li\u003e \u003cli\u003e\u003cspan class=\"bold\"\u003eManaging Situations Involving Fraudulent Data\u003c\/span\u003e\u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eRegulatory Compliance:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eDiscussion of sponsor and investigational site inspections by FDA; current information regarding FDA and regulatory authority inspections\/audits; practical tips for preparing your site for an audit\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eReviewing Reports and Study Documentation\u003c\/li\u003e \u003cli\u003eCase Studies\/Scenarios: Assessing Monitoring Skills, Site Issues, Stakeholder Relations\u003c\/li\u003e \u003cli\u003eDetecting Fraudulent Data\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#: 0778-0000-24-006-L99-P. Released: 3\/24. \u003c\/p\u003e\u003cp\u003e \u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375359091053,"sku":"SSAJ1026","price":1895.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375359123821,"sku":"SSAJ1026-ACADEMIC","price":1475.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/monitoring-clinical-drug-studies-advanced-2026-10-28","provider":"Barnett International ","version":"1.0","type":"link"}