{"product_id":"monitoring-clinical-drug-studies-beginner-2026-12-01","title":"Monitoring Clinical Drug Studies: Beginner","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis fundamental \"how to\" and \"why\" workshop focuses on current regulatory requirements to promote successful monitoring of studies. Participants will learn about the role and responsibilities of the monitor, the investigator, and the IRB from pre-study through post study. Best practice techniques for site management will be provided, and activities such as case scenarios and simulation exercises reviewing an informed consent document, investigator study file, subject case report forms, and source documents will reinforce learning concepts. This is a practical, hands-on introduction to the job and how clinical monitoring tasks are performed.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul style=\"list-style-type:disc;\"\u003e \u003cli\u003eDiscuss the role the CRA plays in the drug development process\u003c\/li\u003e \u003cli\u003eState the \"letter\" and \"spirit\" of FDA regulations as well as ethical considerations pertinent to conducting clinical trials\u003c\/li\u003e \u003cli\u003eIdentify and select qualified investigators and the investigative site\u003c\/li\u003e \u003cli\u003ePrepare for and conduct Site Selection\/Qualification, Site Initiation, Routine Monitoring, and Study Close-Out Visits\u003c\/li\u003e \u003cli\u003eManage and report adverse events (AEs)\u003c\/li\u003e \u003cli\u003eList study documentation requirements and standards for collecting and reporting clinical trial data\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul style=\"list-style-type:disc;\"\u003e\u003cli\u003eThis course is beneficial if you have been monitoring for less than one year, or if you are an in-house CRA or project assistant who supports CRA monitoring activities\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 style=\"list-style-type:disc;\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eOverview of Drug Development and ICH GCP:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eTerminology; the drug approval process\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eThe Clinical Research Team:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eRoles and responsibilities\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eThe Site Selection Process and Site Qualification Visits:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eLocating, screening, and evaluating prospective investigators; selection criteria\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Two\u003c\/p\u003e\u003cul style=\"list-style-type:disc;\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eIRBs\/IECs and the Protocol Approval Process:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eMembership requirements; documents and activities\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eStudy Subject Recruitment, and the Informed Consent Document and Process:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eFDA and ICH requirements; the role of the monitor in assuring appropriate consent \u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eInvestigator's Meetings and Study Initiation Visits:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003ePurpose, preparation, and documentation\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eManaging and Reporting Adverse Events:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eTerminology and examples; investigator and sponsor reporting requirements\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eInvestigational Product Accountability and Essential Documents:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eRegulatory and subject Documents; drug storage, documentation, and accountability requirements\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"bold-italic\"\u003eDay Three\u003c\/p\u003e\u003cul style=\"list-style-type:disc;\"\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eRoutine Monitoring Visits and Source Data Verification:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003ePreparing for, during the visit, and post visit activities; process for reviewing source documents and identifying discrepancies\u003c\/span\u003e\u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eClinical Data Management Overview, Trip Reports, and Study Close-out Visits:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003ePaperbased and electronic case report forms, queries, and conducting close-out visits\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eMonitoring Simulation Exercise:\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003eRegulatory Binder and Source Data Verification\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003e \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul style=\"list-style-type:disc;\"\u003e \u003cli\u003eBasic Monitoring Skills - Hands-on Simulation Exercise\u003c\/li\u003e \u003cli\u003eInformed Consent Critique and Selecting Clinical Sites\u003c\/li\u003e \u003cli\u003eIdentifying, Classifying, and Reporting Adverse Events\u003c\/li\u003e \u003cli\u003eDrug Accountability Case Studies and Calculating IP Compliance\u003c\/li\u003e \u003cli\u003eCase Scenarios: Site Selection, Study Initiation Visits, and Routine Monitoring Visits\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 22.5 hours (2.25 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#: 0778-0000-23-029-L99-P. Released: 3\/23. \u003c\/p\u003e\u003cp\u003e \u003cspan class=\"bold\"\u003e\u003c\/span\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\u003cp\u003e \u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375358861677,"sku":"SSBM1026","price":1995.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375358894445,"sku":"SSBM1026-ACADEMIC","price":1575.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/monitoring-clinical-drug-studies-beginner-2026-12-01","provider":"Barnett International ","version":"1.0","type":"link"}