{"product_id":"introduction-to-clinical-research-2026-11-04","title":"Introduction to Clinical Research","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis two-day course will cover topics designed to explain exactly what a clinical trial is and how clinical research is conducted. Since many clinical trials are often conducted in the European Union (EU), we will also include some key EU requirements. We will start by looking at the history of clinical trials to give you a better understanding of how and why current regulations were created to protect and inform clinical trial participants as well as ensure the public that the information obtained from those trials is accurate and reliable. Then we will look at the process of drug and device development from discovery to approval. We will introduce you to the protocol which is the blueprint for any clinical trial and explain what an informed consent is and why it is so important. In addition to these key trial documents, we will also review other important documents that are used in clinical trials. Finally, we will provide you with resources that will enable you to stay informed about topics and regulations regarding clinical trials in the U.S. and in the European Union.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eIdentify the members of the clinical research team and describe their primary roles and responsibilities\u003c\/li\u003e \u003cli\u003eDescribe the difference between drug development and medical device development\u003c\/li\u003e \u003cli\u003eDiscuss the historical events and importance of Good Clinical Practice (GCP) in clinical research conducted throughout the world\u003c\/li\u003e \u003cli\u003eIdentify key FDA and EU regulations that pertain to clinical research\u003c\/li\u003e \u003cli\u003eDescribe what a clinical protocol, informed consent, investigator's brochure, and essential documents are and their importance in clinical trials\u003c\/li\u003e \u003cli\u003eIdentify how safety information is collected and reviewed during clinical trials\u003c\/li\u003e \u003cli\u003eDefine and identify adverse events\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Research Associates and Clinical Research Coordinators with less than six months experience\u003c\/li\u003e \u003cli\u003eNurses\u003c\/li\u003e \u003cli\u003eIndividuals interested in the fundamentals of clinical research and clinical trials\u003c\/li\u003e \u003cli\u003eAspiring Clinical Research Associates and Clinical Research Coordinators\u003c\/li\u003e \u003cli\u003eCollege Students and New Graduates considering a career in clinical research\u003c\/li\u003e \u003cli\u003eIndividuals considering participating in a clinical trial or know of someone who is considering participating in a clinical trial\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\"\u003eThe Evolution of Research Ethics\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eGood Clinical Practice\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eInvestigational Product Development\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eClinical Research Team\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\"\u003eElements of a Good Clinical Study\u003c\/span\u003e \u003cspan class=\"normal-text\"\u003e\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eInformed Consent and Confidentiality\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eClinical Trials and Safety Information\u003c\/span\u003e \u003c\/li\u003e \u003cli\u003e \u003cspan class=\"bold\"\u003eAudits and Inspections\u003c\/span\u003e \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInteractive Activities\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDiscussion: Ethics in Clinical Research\u003c\/li\u003e \u003cli\u003eProtocol and Informed Consent Review\u003c\/li\u003e \u003cli\u003eRecruitment Advertisement Review\u003c\/li\u003e \u003cli\u003eIdentifying and Delineating Clinical Research Team Roles and Responsibilities\u003c\/li\u003e \u003cli\u003eAdverse Event Identification Exercise\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#: 0778-0000-24-004-L99-P. Released: 3\/24. \u003c\/p\u003e\u003cp\u003e \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\u003cb\u003e\u003c\/b\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375369478509,"sku":"BI17510","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/introduction-to-clinical-research-2026-11-04","provider":"Barnett International ","version":"1.0","type":"link"}