{"product_id":"20-hour-fundamentals-of-clinical-research-series-getting-started-in-clinical-research-2027-01-12","title":"20-Hour Fundamentals of Clinical Research Series: Getting Started in Clinical Research","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe 20-Hour Fundamentals of Clinical Research Series provides a comprehensive introduction to clinical research for newly hired clinical research professionals or individuals interested in working in the pharmaceutical and medical device industry. Participants will learn about the basics of clinical research. The series covers core sponsor and investigator site activities to help learners understand the key considerations in the real-life work of clinical researchers. This course covers FDA regulations, the importance of ICH GCP, protocol development, monitoring in clinical research, and the identification and reporting of adverse events. Activities in the course include interactive discussions, knowledge checks, and a final course practicum exercise. \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\u003eDefine clinical research and discuss how preclinical development leads to clinical development \u003c\/li\u003e \u003cli\u003eExplain the roles and responsibilities of all members of the clinical team: Sponsor, vendor, CRO, investigator, Institutional Review Board, subject and regulatory authority \u003c\/li\u003e \u003cli\u003eDescribe the investigational product development process, including study design and the logic involved \u003c\/li\u003e \u003cli\u003eDefine the regulatory requirements, including principles of Good Clinical Practice from the International Council for Harmonization, FDA regulations (Code of Federal Regulations), ethical considerations for a study and the need for Standard Operating Procedures \u003c\/li\u003e \u003cli\u003eDefine the steps involved in proceeding with the study: Sponsor development of protocol, case report form, informed consent document, budget, database and identifying an investigational site \u003c\/li\u003e \u003cli\u003eDescribe the conduct of the study, including monitoring visits to the site and site performance management and communication \u003c\/li\u003e \u003cli\u003eDescribe the management of adverse events and completion of study reporting and retention of documents \u003c\/li\u003e \u003cli\u003eIdentify career opportunities and reference materials available \u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eModule 1: Clinical Research: Protection of the Human Research Subject and ICH GCP\u003c\/li\u003e \u003cli\u003eModule 2: The Clinical Research Team: Roles and Responsibilities of the FDA, Sponsor, CRO, Clinical Investigator, CRA, CRC, and IRB\/IEC \u003c\/li\u003e \u003cli\u003eModule 3: Development of New Products: How are new drugs and medical devices developed?\u003c\/li\u003e \u003cli\u003eModule 4: The Protocol: Understanding the Contents and Purpose of the Protocol in Clinical Research \u003c\/li\u003e \u003cli\u003eModule 5: Selection of the Clinical Investigator: Process and Procedures, Informed Consent, and Monitoring Visits \u003c\/li\u003e \u003cli\u003eModule 6: Safety in Clinical Trials: Understanding Adverse Events and Reporting Requirements \u003c\/li\u003e \u003cli\u003eModule 7: Clinical Research: Recruitment of Subjects, Good Documentation Practices, Essential Documents, and Source Documentation \u003c\/li\u003e \u003cli\u003eModule 8: Submission to Regulatory Authorities: Process for Approval of New Drugs and New Medical Devices\u003c\/li\u003e \u003cli\u003eModule 9: FDA Inspections: Understanding Purpose and Procedures \u003c\/li\u003e \u003cli\u003eModule 10: Course Practicum and Overview of Career Pathways\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eThose who are new to clinical research\u003c\/li\u003e \u003cli\u003eAspiring Clinical Research Coordinators and Clinical Research Associates\u003c\/li\u003e \u003cli\u003eNurses interested in clinical research \u003c\/li\u003e \u003cli\u003eAspiring and Entry Level Project Managers (looking to gain experience in clinical research)\u003c\/li\u003e \u003cli\u003eCollege Students and New Graduates in a Scientific Field\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\"The course was great and I learned a great deal. The course was perfectly suited to my requirements and gave me the insight that I wished for. Thank you.\"\u003c\/p\u003e\u003cp\u003e\"I've been working as a CTA for 9 months now, it was good to get a solid overview of the clinical research process. I learned more about FDA \u0026amp; ICH which will be helpful.\"\u003c\/p\u003e\u003cp\u003e\"I now have a much clearer overview of the various roles and responsibilities as well as the overall clinical research process.\"\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInstructors\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\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\u003eElizabeth Weeks-Rowe, LVN, C.C.R.A.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-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\u003eTwo 2-Hour classes each week for 5 weeks\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#: 0778-0000-24-009-L99-P. Released: 1\/24.\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":53375364858221,"sku":"BI17621","price":1895.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375364890989,"sku":"BI17621-ACADEMIC","price":1695.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/20-hour-fundamentals-of-clinical-research-series-getting-started-in-clinical-research-2027-01-12","provider":"Barnett International ","version":"1.0","type":"link"}