{"product_id":"30-hour-clinical-research-auditing-certification-program-2026-10-20","title":"30-Hour Clinical Research Auditing Certification Program","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe online 10-Week Clinical Research Auditing Certification Program provides a comprehensive introduction to clinical research and the job function of the Clinical Quality Assurance Auditor for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or transitioning into Good Clinical Practice (GCP) auditing. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the GCP auditor.\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\u003eDescribe and discuss the investigational product development process, including FDA regulations, ICH guidelines, and Good Clinical Practices (GCPs)\u003c\/li\u003e \u003cli\u003eExplain the roles and responsibilities of a Clinical Quality Assurance Auditor\u003c\/li\u003e \u003cli\u003eDescribe the types of audits, including the responsibilities of the auditor in preparation, activities, and follow-up\u003c\/li\u003e \u003cli\u003eExamine and apply the FDA's methods for inspections of Clinical Investigators, IRBs, sponsors\/CROs\u003c\/li\u003e \u003cli\u003eDiscuss regulatory compliance and quality assurance issues and documentation\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eModule 1: Investigational Product Development, the FDA, and Good Clinical Practice Guidelines\u003c\/li\u003e \u003cli\u003eModule 2: Auditing as a Profession and Compliance Tool\u003c\/li\u003e \u003cli\u003eModule 3: The Types of Clinical Research Audits and Preparation\u003c\/li\u003e \u003cli\u003eModule 4: Quality Systems for Auditing\u003c\/li\u003e \u003cli\u003eModule 5: Risk-Based Auditing and Developing Risk-Based Auditing Plans\u003c\/li\u003e \u003cli\u003eModule 6: The Auditing Process: Clinical Investigator\u003c\/li\u003e \u003cli\u003eModule 7: The Auditing Process: Institutional Review Board\/Ethics Committee\u003c\/li\u003e \u003cli\u003eModule 8: The Auditing Process: Sponsor\/CRO\u003c\/li\u003e \u003cli\u003eModule 9: Gathering and Disseminating Information: Verbal and Written Communication\u003c\/li\u003e \u003cli\u003eModule 10: Regulatory Classification and Communication: Recent Inspection Findings\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Quality and Compliance Professionals\u003c\/li\u003e \u003cli\u003eNew or Aspiring Auditors\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eMedical Monitors\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eClinical Research Coordinators\u003c\/li\u003e \u003cli\u003eClinical Principal Investigators\u003c\/li\u003e \u003cli\u003eIRB Administrators and Members\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 participants say about Barnett's 10-Week courses ...\u003c\/span\u003e\u003c\/p\u003e\u003cp\u003e\"Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.\"\u003c\/p\u003e\u003cp\u003e\"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!\"\u003c\/p\u003e\u003cp\u003e\"This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!\"\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eElizabeth Ronk Nelson, M.P.H.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.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\"\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\u003e10 weeks for 3 hours each week.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$1,795 by Early Bird Deadline \u003c\/p\u003e\u003cp\u003e$1,995 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 30 hours (3.0 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#: 0778-0000-23-046-L99-P. Released: 7\/23. \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":53375369576813,"sku":"BI17507","price":1995.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375369609581,"sku":"BI17507-ACADEMIC","price":1795.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/30-hour-clinical-research-auditing-certification-program-2026-10-20","provider":"Barnett International ","version":"1.0","type":"link"}