20-Hour Fundamentals of Clinical Research Series: Getting Started in Clinical Research 2026

20-Hour Fundamentals of Clinical Research Series: Getting Started in Clinical Research is organized by Barnett International and will be held from Jan 06 - Feb 05, 2026.

Course Description:
The 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.

Prior 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.

Learning Objectives:

• Define clinical research and discuss how preclinical development leads to clinical development
• Explain the roles and responsibilities of all members of the clinical team: Sponsor, vendor, CRO, investigator, Institutional Review Board, subject and regulatory authority
• Describe the investigational product development process, including study design and the logic involved
• Define 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
• Define 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
• Describe the conduct of the study, including monitoring visits to the site and site performance management and communication
• Describe the management of adverse events and completion of study reporting and retention of documents
• Identify career opportunities and reference materials available

Course Outline

• Module 1: Clinical Research: Protection of the Human Research Subject and ICH GCP
• Module 2: The Clinical Research Team: Roles and Responsibilities of the FDA, Sponsor, CRO, Clinical Investigator, CRA, CRC, and IRB/IEC
• Module 3: Development of New Products: How are new drugs and medical devices developed?
• Module 4: The Protocol: Understanding the Contents and Purpose of the Protocol in Clinical Research
• Module 5: Selection of the Clinical Investigator: Process and Procedures, Informed Consent, and Monitoring Visits
• Module 6: Safety in Clinical Trials: Understanding Adverse Events and Reporting Requirements
• Module 7: Clinical Research: Recruitment of Subjects, Good Documentation Practices, Essential Documents, and Source Documentation
• Module 8: Submission to Regulatory Authorities: Process for Approval of New Drugs and New Medical Devices
• Module 9: FDA Inspections: Understanding Purpose and Procedures
• Module 10: Course Practicum and Overview of Career Pathways