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Fundamentals of Clinical Research Monitoring


Interactive lecture and hands-on workshop training methods provide participants with the tools to design and manage clinical studies.
Course Level: Beginner

What you will learn

  • Good clinical practices (GCP)
  • Regulatory requirements for clinical research
  • Clinical research methodology and its role in pharmaceutical development
  • The role of clinical research associates (CRA) in clinical research
  • Monitoring clinical trials to ensure valid and useful study data
  • Investigator selection and evaluation
  • US Food and Drug Administration (FDA) audits
  • Basic Health Insurance Portability and Accountability Act (HIPAA) requirements
  • Basic protocol development

Who should attend?

  • Clinical research associates and clinical study monitors with less than two years of experience
  • Administrative support personnel
  • Study support personnel

Learning objectives

Participants who complete this training should be able to:

  • Describe the basic clinical research elements in drug development
  • Recognize the basic elements of clinical trial methodology in the conduct of clinical studies
  • Identify roles and responsibilities, and regulatory requirements pertinent to clinical research associates
  • Apply “hands-on” clinical trial monitoring experience to the conduct of clinical studies
  • Identify and select qualified clinical investigators
  • Recognize the requirements for safety surveillance
  • Apply the principles of auditing in clinical investigations
  • Recognize the elements of protocol development