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Fundamentals of Clinical Research Monitoring

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Overview 

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

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

Contact Information 

Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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