• 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

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

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