Program Description

WHO SHOULD ATTEND: Clinical research professionals including investigators, research coordinators, research associates, project managers, consultants, educators, and administrators. Such participants may be affiliated with medical centers; cooperative research groups; research consortia; pharmaceutical, device, and biotechnology companies; contract research organizations; site management organizations; and independent research firms.

LEARNING OBJECTIVES: Upon completion of this course the attendee should be able to:

  • Discuss recent changes to the Common Rule (45 CFR 46)
  • Discuss FDA audit findings and best practices to avoid common pitfalls
  • Discuss strategies for quality assurance program development
  • Discuss how Trial Master File quality can improve site efficiency and effectiveness
  • Discuss the use and benefits of “centralized monitoring”
  • Discuss remote monitoring best practices
  • Discuss adverse event recognition and reporting
  • Discuss the regulatory and quality parameters of electronic data records
  • Describe the FDA guidelines for e-consent
  • Discuss how researchers can renew their emphasis on protections beyond the regulations
  • Discuss the role and importance of the project manager in clinical research
  • Discuss how to successfully implement and use risk based audit programs
  • Discuss how tools and strategies that can produce a proactive stance on the responsible conduct of research
  • Discuss best practices for using e-consent and passing IRB approval
  • Discuss techniques to overcome health disparities in research populations
  • Discuss best practices to avoid common errors in pediatric research
  • Discuss the regulatory requirements to start and conduct a sponsor-investigator IND trial
  • Discuss the process and challenges of expanded access programs
  • Discuss Health Canada’s Clinical Trial Compliance Program
  • Discuss proven and effective strategies for patient recruitment and retention
  • Discuss the benefits of self auditing programs
  • Discuss common issues in multi-national research
  • Discuss risk determination in device studies
  • Discuss best practices for developing market adoption evidence for device studies
  • Discuss clinical research budget development and negotiation
  • Discuss best practices for coding for clinical trials
  • Discuss best practice for clinical investigator site source documentation