Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new pr Read more
“An FDA inspector once said that any individual should be able to perform drug reconciliation at an investigative site within 20 minutes.” (2002 Applied Clinical Trials). Conducting a clinical trial with a drug or device that is not FDA approved or that is being used in an investigational manner can be daunting. A site must know the federal regulations, and have accountability practices. Learning about some best practices will make this task easier and more manageable.
This webinar will help clarify information to provide a foundation from which those responsible for investigational product accountability can build to avoid compliance issues and audit errors. We will discuss:
• The regulatory framework.
• Become familiar with investigational product best practices.
• Understand when a product is investigational.
• Know the research site’s responsibility.
• 21 CFR 312
• 21 CFR 812
• Good Clinical Practice guideline requirements study conduct
• Requirements under an Investigational New Drug Number
• Tracking methods to assist with investigational product accountability
• Areas that can create audit findings
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Human Subjects Research
• Healthcare interested in exploring the field of Clinical Research
• Clinical Research Coordinators, Associates, and Managers
• Administration in charge of Clinical Research, Clinical Research Sites
• Contract Research Organizations ,
• Regulatory Coordinators
• Principal Investigator positions, Sub-Investigators