Protocol Deviations: Documenting, Managing, and Reporting
Duration : 60 Minutes
Sarah Fowler-Dixon, Clinical Research
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
Clinical investigators are required to conduct a clinical trial according to the research protocol. Most research protocols are written for an ideal world but the studies are carried out in the real world. This creates deviations, whether planned or unplanned. It is important to know what current expectations are regarding reporting to regulatory authorities to avoid non-compliance issues which can create delays in the conduct of research.
Why Should Attend:
Deviations have often been misunderstood, misclassified, and misreported. This webinar will help answer questions about deviations such as: What is a deviation? What’s the best way to manage deviations? Can they be avoided? What is their importance? Do deviations impact subject safety or data integrity? How can the research team anticipate, manage, and minimize the impact of protocol deviations?
Course Objective:
• Define protocol deviations
• Review the requirements for reporting such events to regulatory authorities
• Review ICH guidelines and Good Clinical Practice (GCP)
• Discuss Department of Health and Human Services (DHHS) guidance
• Delve into Food and Drug Administration guidance
Course Outline:
• FDA Determination Letters regarding deviations
• Definition of a deviation
• What ICH, DHHS and FDA say about deviations
• Types of deviations
• Review of institutional guidance documents
• Examples
• References
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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
