In this GCP Webinar training, learn how to proactively predict and manage Protocol Deviation/Violation/Exception. Understand the guidance for implementation of “Protocol Not Followed” (PNF).
Why Should You Attend:
As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of “Protocol Not Followed” (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are expected to adhere to the study protocol. Instances of “Protocol Not Followed” (PNF) are not addressed in the CFR or other regulatory rules. The various terms used to describe PNF (violation, deviation, and exception) are open to different interpretations by the parties involved.
 
Areas Covered in the Seminar:

• How to define and manage Protocol Deviation/Violation/Exception.
• Proactive approaches to predict and prevent clinical trial protocol violations.
• Industry and FDA perspectives on Protocol Deviation/Violation/Exception.
• Discuss the current lack of unified definition for protocol deviation/violation/ exception.
• Define the term “Protocol Not Followed” (PNF).
• Explain the guidelines for the implementation of PNF to include capturing, reporting, and documentation.
• Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs.