Overview: 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.
Attend this Webinar to understand the proactive approach to define and manage Protocol Deviation/Violation/Exception. What is the approach to predict and prevent it.
Proper documentation and reporting of PNF as they occur is helpful for investigators and study sponsors, as these data can be used to determine the need for amendments to the protocol and/or the related documents. The monitoring of the frequency and nature of PNF can also be used as a quality assurance measure for the site. A noncompliance with the study protocol should be reported as soon as it is identified. This is consistent with Good Clinical Practices (GCPs).
This Webinar will also discuss the guidelines for implementation of PNF to include capturing, reporting and documentation.
Areas Covered in the Session: - 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
- Unanticipated problems
- Unanticipated problems vs. adverse events
- Protocol deviations, violations (major & minor), exceptions
Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Pharmaceutical, Biotechnology, CROs and Research Facilities Conducting Clinical Trials including:
- Sponsor Senior Management
- Project Managers
- CRA Managers
- QA/Compliance
- CRAs
- Project management
- Investigators
- Regulatory affairs
