Defining and Managing Protocol Deviation/Violation/Exception

Instructor: Sandy Rizk Soliman
Product ID: 701670
  • Duration: 60 Min

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Read Frequently Asked Questions

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.

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 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.

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

Instructor Profile:
Sandy Rizk Soliman, Co-founder and Chief Executive Officer of Research Alliance LLC.; a consulting firm focused on global clinical trial solutions, tools, and training to streamline drug development to market. The firm advises clinical research sites, pharmaceutical drug development, biotech, medical device, and contract support organizations. Sandy began her journey in Clinical Research over 13 years ago. Her experience spans key aspects in multiple therapeutic areas and phases of drug development in the roles of study coordinator, site monitor, clinical research project manager, and trainer. She has effectively provided clinical research education and customized training in areas of the clinical research process, the FDA regulations, GCP (Good Clinical Practice) and the International Conference of Harmonization (ICH) guidelines.

Sandy has created company-wide SOPs for a variety of relevant processes related to clinical research including, but not limited to, Informed Consent Process, Scheduling, Follow-up, Adverse Effect Reporting, etc. She has also been pivotal in coordinating, arranging, and managing the infrastructure of the company policies and procedures. She has also been awarded the National Association of Women Business Owners – NYC Chapter Phoenix Award 2008 and the National Association of Women Business Owners – NYC Chapter Golden Glove Award 2008.

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