What is the Role of Protocol Deviations and Violations to Maintain GCP and Regulatory Compliance as Well as a Clean Audit?

Event Information
Product Format
Prerecorded Event
Charles H Pierce, MD, PhD, FCP, CPI
90 minutes
Product Description

Role of Protocol Violations and Deviations in Maintaining GCP, Regulatory Compliance and Conducting a Clean Audit

“Not following the protocol” – its nature, frequency and evidence has gained increased importance, thanks to the increasing frequency of real-time FDA audits. FDA investigators have identified protocol violation and deviation as one of the commonest problems which lead to rejection of clinical data from particular sites and studies.

These violations and deviations from agreed protocol are likely to affect the scientific validity of the research. Thus, a well written protocol that takes the role of all the inclusions and exclusions criteria into account in subject enrollment is vital for a study conduct free of deviations. A major challenge is to know the differences between and differing significances of “Deviations” and “Violations”. This must be clearly understood by all persons involved in the conduct of clinical research studies.

Join this session by expert speaker Charles H. Pierce, MD, PhD, FCP, CPI to understand the role of protocol deviations and violations in maintaining GCP and regulatory compliance.

Session Highlights

  • When and how to know if PNF is not followed?
  • What’s the difference between protocol violation and deviation?
  • ‘Protocol’ – importance in the occurring number of deviations?
  • How to see to it that exact protocol is followed?
  • What is the content in regulations on following protocol?
  • When can investigators make changes in protocol?
  • What are the causes behind protocol violations and deviations?
  • How to manage protocol deviations?
  • What are the common examples of protocol violations and deviations?

Learning Objectives (for those wishing CME)

  • Primacy of the Study Protocol
  • Identify when Protocol is Not Followed (PNF) and what is to be done if this happens
  • Difference between a Protocol Deviation and Protocol Violation
  • PNF instances classification and why it might be helpful
  • When and how to report Deviations/Violations

Reference Documents:

  • Pierce, C.H., Greenberg, H.E. Investigator Responsibilities in Clinical Research: ICH Viewpoint. The MONITOR, 25(5), 33-38, September 2011
  • Pierce, C.H., Common GCP Violations and Site Mistakes: How to Avoid them, The MONITOR, 26(5), 55-59, Sep 2012  
  • Pierce, C.H., Importance of Data and Safety Monitoring in Clinical Research, The MONITOR, 26(7), 43-47, Dec 2012
  • Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), ..., Sep 2009
  • FDA Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees.  March 2006yu67

Who Should Attend

This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry who may be called upon to Conduct Clinical Trials including: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/Compliance persons. In CRO’s and sites, those benefiting the most would be: Principal Investigators and sub investigators, Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), QA / QC auditors and staff, and Clinical Research Data managers.

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About Our Speaker

Charles H Pierce

Charles H. Pierce, MD, PhD, FCP, CPI

From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal...   More Info
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