How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant
In this webinar you will learn how to prevent and handle protocol deviations and violations, also discuss the regulatory requirements for handling protocol deviations and violations and the importance of documentation that is required.
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Deviations and Violations from the agreed upon protocol may very well affect the scientific validity of the research. For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct.
As the Principal Investigator is responsible for the conduct of the study according to the protocol she/he signed, it is imperative that they ensure that all staff know the protocol and follow it to the letter. If and when a deviation or violation of the protocol is found, meaning that the protocol was not followed (PNF) it must be reported, reviewed and acted upon for Corrective and Preventative Action (CAPA). Also, the differences between and differing significances of "Deviations" and "Violations" must be clearly understood by all persons involved in the conduct of clinical research studies.
One of the problems in this area is that the regulations do not have clear definitions of what a protocol deviation or violation is but one must know that the FDA Compliance Guidelines makes up for this. This Webinar makes the case that all incidents of PNF should be discouraged and avoided by all sites and CROs as their standard.
It is important to see what the FDA regulations and the ICH GCP recommendations are in regard to PNF. Most importantly, when does a protocol deviation / change lead to a protocol amendment. There are differences in actions, reporting and consequences of deviations and violations and these will be discussed. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. To not follow the protocol is folly.
Why should you Attend: Protocol Deviations and Violations are one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data from a particular site or even a study. Forewarned is forearmed.
Areas Covered in the Session:
Who Will Benefit:
- How to know when the protocol is not followed (PNF)?
- What is the difference between a protocol deviation and a violation?
- Importance of the "Protocol" in the number of deviations occurring
- How to ensure that the protocol will be followed exactly?
- What is in the Regs about following the protocol?
- When may the Investigator make changes in the protocol?
- What are the causes of Protocol Deviations and Violations?
- How are Protocol Deviations managed?
- Examples of Protocol Violations and Deviations
- Principal Investigators and Sub Investigators
- Clinical Research Scientists (PKs, Biostatisticians)
- Research Managers
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting Staff
- QA / QC Auditors and Staff
- Study Monitors
- Clinical Research Data Managers
Charles H. Pierce MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects.
From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 48+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 27+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.
He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification’s to 2018). He is frequently actively involved in Webinars, courses and workshops giving the clinical investigator and staff an understanding and appreciation of the ethics as well as the science and regulations governing clinical research with drugs or devices. The end must be knowledge and keen observation to ensure drug safety.
Charles’ active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU’s). From experience and practical know-how the special needs of these units (from the floor plans to operational SOPs) has been of added value to those considering this venture. He has work experience in Device Studies and Pharmacovigilance. The later (PV) is of special interest as Phase I through Phase III do not guarantee drug safety. Actually this vigilance must start with the very first studies in human subjects.
Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) of which he was a Regent 1995-2000, Chairman of the 2001 annual meeting, and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU) of which he was a trustee (2007-2011) and chaired the successful 2010 annual meeting. He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).