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How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

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Industry :

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Course Description:

This GCP compliance training will discuss the regulatory requirements for handling protocol deviations and violations and the importance of documentation that is required. The presenter will provide specific examples and proven tips for handling instances of protocol violations.

This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful or knowing misconduct on the part of the investigator is handled.

Why should you Attend?

Following exactly the signed and approved (IRB + PI) Protocol to the letter is the goal and mandate of all clinical research. This, in fact, is included on the FDA Form 1572.

It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. Most importantly, when do 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.

Areas Covered:

  • The Primacy of the study Protocol.
  • What are Protocol Deviation and other terms / categories.
  • The many cause of protocol deviations.
  • The Regulatory requirements for handling protocol deviations and violations.
  • The importance of documentation of protocol deviations as well as violations.
  • How to define and handle instances of PNF.
  • What is the reason different IRBs define deviations and violations differently.
  • What is the basis of the difference between a Deviation and a Violation.

Who will Benefit?

This Webinar will provide invaluable assistance to the pharmaceutical industry and to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:

  • Principal Investigators / Sub-investigators.
  • Clinical Research Scientists (PKs, Biostatisticians,)
  • Safety Nurses
  • Clinical Research Associates (CRAs) and Coordinators (CRCs)
  • Recruiting staff
  • QA / QC auditors and staff.
  • Clinical Research Data managers

Registration Options


Avail 12 months unlimited access for a single user.


Material shipped within 15 days post webinar completion & get life time access for unlimited participants.



Speaker Details

Dr. Charles Pierce

Dr. Charles Pierce

Clinical Research

Dr. Charles Pierce has served as a family physician (7 years as an ER doc) and 23+ 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. 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

Refund Policy



Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@complyarena.com or call +1-888-222-5917 (Toll Free).