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Handling Protocol Deviations and Violations to Be GCP and Regulatory Compliant

Duration : 90 Minutes

Dr. Charles H Pierce,

Charles H Pierce is Medical Director of Pierce One Consulting. 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 Read more

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. This talk, by a certified physician investigator, will go over the regulations in a user friendly way. In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”.

If and when a deviation or violation of the protocol is found, 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. Also, learn when does a protocol deviation / change leads to a protocol amendment.. 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.

With the increasing frequency of real-time FDA audits, the importance of the nature and frequency of evidence of "Not following the Protocol" has gained increasing importance.

Course Objectives:

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.

Course Outline:

• 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
• 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

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• 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.

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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