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

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.

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.

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 in the Seminar:

• 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

Instructor Profile:

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. Dr. Pierce has served as an advisor to several clinical research organizations.

He is presently the Medical Director of the Metabolic and Atherosclerotic Research Center which is part of Medpace, Inc. He has been in the Clinical Research Industry for 20 years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.