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:
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
Who Will Benefit:
Principal Investigators and sub investigators
Clinical Research Scientists (PKs, Biostatisticians)
Clinical Research Associates (CRAs) and Coordinators (CRCs)
QA / QC auditors and staff
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. Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. 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.