A reason often quoted by the FDA investigators for rejecting a clinical data from a site or a study is Protocol Deviations and Violations. The basis for this action is that Deviations and Violations from the agreed upon protocol have the potential to mar the scientific validity of the research. The key to avoiding being in such a situation is putting in place a well-written protocol into which the role of all the Inclusion and Exclusion criteria in subject enrollment is taken into consideration.
The responsibility of ensuring that the study is conducted in complete adherence to the protocol signed being the Principal Investigator’s; it is obligatory on their part to ensure that everyone involved in the study knows the protocol and follows it to a T. In situations where the Protocol was Not Followed (PNF), i.e., a deviation or violation of the protocol is discovered; reporting, reviewing and carrying out Corrective and Preventative Action (CAPA) are mandatory.
It is also necessary to ensure that everyone involved in the conduct of clinical research studies is made aware of the differences between “Deviations” and “Violations” and how their significance differs between each other.
The FDA’s Compliance Guidelines
A major challenge in sticking to this action is that the FDA’s regulations are hazy in their definitions of a protocol deviation or violation. However, the FDA has made its Compliance Guidelines available as a reliable tool for reference.
Anyone carrying out a clinical study needs to be aware of both the FDA regulations and the ICH GCP recommendations vis-à-vis PNF. They need to be aware of how to determine when a protocol deviation/change leads to a protocol amendment.
Learning on how to prevent or handle protocol deviations
All these aspects of how to prevent or handle protocol deviations will be the subject of a highly educative and interesting webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.
Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena, who 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; will be the speaker at this webinar. In order to gain a full understanding of the highly relevant topic of how to prevent or handle protocol deviations; please register for this webinar by visiting GCP and Regulatory Compliant
Dr. Pierce will give participants of this webinar the all-important understanding needed to identify deviations from protocols and what to do about them, because it is always better for those conducting clinical studies to be forewarned and be forearmed than to take firefighting steps after a problem erupts, which could place a heavy strain on their resources and render the whole exercise futile. He will also offer clarity on the differences in the various actions, reporting and consequences of deviations and violations.
Dr. Pierce will cover the following areas at this webinar:
o How to know when the protocol is not followed (PNF)?
o What is the difference between a protocol deviation and a violation?
o Importance of the “Protocol” in the number of deviations occurring
o How to ensure that the protocol will be followed exactly?
o What is in the Regs about following the protocol?
o When may the Investigator make changes in the protocol?
o What are the causes of Protocol Deviations and Violations?
o How are Protocol Deviations managed?
o Examples of Protocol Violations and Deviations.
This session will benefit those in the thick of clinical studies, such as 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, and Clinical Research Data managers.