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. Deviations and Violations from the agreed upon protocol may very well affect Subject and Public safety in addition to the scientific validity of the research.
For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct. If and when a deviation or violation of the protocol is found, meaning that the protocol was not followed (PNF) it must be reported, reviewed and acted upon for Corrective and Preventative Action (CAPA). Also, the differences between and differing significance of “Deviations” and “Violations” must be clearly understood by all persons involved in the conduct of clinical research studies.
Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment
Charles H. Pierce, MD, PhD, FCP, CPI - Has 26+ years experience in the Clinical Research field and is an ACRP/APCR Certified Principle Investigator (CPI in 2003 - 2016). He is frequently actively involved in Webinars, courses, and workshops giving the clinical investigator and staff an understanding and appreciation of the ethics as well as the science and regulations governing clinical research with drugs or devices. The end must be knowledge and keen observation to ensure drug safety.