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As 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. 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.Forewarned is forearmed.
• Demonstrate the primacy of the Study Protocol
• Determine when the Protocol is not followed and what to do if this happens
• Describe the difference between a protocol deviation and a protocol violation
• Explain the ways why following the Protocol as written will prevent Warning letters or 483s
• Construct an SOP on how and when to report a protocol Deviation/Violation
• Compare the impact of a Protocol Deviation vs. a Violation
Deviations and Violations from the agreed upon protocol may very well affect 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 enrollmentis 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 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.
• 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 what a ‘Protocol Deviation’ is or is not?
• 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
This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry who may be called upon to Conduct Clinical Trials: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/Compliance persons. In CRO’s and sites, those benefiting the most would be: Principal Investigators and sub investigators, Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), QA / QC auditors and staff, & Clinical Research Data managers.
Clarissia L. Harris, CPP, MBA is a payroll professional with 25 years of experience in both teaching and managing payroll. She has taught several Certified Payroll Professional (CPP) training courses throughout the United States. Her extensive work experience includes Georgia State University, Science Application International Corporation, KPMG and IBM Internet Security Company. Currently, she is a Payroll Manager for a large Financial Company in Atlanta Georgia. Also presently, she is a payroll instructor at a local university in Atlanta. Clarissa has also received several Merit of Citation awards from the American Payroll Association