“Not following the protocol” – its nature, frequency and evidence has gained increased importance, thanks to the increasing frequency of real-time FDA audits. FDA investigators have identified protocol violation and deviation as one of the commonest problems which lead to rejection of clinical data from particular sites and studies.
These violations and deviations from agreed protocol are likely to affect the scientific validity of the research. Thus, a well written protocol that takes the role of all the inclusions and exclusions criteria into account in subject enrollment is vital for a study conduct free of deviations. A major challenge is to know the differences between and differing significances of “Deviations” and “Violations”. This must be clearly understood by all persons involved in the conduct of clinical research studies.
Join this session by expert speaker Charles H. Pierce, MD, PhD, FCP, CPI to understand the role of protocol deviations and violations in maintaining GCP and regulatory compliance.
Learning Objectives (for those wishing CME)
Who Should Attend
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 including: 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, and Clinical Research Data managers.
Charles H. Pierce, MD, PhD, FCP, CPI
From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal...
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