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This handbook will try to summarize the Protocol Deviation process, list the involved parties, describe the various methods and actions provisioned by regulations, and discuss tools and procedures that may alleviate the burden and improve the outcome of Protocol Deviations management.
Protocol Deviation (PD): Any change, divergence or departure from the study design or procedures defined in the protocol. Important Protocol Deviation (IPD): A PD that may significantly impact the completeness, accuracy, and/or reliability of the study data or that may significantly affect a subject’s rights, safety, or well-being. For example,
Clinical study protocols are conducted according to the International Council for Harmonization guidance on Good Clinical Practice (GCP) which outlines safeguards for the rights, safety and well-being of participants.
10 Οκτ 2024 · In this detailed guide, we will explore what protocol deviations are, their impact on clinical trials, common causes, and best practices for minimizing deviations and managing them when they do occur.
29 Ιαν 2024 · Complying with the approved study protocol is a key principle of this guidance. Any departure from the approved trial protocol is a protocol deviation. Protocol deviations may be considered important (major) or non-important (minor).
16 Ιουν 2020 · Protocol deviations occur when there’s a departure from the procedures or schedules outlined in a clinical trial’s protocol. This isn’t just about paperwork—it directly impacts patient safety, data integrity, and the trial’s ability to meet its endpoints.
20 Μαΐ 2016 · This article expands on the position paper to include concrete tools for the management of protocol deviations, including best practices for detection, classification, mitigation, and management of protocol deviations with a goal to reduce the impact on subject safety and data integrity.
