The Association of Clinical Research Professionals

Writing, Monitoring, and Documenting Protocol Deviations: Practical Tips

Master your understanding of protocol deviations, one of the most common problems identified in FDA inspections and the main reason for the rejection of data from a site or study. Speakers will address actions necessary when a deviation is found and the importance of all persons involved in clinical trials understanding deviations. Leave with a solid grasp of the characteristics of an evaluable subject, who can identify a protocol deviation, and methods for writing clear deviation descriptions.

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This program is a recorded session from ACRP 2018