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.
This presentation is a replay from the ACRP Online Conference Library
Speakers: Sandra Hines, MS, CCRA - Janssen Neuroscience
Annette Bernstein, MBA, CCRA - Johnson & Johnson
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