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.
List three individuals who can identify and are responsible for documenting and following up on protocol deviations.
Document a protocol deviation, determine next steps to be taken and develop a corrective action plan.
Provide examples to educate the clinical trial staff to prevent the recurrence of a protocol deviation.
Project Manager – Strategic Solutions PRA Health Sciences ,
Webinar Replay: Best of ACRP 2018: Writing, Monitoring and Documenting Protocol Deviations: Practical Tips Exam
1.00 - ACRP Credits
1.00 - CME Credits
1.00 - CNE Credits
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