Webinar Replays

WR18 - Webinar Replay: Best of ACRP 2018: Writing, Monitoring and Documenting Protocol Deviations: Practical Tips

Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm


Credits: None available.


Description

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.

Learning Objectives

  • 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.

Speaker(s):

  • Sandra Hines, MS, CCRA, Project Manager – Strategic Solutions PRA Health Sciences , Janssen Neuroscience

Credits Available


Webinar Replay: Best of ACRP 2018: Writing, Monitoring and Documenting Protocol Deviations: Practical Tips Exam

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