ACRP 2018 Meeting & Expo

114 - Writing, Monitoring, and Documenting Protocol Deviations: Practical Tips

Apr 28, 2018 10:15am ‐ Apr 28, 2018 11:15am


Credits: None available.

Members: $25.00
Standard: $75.00

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 the characteristics of an evaluable subject in a clinical research trial
  • Provide suggestions and clear examples for writing well-defined deviation descriptions
  • Identify study professionals who can a characterize and address protocol deviations

Speaker(s):

  • Sandra Hines, MS, CCRA, Project Manager, PRA Health Sciences
  • Annette Bernstein, MBA, CCRA, Sr. Manger, Quality Training Academy, Johnson & Johnson

Credits Available


Writing, Monitoring, and Documenting Protocol Deviations: Practical Tips

You must be logged in and own this session in order to post comments.