The Association of Clinical Research Professionals

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

Pricing With Contact Hours

Member: $15 | Nonmember: $75

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This course is approved for 1.0 ACRP contact hours. Accreditation Details

Webinar Replay Expires November 6, 2019.

Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

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Webinar Replay Expires November 6, 2019.

Course 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. Speaker 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.

Upon completion of this Webinar, attendees should be able to:

  1. List three individuals who can identify and are responsible for documenting and following up on protocol deviations
  2. Document a protocol deviation, determine next steps to be taken and develop a corrective action plan
  3. Provide examples to educate the clinical trial staff to prevent the recurrence of a protocol deviation