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Archive: Protocol Deviations: Documenting, Managing, and Reporting

Course #: BI14111
November 10, 2020

Course Description

According to both U.S. regulations and the ICH GCP E6 Guideline, Clinical Investigators are required to conduct a clinical trial in compliance with the investigational plan/protocol. Protocol deviations should not be implemented without sponsor agreement and the prior approval/favorable opinion from the IRB/IEC, except when necessary to eliminate an immediate safety issue for research subjects. However, unapproved protocol deviations occur in every study and at every site. There is a growing recognition within the industry as to the importance of appropriately managing protocol deviations. This web seminar provides tips and strategies to help participants anticipate, manage, and minimize the impact of protocol deviations. Investigators and Clinical Research Associates (CRAs) will learn how to appropriately document and report protocol deviations, with a focus on preventing recurrence. Internal study team members will learn how to implement a structured approach to managing significant deviations that impact subject safety and/or data integrity.

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Learning Objectives

  • Describe the components of protocol deviation documentation and reporting
  • Identify stakeholder roles in the management of protocol deviations
  • Describe a process to proactively identify, track, and evaluate deviations for greater effectiveness in study management

Who Should Attend

  • Sponsor/CRO Project Managers
  • Sponsor/CRO Study Managers
  • Sponsor/CRO Clinical Research Associates
  • Sponsor/CRO Clinical Research Associate Managers
  • Clinical Investigators
  • Clinical Research Coordinators
  • Quality Assurance Professionals


Marla Hoelle, B.S.N., R.N., C.C.R.A., ACRP-PM., P.M.P.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.