Protocol Deviations: Documenting, Managing, and Reporting

Upcoming Courses
Course #: BI13799
January 27, 2020
9:00 AM - 11:00 AM Eastern
Course #: BI13862
May 11, 2020
1:00 PM - 3:00 PM Eastern

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.

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

Click here for complete trainer biographies

Registration Fees


Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-18-047-L01-P. Released: 10/18. 

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