Course Description

There are big expectations when it comes to risk in clinical trials. ICH E6(R3) underscores the importance of adopting a risk-based approach and is a tool health authorities expect clinical research professionals to utilize. But are all risks the same? How do you know what risks can be tolerated vs. those requiring significant time and resources?

This web seminar will help learners gain a better understanding of risk and how to determine risk tolerance levels (acceptable ranges). ICH E6(R3) has modified the risk management framework of Quality Tolerance Limits to acceptable ranges which allows for more flexibility while maintaining the scientific rigor or the clinical trial. The pre-specified ranges will still take into account the participant safety and reliability of the trial results. In this training we will discuss setting these ranges and what to do when a deviation to a range occurs, along with documentation.

Learning Objectives

• Define risk
• State a commonly held myth about risk and explain why it is a myth
• Describe risk tolerance
• Describe the methodology for determining risk tolerance

Who Should Attend

• Clinical Operations Personnel
• Data Management Professionals
• Quality and Regulatory Affairs Professionals
• Study Managers
• Project Managers

Instructor

Susan M. Leister, M.B.A., Ph.D., CQA, CSSBB

Click here for complete trainer biographies

Registration Fees

$835*

*Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com 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 2.5 hours (0.25 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#: 0778-0000-24-063-L99-P. Released: 9/24. 

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