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ACRP 2022

132 - Risk Management: From Framework to Implementation

Apr 23, 2022 10:15am ‐ Apr 23, 2022 12:15pm

Expiration Date: May 31, 2024

Credits: None available.


In 2016, ICH E6(R2) stated that “the quality management system should use a risk-based approach with the following: critical process and data identification, risk identification, risk evaluation, risk control, risk communication, risk review and risk reporting.” Six years later, clinical trial execution has become even more complex - scientifically, technologically, and environmentally, and with complexity has come increased risk to quality (patient safety, rights and well-being and data fit for purpose, absent of errors that matter for decision-making) that must be controlled. Today, many organizations are still grappling with establishing a systematic approach for identifying and managing risks that come with the execution and oversight of clinical trials. But building a strong risk management plan enables the sponsor to build quality into trial operations. Providing a plan to a health authority inspector, in turn, enables them to assess whether the sponsor proactively identified and controlled clinical trial risks before and during the clinical trial.In this Master Presentation, risk management concepts and implementation approaches will be discussed and practiced. Using hypothetical case studies, participants will have hands-on experiences with designing a proactive approach for the identification and management of risks which meets the expectations of ICH E6(R2). Participants will leave with knowledge and access to materials that will enable the clinical trial-related design and implementation of a risk management plan for a clinical trial.

Learning Objectives:
  • Explain the systematic approach for clinical trial risk management expectations in relation to ICH E6(R2)
  • Apply a risk management framework to develop a risk management plan for a clinical trial
  • Implement a systematic approach for effective execution of clinical trial risk management


  • Mary Brantner, BS, MS, Executive Director, Head of Global Development Operations, Mallinckrodt Pharmaceuticals
  • Leslie Sam, Principal Consultant, Risk Management and Issue Management Practice Lead, Wool Consulting Group


  • 2.00 - ACRP Credits

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