Monday, June 24 • 3:30pm - 4:30pm
#155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-570-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how to complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organizational science which addresses human factors and transparency to enhance organizational learning and continuous improvement. This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future.

Learning Objectives

Identify evidence-based techniques for better defining causal factors in system failure; Recognize that those techniques which can be used now; Appraise how we should best develop these concepts, identify best practice and engage all stakeholders; Discuss how to volunteer to join the team aiming to improve the safety of the system for clinical research.


Brian Edwards, DrMed


Applying CAUSAL Analysis System Theory to the TGN1412 First-In-Human Clinical Trial
Brian Edwards, DrMed

Innovation in First-in-Human Safety
Howard Greenberg, DrMed, MD, MBA, MS

Investigators from the Warfarin-Stimulated Frail Hospitalized Patients Project
Nichola Crust, MSc


Nichola Crust

National Investigator, Healthcare Safety Investigation Branch
Nichola has worked at a strategic level in a variety of healthcare settings spanning primary and secondary care. Her roles have included professional nurse leadership and mentoring of nursing teams, mobilisation of new services including service and workforce redesign, and training... Read More →
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session