Risk Management in Clinical Trials



ICH Q9 – Quality Risk Management has been present as an FDA Guidance
Document for almost 10 years, and this advocates the utilization of a risk assessment and then risk analysis methodology across all aspects of the pharmaceutical industry; which of course includes R&D and clinical trials. This risk management methodology achieves identification of risks, an analysis step and then deciding actions to be taken on the most significant. This process ensures that resources are not wasted on doing things that are not delivering benefit in mitigating significant risks.

This webinar will refresh basic Risk Management methodology and then establish how this fits in with the standard stages of a clinical trial. Regulatory inspectors will now expect to see evidence of a risk based approach to a clinical trial, and this course will address the topic of documentation to be created.

Areas to be Covered:

Risk management methodology
Utilize the basic principles to take a ‘risk-based approach’
Document risks identified
Prioritise risks and plan mitigation actions where necessary

Who will Benefit:

Data management Teams
Clinical Research Associates
Project Managers
Academic Research Organizations’ Staff
Representatives of any CROs or other contractors (ePRO etc) who will be supporting clinical trials
Researchers within a healthcare setting
And all clinical research professional embarking on a risk-based approach

Jane Tucker

Jane Tucker :
Over the past 28 years Jane has moved from routine data cleaning activities, via computer system validation onto training and data quality activities, eventually specializing in Quality Risk Management. Jane has worked for a variety of large pharmaceutical companies and CROs before retiring from GlaxoSmithKline. Jane now operates as a Risk Management Trainer and Consultant, specializing in Study Level Risk Management and Risk Based Monitoring as well as facilitation of risk assessment workshops.

Sue Fitzpatrick :
Sue Fitzpatrick joined the Pharmaceutical Industry in 1980. She has been responsible for the management and audit of CRAs and clinical trials in a wide range of therapeutic areas. As former Head of Education and Training at the Institute of Clinical Research she was responsible for the provision of training courses for the industry and postgraduate courses in collaboration with several UK Universities.

Sue continues her collaborations and is an accredited teacher with Cranfield University. Sue is currently a Director of Redtree people working on employability skills to help new entrants enter the sector. She has authored many articles and books on clinical research and career development topics. Sue is currently working on a book in Clinical and Healthcare Research for publication with the Oxford University Press.


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  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance