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Risk Management in Clinical Trials REMOTE LEARNING

 REMOTE LEARNING - this course will be delivered to you live online from the UK. 

If you are wanting to book more than one person onto a course(s) please email courses@therqa.com

Course Information

This course offers the ideal training opportunity for moving into the field of risk management in clinical trials.  The course will be of value to those familiar with ICH Guideline for Good Clinical Practice (ICH GCP E6(R2)) and ICH Guideline on General Considerations for Clinical Studies (ICH E8(R1)) but aiming to apply the principles of risk management to clinical trials; and for those who have quality and or risk management experience from other disciplines. Delegates are expected to have some experience in the field of clinical trials and knowledge of the two ICH Guidelines prior to attending to maximise their learning in how to manage risks in clinical trials.  The course concentrates on the practicalities of clinical trial risk management.  Workshops give the delegates practical experience of using risk management techniques in a clinical trial context.  All of the tutors are seasoned quality professionals who can relate the theory to their own experiences.

 By the end of the course delegates will have

  •  A clear understanding of aims of ICH Guidance E6 and E8 regarding risk management in clinical trials
  • An idea of what can go wrong with clinical trials and how robust risk management approaches can help prevent serious non-compliance
  • An understanding of the roles and responsibilities for risk management in clinical trials
  • Explored a range of techniques to identify and manage risk in clinical trials, with examples and helpful documents
  • Developed networking contacts to further their auditing career

 Benefits include

  •  A clear understanding of the role of the quality professional in facilitating clinical trial risk management activities
  • Improved Good Clinical Practice compliance for your clinical trials by ensuring risks are identified and mitigated prior to developing into serious non-compliance

 This course is structured to encourage delegates to 

  • Discuss and develop ideas
  • Solve specific problems
  • Examine key aspects of risk management in clinical trials

This course is aimed at

  • QA Auditors who will be reviewing the risk management processes as part of their audits and need to have a better understanding of the process
  • Quality professionals who may be involved in the risk management processes
  • Project Managers who want to better understand how to identify compliance risks

Course Tutors

Cathy Dove
Director and Owner, Dove Quality Solutions (Course Principal)

Rosemarie Corrigan
EVP Global Quality, Worldwide Clinical Trials

Patricia Henley
Head of Research Governance and Integrity, London School of Hygiene and Tropical Medicine

Recent Feedback

"The course was conducted in a very much professional way in terms of sharing the material and relevant information well in advance, punctuality, well managed sessions and the contents. The trainers' experience was visible and the participants also had some very relevant queries and thoughts. The workshops conducted in groups in a remote workshop is something commendable - the switching over to separate meeting rooms was seamless and quick. While I understand the limitation of the time available, if some live examples can be discussed during the training, that would really help. Although I don't have a real experience in the clinical trail conduct, I could very well relate the explanations to my area of work. Thank you!!"
"Obviously a very experienced and knowledgeable speaker. Provides a jam packed presentation style that provides a significant amount of information providing background to the slide text."

Course Programme 

Please note this course will run in UK timezone.



 Day 1

 9.00 Welcome and Objectives
 9.35 Risk Management Regulatory Framework
Introduction to the clinical trial risk management process.  The concepts of risk management. A brief review of the regulations and guidelines that describe risk management requirements in clinical trials.
 10.30 Break
 10.50 Introduction to the CRASH 2 Trial
CRASH 2 was a non-commercial trial to investigate the effects of antifibrinolytic treatment on death and transfusion requirement in trauma patients.
 11.30 Identification of Critical to Quality Factors
How to determine what is critically important to the successful completion of the trial
 12.00 Lunch
 13.00 Workshop 1 - Identifying the Critical to Quality Factors for CRASH 2
 13.45 Pragmatic Approach to Risk in the Non-commercial Environment
Identification and management of clinical trial risk with limited staff and resources
 14.45 Risk Identification in the Commercial Environment
How to manage risk in a large, siloed environment making best use of the available data sources
 15.45 Break 
 16.00 Workshop 2 - CRASH 2 Risk Assessment
 17.15 End of day Q&A
 17.30 Close of day

 Day 2

 9.00 Q&A from Day 1
 9.15 Quality Tolerance Limits
What are the QTLs and how to define them
 10.00 Workshop 3 - Identifying QTLs for CRASH 2
 11.00 Break
 11.15 Risk Based Audit Programs
How to develop more effective audit programs focusing on the areas of highest risk to the conduct of clinical trials
 12.30 Lunch
 13.30 Hidden Trial Risks
Areas of risk that are often under-estimated in clinical trials
 14.30 Auditing Risk Based Monitoring Trials
How to adapt your site auditing techniques for RBM trials and determining the acceptability of clinical trial data
 15.30 Break
 15.45 Workshop 4 - Auditing a Site with Risk Based Monitoring
16.25 Final Q&A
16.45 Close of Course

Course Material

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. 

Please note this course will run in UK timezone.

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course 
  • Environmental benefits – less paper being used per course
  • Access to an online course group to enhance networking

You will need a stable internet connection, a microphone and a webcam. 

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