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About us
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.
Recommended Products
Booklets
Good Clinical Laboratory Practice (GCLP)
Good Clinical Practice Regulatory Authority Inspections
Management of the Training and Competency of Personnel in GxP and Research Environments
Quality Risk Management
Courses
P02 Good Clinical Practice Auditing - Principles and Practice
P08 The Auditing Course
P10 Implementing Good Clinical Laboratory Practice
P21 Audit Programmes and Risk Assessment
P34 Practical Approach to Auditing Systems and Processes
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP09 The Remote Auditing Course REMOTE LEARNING
RP10 Implementing Good Clinical Laboratory Practice REMOTE LEARNING
RP14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment REMOTE LEARNING
RP21 Audit Programmes and Risk Assessment REMOTE LEARNING
RP34 Practical Approach to Auditing Systems and Processes REMOTE LEARNING
eLearning Products
Introduction to Good Clinical Laboratory Practice (GCLP) elearning
Introduction to Good Clinical Practice (GCP) elearning
Introduction to Managing an Audit Programme elearning
Introduction to Quality Risk Management (QRM) elearning
Introduction to the Audit Process elearning
