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About us
Risk Management in Clinical Trials
Course Information
Immerse yourself in the realm of clinical trial risk management with our comprehensive training programme, designed as an ideal pathway into this field. Tailored for individuals familiar with ICH Guidelines for Good Clinical Practice (ICH GCP E6(R2)) and ICH Guideline on General Considerations for Clinical Studies (ICH E8(R1)), this course pivots towards applying risk management principles to clinical trials. It's equally beneficial for professionals with quality or risk management experience from diverse disciplines. Prior experience in clinical trials and familiarity with the ICH Guidelines is recommended.
Practical Emphasis:
Our course focuses intensively on the practical aspects of clinical trial risk management. Engage in workshops designed to provide firsthand experience in deploying risk management techniques within a clinical trial context. Guiding you through this journey are seasoned quality professionals, imparting theoretical knowledge through their rich practical experiences.
Key Learning Outcomes:
By the course's conclusion, delegates will:
- Gain a crystal-clear understanding of the objectives outlined in ICH Guidance E6 and E8 concerning risk management in clinical trials
- Uncover potential pitfalls in clinical trials and learn how robust risk management strategies can prevent serious compliance issues
- Understand the roles and responsibilities pertinent to risk management in the context of clinical trials
- Explore a range of techniques to identify and mitigate risks in clinical trials, reinforced with practical examples and supportive documents
- Expand your professional network, fostering opportunities for career advancement in auditing.
Benefits:
You will acquire:
- A thorough comprehension of the quality professional's role in facilitating clinical trial risk management activities
- Enhanced compliance with Good Clinical Practice standards by proactively identifying and mitigating risks before they escalate into serious compliance issues.
Interactive Structure:
Structured to foster active participation, delegates are encouraged to:
- Engage in vibrant discussions, idea development, and problem-solving
- Examine critical aspects of risk management within the context of clinical trials
This course is tailored for:
- QA Auditors tasked with reviewing risk management processes during audits, seeking a deeper understanding of the process
- Quality professionals involved in risk management processes
- Project Managers aiming to better grasp the identification of compliance risks within clinical trials
Tutors
Tutors will be comprised of (click the photos for biographies):
Rosemarie Corrigan
Rosemarie holds the position of EVP Global Quality at Worldwide Clinical trials where she directs and oversee quality and compliance programs for all areas of the Worldwide organization encompassing QMS, quality risk management, audit, training, standards and controlled documents, data integrity, audit and inspection readiness, process improvement, and quality metrics. Previously Rosemarie was the Chief Quality Officer at Nordic Nanovector, where she established the QA strategy and operations for development of radiopharmaceutical products.
Rosemarie holds a Masters in Bioethics and Medical Law from St Mary's University, London, and a Batchelor of Science in Biochemistry from University College Galway. She is eligible to be an QP for IMPs. She is a Fellow of Research Quality Assurance and Fellow of Royal Society of Biology. She is the current chair of RQA GCP committee.
Cathy Dove
Cathy Dove is a Quality & Risk Management Industry expert, providing risk and quality management consultancy along with GCP audits and bespoke training to a range of Pharma and Biotech clients. She is an RQA GCP Committee member and member of the EFGCP Quality Working Group, working within Clinical Quality Compliance and Risk Management.
Cathy has over 30 years Global Pharmaceutical Clinical Research expertise (Phase I-IV) both from Pharma and CRO and is also a pharmacist. During her career, Cathy has held various global senior leadership positions (including 2 years based in Singapore). Her responsibilities included project quality management, internal audits across all Clinical Research Services, preparation, hosting, and follow-up of inspections from all major regulatory inspectorates and sponsor audits.
As an independent consultant Cathy continues to support clients with inspection readiness, risk and quality management projects, sponsor oversight and vendor audits, complex system and for cause site audits and bespoke training courses.
Cathy has been a course tutor for the RQA GCP Auditing Course for over 20 years and is the course principle for the Risk Management in Clinical Trials course.
Patricia Henley
Associate Director, GD Quality Management (GCP), Regeneron Pharmaceuticals Inc
View pop upPatricia Henley
Patricia has over 20 years of experience in clinical research within a variety of roles. Patricia is a Fellow of the Research Quality Association, where she is an active member of the GCP Committee.
Programme
Please note timings may be subject to alteration.
Day 1
09:00
Welcome and Objectives
09:35
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
09:00
Q&A from Day 1
09:15
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
Extra Information
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.
Development Level
Develop
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Introduction to Quality Risk Management (QRM) elearning
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Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet