Intelligent Approach to Risk-Based Monitoring to Improve Clinical Trial Quality

Duration: 90 Minutes
This course will provide opportunities to practice the necessary skills to apply a risk based approach to monitoring activities.
Risk-Based Monitoring to Improve Clinical Trial Quality
Product ID: 501268
In order to satisfy the regulatory requirements companies have to utilize a risk based approach. To maximize the benefits of a risk based approach, the drug / device development companies, CROs and other institutions are actively looking into practical implementation of risk based monitoring. A risk based approach has to be applied at all stages of the clinical trial process as risk based monitoring cannot be employed in isolation.

Objectives of the Presentation
By the end of this course you will be able to:
  • Review the basic principles of Risk Management
  • Utilize the basic principles to take a 'risk-based approach'
  • Document risks identified
  • Prioritize risks and plan mitigation actions where necessary
  • Outline the limitations of current monitoring practices
  • Differentiate between different types of monitoring
  • Describe the link between study level risk assessment and the monitoring plan
  • Identify risk triggers during monitoring
  • Share best practice
Why Should you Attend
Any clinical research professional embarking on a risk?based approach would benefit from attending this course. In order for a risk based approach to operate effectively all clinical trial disciplines e.g. monitors, CRAs, data management, project management statisticians, outsourcing, drug suppliers etc, should provide their unique input to all steps in the process.

Areas Covered
This course provides an understanding of risk management principles and makes the links between study level risk management and the implementation of risk based monitoring. This practical course allows opportunities to develop the skills necessary for implementation of a risk based monitoring approach. Along with identification and evaluation of risks to critical study data and clinical trial operations it is imperative to ensure the necessary pieces are in place. This course will allow participants to appraise their current processes, people and technology with a view to improving monitoring efficiency and enhancing patient protection while maintaining high quality data.

Who can Benefit
  • Clinical Operations Managers
  • Project Managers
  • Lead CRAs
  • CRAs
  • Data Managers
  • Statistical Personnel
  • Stakeholders in introducing a risk based approach within a company or institution e.g. outsourcing, clinical supplies
$300
Recorded Session for one participant
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  $450.00 Training CD
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  $550.00 Training USB Flash Drive
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Sue Fitzpatrick
Owner, Sue Fitzpatrick Associates
Sue Fitzpatrick has more than 30 years' Pharmaceutical Industry experience. She has been responsible for the management and audit of CRAs, CROs and clinical trials in a wide range of therapeutic areas. As former Director and Head of Education and Training at the Institute of Clinical Research she was responsible for the provision of training courses for the industry and for postgraduate courses in collaboration with several UK Universities. Sue is an accredited teacher with Cranfield University and continues her collaborations but as a consultant trainer. Sue conducts courses in many topics including risk based monitoring (RBM).

Sue is currently a Director of Redtree People and continues her work on enhancing competencies and standards, writing industry gold standards for CRAs in collaboration with COGENT the sector skills council. She was a member of the GCP committee of the Faculty of Pharmaceutical Medicine and helped develop a certification examination for physicians and other research personnel. She is a senior collaborative consultant for NNEdPro Cambridge Hub. She has authored many articles and books on clinical research, risk based/centralized monitoring and career development topics. Sue has recently published a book in Clinical and Healthcare Research with the Oxford University Press.

Jane Tucker
Risk Management Trainer and consultant, Sue Fitzpatrick Associates
Over the past 30+ years Jane has moved from routine data cleaning activities, via system validation on to training and data quality activities, eventually specializing, within her role as a Quality Risk Manager, in Risk Assessment and Management. Jane's Risk Assessment and Management expertise covered a range of areas from the R&D Management team, through individual departments and then clinical trial teams and process improvement projects, not forgetting software development projects, large and small. Over that period of time Jane has worked for a number of major Pharmaceutical companies and CROs, before retiring from one of the top pharmaceutical companies.

Jane has also been involved as a contributory author to a number of System Validation guidelines รข?? Computer Systems Validation, A Practical Guide 1998; Computerized Systems Validation in Clinical Research, A practical guide 2004 and most recently Validation and Management of e-Clinical Systems in Collaborative Clinical Trials 2015.

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.
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