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

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Online Compliance Panel   

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Clinical Operations Personnel/Managers, Project Managers, CRA's, Data Managers, Statistical Personnel

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Seminar Summary:

CROs and sponsors serious about driving clinical trial quality, efficiency, and oversight, are aware of the FDA guidance:  (see full course description)

 

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Training Course Syllabus:


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
Leveraging risk insights to increase the quality of trial design
Share best practices

Why Should you Attend

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.

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. The FDA and EU regulatory authorities also support clinical trial sponsors to use risk-based site monitoring. For example, the revised ICH GCP guideline R2 Addendum, the EU Clinical Trial Regulation and FDA monitoring guideline all cover risk based monitoring.

Areas Covered

Define risk based monitoring for clinical trials
Define the regulations and guidelines which cover risk based monitoring
Understand risk based monitoring tools and methodology used in clinical research projects
Explore the roles and responsibilities of those involved in risk based monitoring
How to plan risk based monitoring approaches for clinical trials
Understand how to identify and evaluate study site and protocol risks for targeted SDV
Learn how to identify critical data
Develop and apply risk monitoring in your clinical trials
Evaluate the risk indicator and set thresholds
Learn how to document risk based monitoring in the monitoring plan
Hear best practices of these new risk requirements
Evaluate industry think tank trends (TransCelerate, CTTI)

Who will Benefit

Clinical Operations Personnel/Managers, Project Managers, CRA's, Data Managers, Statistical Personnel, Stakeholders in introducing a risk based approach within a company or institution e.g. outsourcing, clinical supplies, Clinical Development Managers and Personnel, Clinical Investigators and Staff, Clinical Research Associates, Clinical Research Archiving and Document Management Personnel, Quality Assurance Managers and Auditors, CROs using Laboratories to Analyze Clinical Trial Samples, Project Management, Sponsors and Non-Commercial Sponsors, Consultants, Sponsors/CROs Clinical Operations, Clinical Quality Compliance and Quality Assurance Professionals

Seminar Summary:

CROs and sponsors serious about driving clinical trial quality, efficiency, and oversight, are aware of the FDA guidance:  (see full course description)

print this agenda print agenda for the Intelligent Approach to Risk-Based Monitoring to Improve Clinical Trial Quality Webinar training seminar

 view dates and locations for this seminar

 

 

 

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