Clinical Trial Monitoring Training Course: Understand the Importance of Compliance With the Latest Gcp Standards, and How New Monitoring Approaches in Clinical Trials Are Being Employed for the Future
Dublin, May 02, 2023 (GLOBE NEWSWIRE) -- The "Clinical Trial Monitoring Training Course" conference has been added to ResearchAndMarkets.com's offering.
With regulatory inspectors increasingly finding GCP issues with monitoring clinical trials, it is becoming even more important for the biopharmaceutical industry, study sites, and CROs to employ efficient and accurate strategies for monitoring clinical trials.
Also, the global COVID-19 pandemic has changed how clinical trials are monitored, resulting in remote and centralized monitoring techniques at the forefront of monitoring. This has created an environment that requires monitors to not only purely focus on-site visits. Regulatory authorities promote these alternative ways of monitoring trial data and the future is likely to include a more hybrid monitoring approach.
This course will assure monitors understand the importance of compliance with the latest GCP standards, and how new monitoring approaches in clinical trials are being employed for the future.
Ensure GCP compliance for monitoring clinical trials including during Covid and monitoring approaches for the future
Evaluate the development of monitoring plans through protocol analysis for remote risk management
Discuss tools and risk evaluation approaches for remote monitoring
Ensure appropriate site selection, initiation, monitoring, and close-out visits are carried out including during a pandemic.
Review sponsor and CRO oversight of monitors
Who Should Attend:
Clinical research associates (CRA)
Clinical Trial Managers
Study site assistants
Those responsible for oversight of monitoring
Investigators seeking to move into clinical trial monitoring
This course will benefit those involved in the monitoring of clinical trials, including new and soon-to-be monitors. This will also be an ideal refresher including how monitoring has changed because of the pandemic and those responsible for oversight of monitors.
Key Topics Covered:
GCP Compliance considerations for monitoring clinical including during a pandemic and the future
What is the role of the monitor/CRA to comply with GCP and changes as a result of Covid and technology innovation?
The monitoring role in the context of having a quality system for clinical trials
ICH E6R3 and update and impact on monitoring
Criteria for selecting suitable sites
Site Feasibility Assessment
Preparing for site initiation
Agenda and content of site initiation visit report to comply with GCP
Risks of inappropriate site initiation & resulting issues
Monitoring Visit Procedures
Preparing for site monitoring
Important consideration during SDV and virtual clinical trials
Identifying issues and developing solutions
Monitoring visit report to comply with GCP
Study close-out visits
Preparing for site closure
Final preparing of documentation and entering data
Content of closeout visit and follow-up to comply with GCP
Planning Patient recruitment strategies
Optimising Recruitment to clinical trials
Common recruitment problems in clinical trials and how these may be managed
Oversight of monitoring
Co-monitoring visits including by the sponsor and CRO management
Preparing a sponsor monitoring oversight visit
Follow-up with the monitor/CRO
GCP and Documentation and Archiving
Requirements of the GCP Inspectors
Reporting Serious Breaches and preventing Fraud: What monitors need to know
What are the signs a monitor should look for Serious Breaches and Fraud?
What actions should the monitor take?
How to report serious breaches
Preparing for Audit and Inspection visits to comply with GCP
How to prepare effectively for a study site audit and/or regulatory inspection
What do QA departments and inspectors look for?
A brief review of regulatory authority inspections findings
Pharmaceutical QA and Training Consultant
University of Cardiff
Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years' experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017.
For more information about this conference visit https://www.researchandmarkets.com/r/lswn9m
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