Clinical Trial Monitoring Training Course: Efficient Strategies for Monitoring Clinical Trials Amid Increasing GCP Scrutiny (ONLINE EVENT: July 21-22, 2025) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Clinical Trial Monitoring Training Course" training has been added to ResearchAndMarkets.com's offering.

This highly interactive course, which includes group discussions, ensures that monitors not only understand the importance of compliance with the latest GCP standards but also gain insights into how new monitoring approaches are shaping the future of clinical trials.

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 the ways clinical trials are monitored and resulted 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.

Benefits of attending

• 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:

• Monitors
• Clinical research associates (CRA)
• Clinical trial managers
• Study coordinators
• Project managers
• Research nurses
• Study site assistants
• Those responsible for oversight of monitoring
• Investigators seeking to move into clinical trial monitoring

Certifications:

• CPD: 12 hours for your records
• Certificate of completion

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:

Day 1

ICH GCP R3 Compliance considerations for monitoring clinical trials for the future

• What is the role of the monitor/CRA to comply with GCP and changes as a result of the pandemic and technological advances?
• The monitoring role in the context of having a quality system for clinical trials
• ICH E6R3 and update and impact on monitoring

Site selection

• Criteria for selecting suitable sites
• Site Feasibility Assessment

Site initiation

• 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

Day 2

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, documentation and archiving

• Requirements of the GCP Inspectors
• TMF considerations

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

Speakers:

Laura Brown
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 training visit https://www.researchandmarkets.com/r/8t7rcw

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.