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.
Key Objectives:
- 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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
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 and 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
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of CardiffDr 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.
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
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.
