The "Clinical Trial Monitoring Training Course" has been added to ResearchAndMarkets.com's offering.
The biopharmaceutical industry, study sites, and Contract Research Organizations (CROs) are increasingly encountering GCP (Good Clinical Practice) issues in monitoring clinical trials, driving the need for efficient and accurate monitoring strategies.
The global COVID-19 pandemic has significantly altered clinical trial monitoring practices, pushing remote and centralized monitoring techniques to the forefront. As regulators advocate for these alternative monitoring methods, the industry anticipates a shift towards a hybrid monitoring approach combining conventional site visits with innovative digital techniques.
This interactive course is designed to equip monitors with a comprehensive understanding of the latest GCP standards and innovative monitoring approaches that are setting the stage for the future of clinical trial management. Participants will engage in group discussions that emphasize the critical importance of compliance while exploring the transformative impact of new monitoring methodologies.
Key Benefits of Attending:
- Ensure adherence to GCP standards for effective clinical trial monitoring, accounting for changes influenced by the COVID-19 pandemic and future monitoring strategies.
- Evaluate the development of monitoring plans through detailed protocol analysis, enabling robust remote risk management.
- Discuss advanced tools and strategies for risk assessment in remote monitoring environments.
- Ensure proper execution of site selection, initiation, monitoring, and close-out visits, especially under pandemic conditions.
- Review the oversight practices of sponsors and CROs in relation to monitoring personnel.
Certifications Offered:
- Earn 12 CPD hours for your professional records.
- Receive a certificate of completion to validate your attendance and learning.
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
Key Topics Covered:
Day 1
ICH GCP R3 Compliance considerations for monitoring clinical trials for the future
- Role of the monitor/CRA
- Monitoring role within a quality system
- ICH E6R3 update impact
Site selection
- Criteria for site selection
- Site Feasibility Assessment
Site initiation
- Preparing for initiation
- Content of initiation visit report
- Risks of inappropriate initiation
Monitoring visit procedures
- Preparing for monitoring
- SDV and virtual trials
- Identifying issues
- Visit report
Day 2
Study close-out visits
- Preparing for closure
- Documentation and data entry
- Closeout visit content
Planning Patient recruitment strategies
- Optimising recruitment
- Managing recruitment problems
Oversight of monitoring
- Co-monitoring visits
- Sponsor monitoring oversight
- Monitor/CRO follow-up
GCP, documentation and archiving
- GCP Inspectors requirements
- TMF considerations
Reporting serious breaches and preventing fraud
- Signs of serious breaches and fraud
- Monitor actions
- Reporting breaches
Preparing for audit and inspection visits
- Study site audit/inspection preparation
- QA departments and inspector focus
- Regulatory inspection findings review
For more information about this training visit https://www.researchandmarkets.com/r/mb9c13
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View source version on businesswire.com: https://www.businesswire.com/news/home/20250602727328/en/
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