Monitoring/ Monitoring Effectiveness

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2024 Agenda

Fri., Sept. 27 1:15 to 2:00                                     Track: Monitoring / Monitoring Effectiveness
ABCs of Clinical Trial Monitoring

Ms. Neseth will discuss what tools and resources new clinical research monitors can use to make their lives easier. 809

Presenter: Tammy Neseth, MA, CCRP, Senior Manager Site Services, Quantum Leap Healthcare Collaborative

Fri., Sept. 27 2:05 to 2:50                                     Track: Monitoring / Monitoring Effectiveness
Monitoring Sponsor-Investigator Protocols: Lessons Learned from FDA Inspections

Monitoring of clinical trials is a pivotal aspect of quality control. Successful FDA inspections are often realized due to robust monitoring practices targeting specific components of subject protection, product management, and regulatory affairs. 811

Presenter: Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality and Safety, Dartmouth-Hitchcock Medical Center

Fri., Sept. 27 3:25 to 4:10                                     Track: Monitoring / Monitoring Effectiveness
Self-Monitoring implementation and tracking within a Comprehensive Cancer Center

Self-monitoring a site’s own Clinical Trials is critical, not only to address trial needs in real-time, but also to help address gaps in educational training, process improvement and more.  This presentation will focus on one Comprehensive Cancer Center’s self-monitoring process utilizing 1st and 3rd participant accruals on individual trials.  Ms. Croghan will walk through the reporting mechanism that communicates accrual numbers, review needs by the individual study teams and the enterprise Compliance and Quality Unit (CQU). 813

Presenter: Katrina Croghan, MS, CCRP, Quality Management Coordinator, Mayo Clinic

Fri., Sept. 27 4: 15 to 5:00                                    Track: Monitoring / Monitoring Effectiveness
Inspection Readiness: Are You Ready?

Mr. Wise will consider practical and useful recommendations on how to prepare for inspections and ensure proper monitoring of investigations. Not simply regurgitating the regulations but reading between the lines to understand the 'why' and to make smart, proactive choices throughout the clinical trial lifecycle. 815

Presenter: Andy Wise, BA, CCRC, CCRA, Associate Director, Elevation GCP Consulting, LLC.