8:30 to 9:00 am - Registration and Continental Breakfast
9:00 to 10:15 am - Keynote: What Enforcement Cases Teach Us About Quality Management (1.25 CE)
Craig Garmendia and Sarah Moeller
10:15 to 10:30 am - Break
10:30 to 11:45 am - International Conference for Harmonisation (ICH) Good Clinical Practice (GCP) E6 (R3) and Building Quality Management Systems (1.75 CE)
Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health
11:45 to 1:00 - Lunch
1:00-2:00 Training and Tools Used to Assess and Control Risk within Clinical Trial Project Management (1.00 CE)
Janelle Allen, MS, CCRP, Professional Consultant & Corporate Trainer, Faculty
Miami University
This session will detail best practices in assessing and mitigating risk in clinical trial project management. Review of professional tools and training pathways will be investigated to optimally equip teams.
2:00-2:30 pm - Break
2:30-3:45 pm - Self-Monitoring Implementation and Tracking within a Comprehensive Cancer Center (1.25 CE)
Katrina Croghan, Director, Applied Clinical Research Program
St. Cloud State University
3:45 to 4:45 pm - Breakout: Case-Based Risk Assessment Discussions (1.00 CE)
Attendees will break out into smaller groups to participate in exercises discussing risk assessments.
4:45 to 5:00 pm - Day 1 Wrap up / Q+A (0.25 CE)
Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health
8:30 to 9:00 am - Continental Breakfast
9:00 to 10:15 am - Understanding Systemic Non-Compliance (1.25 CE)
Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University
10:15 to 10:30 am - Break
10:30 to 12:00 pm - Audit and Inspection Readiness: From Notification to Close-Out (1.50 CE)
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office Yale Cancer Center
Jessica Rowe, MA, MS, CCRP, CIP, Director of Quality and Education, Clinical Trials Office, Yale Cancer Center
This session will cover the essentials of audit/inspection readiness, from pre-notification through close-out, including best practices for prospectively maintaining essential documents necessary for a successful audit/inspection. This session will also discuss audit/inspection conduct and offer tips and tools for successfully navigating audits/inspections.
12:00 to 1:00 pm - Lunch
1:00 to 2:00 pm - Audit/Inspection Readiness: Root Cause Analysis & CAPA Development (1.00 CE)
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office Yale Cancer Center
Jessica Rowe, MA, MS, CCRP, CIP, Director of Quality and Education, Clinical Trials Office, Yale Cancer Center
This session will build on the previous session, providing an in-depth discussion on conducting root cause analysis and developing corrective and preventative actions to address audit/inspection observations.
2:00 to 2:15 pm - Break
2:15 to 3:00 pm - Can we Really Conduct this Study? (.75 CE)
Tammy Neseth, MA, CCRP, Senior Manager Site Services, Quantum Leap Healthcare Collaborative
This session will provide attendees with strategies that will enable them to recognize when stress may be impacting themselves, their teams, and those they support in achieving quality outcomes. Techniques that could be utilized to reduce stress through both sustained or “in the moment” practices will be described.
3:00 to 3:45 pm - Leveraging QA and QC Trends for Targeted Training (.75 CE)
Janelle Allen, MS, CCRP, Professional Consultant & Corporate Trainer, Faculty at Miami University
This session will outline top QA and QC trends to elucidate ideal training and educational needs. It will help teams hone in on focus areas of interest to create efficiency and optimal performance.
3:45 to 4:45 pm - Interactive Panel: Hot Topics (1.00 CE)
4:45 to 5:00 pm - Conference Wrap up / Q+A (0.25 CE)
Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health