1:00 – 2:00pm Revised (R3) Good Clinical Practice Guideline – Elevating Quality Management Practices (1.00 CE)
Abby Statler, PhD, MPH, MA, CCRP, Senior Director, Clinical Quality Assurance, AVEO Oncology
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office, Yale Cancer Center
Jessica Rowe, MA, MS, CCRP, CIP, Director for Quality and Education, Clinical Trials Office, Yale Cancer Center
Dr. Statler, Ms. Gateman and Ms. Rowe will focus on the key features of the 3rd International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline (ICH GCP E6 (R3)). They will also reveal the essential aspects from the following perspectives: Sponsor, Investigator, IRB and illustrate how the updated guidance elevates quality management practices across the clinical trial lifecycle.
2:00 to 3:00 pm ET - Quality Management Systems (QMS): Design and Application (1.00 CE)
Abby Statler, PhD, MPH, MA, CCRP, Senior Director, Clinical Quality Assurance, AVEO Oncology
Dr. Statler will introduce the design of quality management systems in clinical research and discuss how to apply the QMS principles when building a quality assurance program.
3:00 to 3:15 pm ET – Break
3:15 to 4:15 pm ET - Training and Tools Used to Assess and Control Risk within Clinical Trial Project Management (1.00 CE)
Janelle Allen, MS, CCRP, Consultant, Corporate Trainer & Faculty, Miami University
Ms. Allen 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.
4:15 to 4:30 pm ET – Faculty Question and Answer Session (0.25 CE)
1:00 to 2:00 pm ET - Impact of Systemic Non-Compliance (1.00 CE)
Nancy Wintering, MSW, LCSW, CCRP, Assistant Director of Research, Thomas Jefferson University
This session will provide an introduction to fraud and misconduct in clinical research. Noncompliance can occur on an individual or systemic basis. Ms. Wintering will provide an overview of definitions and ethical frameworks, and the cost and consequence of research misconduct. Discussion of scenarios will assist attendees in recognizing misconduct and identifying the underlying factors and risks that contribute to fraud and misconduct in research.
2:00 – 3:00pm Self-Monitoring implementation and tracking within a Comprehensive Cancer Center (1.00 CE)
Katrina Croghan, MS, CCRP, Quality Management Coordinator, Mayo Clinic
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).
3:00 to 3:15 pm ET – Break
3:15 to 4:30 pm ET -Panel Discussion: Quality Management Resources (1.25 CE)
Abby Statler, PhD, MPH, MA, CCRP, Senior Director, Clinical Quality Assurance, AVEO Oncology
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office, Yale Cancer Center
Jessica Rowe, MA, MS, CCRP, CIP, Director for Quality and Education, Clinical Trials Office, Yale Cancer Center
This panel discussion will provide the audience with the opportunity to engage in dialogue with Dr. Statler, Ms. Gateman and Ms. Rowe regarding their professional experiences related to quality management programs. The panelists will address how to secure organizational buy-in for quality measures, develop a workforce to support such activities, and provide tools to facilitate this work.
1:00 to 2:00 pm ET - Audit/Inspection Readiness: Part 1: Inspection Readiness & Conduct (1.00 CE)
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office, Yale Cancer Center
Jessica Rowe, MA, MS, CCRP, CIP, Director for Quality and Education, Clinical Trials Office, Yale Cancer Center
Ms. Gateman and Ms. Rowe 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.
2:00 to 3:00 pm ET - Audit/Inspection Readiness: Part 2: Root Cause Analysis & Corrective and Preventative Action Plans (1.00 CE)
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office, Yale Cancer Center
Jessica Rowe, MA, MS, CCRP, CIP, Director for 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.
3:00 to 3:15 pm ET – Break
3:15 to 4:15 pm ET - Using QA and QC trends to Drive Education and Training (1.00 CE)
Janelle Allen, MS, CCRP, Consultant, Corporate Trainer & Faculty, 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.
4:15 to 4:30 pm ET – Faculty Question and Answer Session (0.25 CE)