1:00 to 2:00 pm ET - Impact of Systemic Non-Compliance
Nancy Wintering, MSW, LSW, 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 to 3:00 pm ET - Quality Management Systems (QMS): Design and Application
Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health
The objectives of this talk are to: 1) introduce the design of quality management systems in clinical research and 2) 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
Janelle Allen, MS, CCRP, Professional Consultant & Corporate Trainer, Faculty at 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.
4:15 to 4:30 pm ET – Faculty Question and Answer Session
1: 00 to 2:00 pm ET - Instituting an Internal Monitoring Program for Academic Institutions
Greg Staios, MSc, CCRP, Professor, Seneca College, School of Biological Sciences and Applied Chemistry, Clinical Research Program
Monitoring can be an effective method to complement an internal quality program by providing with ongoing and early information when quality issues may be becoming concerning within a particular study. While the benefits of such a program are clear, many institutions struggle with lack of resources and support to institute such programs. The aim this talk will be to provide attendees with key information regarding risk assessments, monitoring plan creation, monitor training and providing ongoing support and oversight of monitors in the field as well as providing them with a potential plan of action that could be instituted in their own institutions.
2:00 to 3:00 pm ET - Instilling Quality in the Design and Use of Study Tools
Jennifer Li, BSc, CCRP, Quality Manager, Cancer Clinical Research Unit, Princess Margaret Cancer Centre / University Health Network
Study tools are essential to good record keeping, effective communication, and maintaining protocol compliance in a clinical trial. The speaker will go over what it means to design study tools with quality in mind, and discuss the method of providing quality review of study tools by establishing a program-level working group. Through practical examples, the speaker will demonstrate how proper design and use of study tools is key to promoting GCP compliance, and how such tools can be incorporated into effective corrective and preventive actions (CAPAs).
3:00 to 3:15 pm ET – Break
3:15 to 4:30 pm ET -Panel Discussion: Quality Management Resources
Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality and Safety, Dartmouth-Hitchcock Medical Center
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office Yale Cancer Center, Senior Advisor, Quality Assurance and Regulatory Research Initiatives, Yale Center for Clinical Investigation
Jessica Rowe, MA, MS, CCRP, CIP, Associate Director, HRPP and Yale University, Center for Clinical Investigation, Regulatory Compliance & Quality
This panel discussion will provide the audience with the opportunity to engage in dialogue with Jessica, Alyssa, and Abby 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
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office Yale Cancer Center, Senior Advisor, Quality Assurance and Regulatory Research Initiatives, Yale Center for Clinical Investigation
Jessica Rowe, MA, MS, CCRP, CIP, Associate Director, HRPP and Yale University, Center for Clinical Investigation, Regulatory Compliance & Quality
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.
2:00 to 3:00 pm ET - Audit/Inspection Readiness: Part 2: Root Cause Analysis & Corrective and Preventative Action Plans
Alyssa Gateman, MPH, CCRP, Executive Director, Clinical Trials Office Yale Cancer Center, Senior Advisor, Quality Assurance and Regulatory Research Initiatives, Yale Center for Clinical Investigation
Jessica Rowe, MA, MS, CCRP, CIP, Associate Director, HRPP and Yale University, Center for Clinical Investigation, Regulatory Compliance & Quality
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
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.
4:15 to 4:30 pm ET – Faculty Question and Answer Session