Updated agenda coming soon!
Impact of Systemic Non-Compliance
Nancy Wintering, MSW, LSW, CCRP, Assistant Director of Research, Thomas Jefferson University
This session will present the definitions of fraud and misconduct in clinical research. Noncompliance can occur in study design, while obtaining informed consent, collecting and analyzing data and in information dissemination and publishing. Scenarios will be presented to assist attendees in recognizing and mitigating factors that contribute to individual and systemic fraud and misconduct.
The Importance of Quality Management System (QMS) in the Conduct of Clinical Trials
Jennifer Gaskin, CCRP, Senior Director, CQA, Centrexion Therapeutics Corp.
This session will discuss the importance of QMS in clinical research. It will focus on the components of QMS, the implementation of Quality Assurance Programs, and the importance of institutional support.
Building a Quality Assurance Program to Manage the Risk Associated with Investigator-Initiated Studies
Abby Statler, PhD, MPH, MA, CCRP, Director, Research Quality & Safety, Dartmouth Health
The objective of this talk is to discuss how to develop and implement a Quality Assurance (QA) Program for Investigator-Initiated Trials (IITs). The presentation will focus on: 1) discussing the essential components of a successful IIT QA program and 2) providing the audience with strategies for program development and sustainability.
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.
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.
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).
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.
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.
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.
Panel Discussion
Course Faculty
This panel discussion will provide the audience with the opportunity to engage in dialogue with course faculty regarding all conference topics.